Rules for the manufacture and dispensing of medicinal products for medical use by pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities. Application

Ministry of Health of Russia

"On approval of the rules for the manufacture and dispensing of medicinal products for medical use pharmacy organizations, individual entrepreneurs with a pharmaceutical license / ConsultantPlus

• Order
• Application. Rules for the manufacture and dispensing of medicinal products for medical use by pharmacies and individual entrepreneurs holding a license for pharmaceutical activities
• I. General provisions
• II. Features of the manufacture of solid dosage forms
• Production of medicines in the form of powders
• Manufacturing of medicinal products in the form of homeopathic triturations
• Production of medicines in the form of homeopathic granules
• III. Features of the manufacture of liquid dosage forms
• Features of manufacturing liquid dosage forms using the mass-volume method
• Production of concentrated solutions
• Preparation of liquid dosage forms containing aromatic waters as a solvent
• Dilution of standard pharmacopoeial solutions
• Production of liquid dosage forms for non-aqueous solvents
• Preparation of solutions of high molecular weight substances
• Making drops
• Production of aqueous extracts from medicinal plant materials
• Preparation of solutions of protected colloids
• Production of suspensions and emulsions
• Preparation of homeopathic solutions and homeopathic dilutions
• Making homeopathic mixtures
• Making homeopathic drops
• Production of homeopathic syrups
• Preparation of homeopathic matrix tinctures and liquid homeopathic dilutions (according to Hahnemann)
• IV. Features of making ointments
• Production of homogeneous ointments
• Production of suspension ointments
• Production of emulsion ointments
• Production of combined ointments
• Making homeopathic ointments
• Making homeopathic oil
• V. Features of making suppositories
• Features of the manufacture of homeopathic suppositories
• Making suppositories using the rolling out method
• Making suppositories using the pouring method
• VI. Features of the manufacture of dosage forms under aseptic conditions
• Manufacturing of injection and infusion dosage forms
• Features of the manufacture of injection homeopathic solutions
• Manufacturing of ophthalmic dosage forms
• Features of the manufacture of homeopathic eye drops
• Making eye ointments
• Production of dosage forms intended for the treatment of newborns and children under 1 year of age
• Production of dosage forms with antibiotics
• VII. Quality control of medicinal products
• Acceptance control
• Written control
• Survey control
• Organoleptic control
• Physical control
• Chemical control
• Requirements for quality control of sterile solutions
• Control during the dispensing of drugs
• VIII. Rules for dispensing manufactured medicinal products
• Appendix No. 1. Labeling requirements for manufactured medicinal products for medical use
• Appendix No. 2
• Table N 1. Parameters of pharmaceutical mortars
• Table No. 2. Loss rates medicines when grinding in a mortar No. 1
• Appendix No. 3. Permissible deviations in mass, volume, concentration and errors during grinding in the manufacture of medicinal products for medical use
• Table No. 1. Permissible deviations in the mass of individual doses (including packaging) of powders
• Table N 1.1. Permissible deviations in the mass of individual doses (including packaging) of granules
• Table No. 2. Permissible deviations in the weight of a sample of individual drugs in powders and suppositories (when manufactured by the rolling out or pouring method)
• Table No. 3. Permissible deviations in the total volume of liquid dosage forms when manufactured by the mass-volume method
• Table No. 4. Permissible deviations in the weight of a sample of individual drugs in liquid dosage forms when manufactured by the mass-volume method
• Table No. 5. Permissible deviations in the total mass of liquid dosage forms when manufactured by the mass method
• Table No. 6. Permissible deviations in the weight of a sample of individual drugs in liquid dosage forms when manufactured using the method by weight and in ointments
• Table No. 7. Permissible deviations in the total mass of ointments
• Table N 7.1. Permissible deviations in the total mass of homeopathic ointments in tubes
• Table No. 8. Permissible deviations in the concentration of concentrated solutions
• Table No. 9. Permissible errors when measuring pH values
• Appendix No. 4
• Table No. 1. Acceptable standards for the manufacture of homeopathic granules
• Table No. 2. Particle size of dried raw materials of plant origin depending on its morphological group or the group of biologically active substances contained in it
• Appendix No. 5. Density values ​​of liquid medicines and excipients
• Appendix No. 6. Coefficients for increasing the volume of medicines
• Appendix No. 7
• Concentrated solutions recommended for measuring from a burette
• Data for the preparation of 1 liter of concentrated solution of some medicines
• Appendix No. 8. Requirements for the production of aromatic waters
• Appendix No. 9. Alcohol solutions
• Table No. 1. Correspondence of volumes (ml) of ethyl alcohol of various concentrations to mass (g) of 95% alcohol 20 °C
• Table No. 2. Correspondence of volumes (ml) of ethyl alcohol of various concentrations to mass (g) of 96% alcohol 20 °C
• Table No. 3. Standard alcohol solutions
• Table No. 4. Amounts of purified water and ethyl alcohol of concentration 96.1 - 96.9% in grams (g), which must be mixed at 20 ° C to obtain 1000 g of ethyl alcohol of concentration 30, 40, 50, 60, 70, 80, 90, 95, 96%% for the preparation of aqueous-alcoholic homeopathic solutions
• Appendix N 10. Number of drops in 1 gram and 1 milliliter, weight of 1 drop of liquid medicines at 20 °C according to a standard drop meter with deviations +/-5%
• Appendix No. 11. Water absorption coefficients of medicinal plant raw materials
• Appendix No. 12. Stabilizers of heterogeneous systems
• Appendix No. 13. Methods for producing homeopathic matrix tinctures from freshly harvested and (or) dried plant materials, mushrooms and raw materials of animal origin
• Method 1
• Method 2
• Method 2a
• Method 3
• Method 3a
• Method 3b
• Method 4
• Method 4a
• Methods 5.1 - 5.5
• Methods 6.1 - 6.3
• Methods 7.1 - 7.5
• Method 8
• Method 9a
• Method 9b
• Method 10a
• Method 10b
• Method 10b
• Method 10g
• Determination of juice content in fresh medicinal plant materials
• Method 1
• Method 2
• Appendix No. 14. Substitution rates (Ezh) and inverse substitution rates (I / Ezh) of some medicines
• Appendix No. 15. Requirements for sterilization regimes for medicinal products
• Table No. 1. Solutions for injections and infusions
• Other sterile solutions
• Table No. 2. Eye drops, irrigation solutions, concentrated solutions for making eye drops
• 2.1. Eye drops
• 2.2. Irrigation solutions
• 2.3. Concentrated solutions for making eye drops
• Table No. 3. Dosage forms intended for use in newborns and children under 1 year of age
• 3.1. Solutions for internal use
• 3.2. Solutions, oils for external use
• 3.3. Eye drops
• 3.4. Powders
• Table No. 4. Ointments
• Eye ointments
• Table No. 5. Homeopathic dosage forms

Order of the Ministry of Internal Affairs of the Russian Federation of August 27, 2008 N 751
"On measures to implement the Government Resolution Russian Federation dated August 5, 2008 N 583"

With changes and additions from:

December 10, 2008, July 6, 2009, October 1, 2010, March 15, 2012, January 15, November 27, 2013, May 5, 2014, July 20, 2015

In order to implement in the system of the Ministry of Internal Affairs of Russia the Decree of the Government of the Russian Federation of August 5, 2008 N 583 “On the introduction of new systems of remuneration for employees of federal budgetary, autonomous and government institutions and federal government agencies, as well as civilian personnel of military units, institutions and divisions of federal executive authorities, in which the law provides for military and equivalent service, whose remuneration is currently carried out on the basis of the Unified tariff schedule for remuneration of federal employees government agencies" - I order:

1. Establish for civilian personnel of military units, institutions and divisions of the Russian Ministry of Internal Affairs, whose remuneration is currently carried out on the basis of the Unified tariff schedule for remuneration of employees of federal government institutions, new remuneration systems in accordance with the Resolution.

2. Approve:

2.1. Salaries (official salaries, tariff rates) for civilian personnel of military units, institutions and divisions of the Russian Ministry of Internal Affairs (Appendix No. 1).

2.2. The procedure for determining the official salaries of heads of military units, institutions and divisions of the Russian Ministry of Internal Affairs, their deputies, and chief accountants (Appendix No. 2).

2.3. Conditions, amounts and procedure for making compensation payments to civilian personnel of military units, institutions and divisions of the Russian Ministry of Internal Affairs system (Appendix No. 3).

2.4. Conditions, amounts and procedure for making incentive payments to civilian personnel of military units, institutions and divisions of the Russian Ministry of Internal Affairs (Appendix No. 4).

2.5. The procedure for the formation and use of the wage fund for civilian personnel of military units, institutions and divisions of the Russian Ministry of Internal Affairs (Appendix No. 5).

2.6. List of institutions, departments and positions in which work gives the right to increased wages due to hazardous and difficult working conditions (Appendix No. 7).

3. Heads (chiefs) of divisions of the central apparatus of the Ministry of Internal Affairs of Russia, territorial bodies of the Ministry of Internal Affairs of Russia at the district, interregional and regional levels, educational, scientific, medical organizations of the system of the Ministry of Internal Affairs of Russia, district departments of logistics of the system of the Ministry of Internal Affairs of Russia, commanders of troops of operational-territorial formations , commanders of formations and military units, as well as other organizations and units created to perform tasks and exercise powers assigned to the internal affairs bodies of the Russian Federation:

3.1. Organize work to introduce new wage systems for civilian personnel of subordinate military units, institutions and divisions, with the involvement of trade union bodies (if any).

3.2. Transfer civilian personnel of subordinate military units, institutions and divisions to new remuneration systems, taking into account the recommendations of the Ministry of Health and Social Development of Russia on concluding an employment contract and its approximate form.

4. Allow the leaders (commanders, chiefs) of military units, institutions and divisions of the Russian Ministry of Internal Affairs system, constituent documents which provide for the receipt of funds from income-generating activities, independently determine the amount and procedure for directing these funds to make incentive payments to civilian personnel of these military units, institutions and divisions in accordance with the general permit (permit), as well as estimates of income and expenses for income-generating activities , approved in accordance with the established procedure.

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION ORDER Moscow October 26, 2015 N 751нOn approval of manufacturing and dispensing rulesmedicinal products for medical usepharmacy organizations, individualentrepreneurs holding a pharmaceutical license activity Registered by the Ministry of Justice of Russia on April 21, 2016.Registration N 41897In accordance with Article 56 of the Federal Law of April 12, 2010 N 61-FZ “On the Circulation of Medicines” (Collection of Legislation of the Russian Federation, 2010, N 16, Art. 1815) the order is:1. Approve the rules for the manufacture and dispensing of medicines for medical use by pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities, in accordance with the appendix.2. This order comes into force on July 1, 2016.Minister V.I. Skvortsova __________________ Application to the order of the Ministry of HealthRussian Federation Rules manufacturing and dispensing of medicinal products formedical use by pharmacy organizations,individual entrepreneurs with a license topharmaceutical activitiesI. General provisions1. These Rules establish requirements for the manufacture and dispensing of medicinal products for medical use by pharmacy organizations, individual entrepreneurs holding a license for pharmaceutical activities with the right to manufacture medicinal products for medical use (hereinafter referred to as the Rules, medicinal products, pharmacy organizations, individual entrepreneurs).2. These rules apply to the manufacture and dispensing of medicines by pharmacies and individual entrepreneurs, including prescriptions for medicines<1>and according to the invoice requirements of medical organizations<2>(hereinafter referred to as recipe, requirement).3. In the manufacture of medicinal products, pharmaceutical substances included in the state register of medicinal products for medical use (hereinafter referred to as medicinal products) are used.4. The quality of a manufactured medicinal product is determined by its compliance with the requirements of a pharmacopoeial monograph, a general pharmacopoeial monograph, or, in their absence, a document in the field of quality control containing requirements and methods for determining the quality of manufactured medicinal products (hereinafter referred to as the document in the field of quality control).5. Pharmacy organizations and individual entrepreneurs ensure the serviceability and accuracy of measuring instruments provided for by the regulatory, technical documentation of the manufacturer and meeting the requirements for their verification and (or) calibration provided for in Articles 13 and 18 of the Federal Law of June 26, 2008 N 102-FZ " On ensuring the uniformity of measurements"<3>used in the manufacture and quality control of medicinal products, as well as the regularity of their verification and (or) calibration.6. On all jars or bottles with a ground stopper (hereinafter referred to as the stopper) in which medicines are stored, the name of the medicinal product, the date of filling the stopper with the medicinal product, the expiration date (expiration date) (expiration date __________), the signature of the person who filled the stopper and confirming that the barbell contains exactly the specified drug.On containers with medicinal products intended for the preparation of solutions for injections and infusions, “For injection” is additionally indicated.Barbells with liquid medicines are provided with drop meters or pipettes. The number of drops in a certain volume or mass is indicated on the rod.7. The production of medicinal products is carried out under conditions that meet sanitary and epidemiological requirements<4>. _____________ <1>Order of the Ministry of Health of the Russian Federation dated December 20, 2012 N 1175n “On approval of the procedure for prescribing and prescribing medicines, as well as forms of prescription forms for medicines, the procedure for completing these forms, their accounting and storage” (registered by the Ministry of Justice of the Russian Federation on June 25 2013, registration N 28883), as amended by orders of the Ministry of Health of the Russian Federation dated December 2, 2013 N 886n (registered by the Ministry of Justice of the Russian Federation on December 23, 2013, registration N 30714, dated June 30, 2015 N 386n ( registered by the Ministry of Justice of the Russian Federation on August 6, 2015, registration No. 38379). <2>Chapter III of Appendix No. 13 to the order of the Ministry of Health and social development of the Russian Federation of December 12, 2007 N 110 “On the procedure for prescribing and prescribing medicines, medical products and specialized medical nutrition products” (registered by the Ministry of Justice of the Russian Federation on April 27, 2007, registration N 9364), as amended by orders Ministry of Health and Social Development of the Russian Federation dated August 27, 2007 N 560 (registered by the Ministry of Justice of the Russian Federation on September 14, 2007, registration N 10133), dated September 25, 2009 N 794n (registered by the Ministry of Justice of the Russian Federation on November 25, 2009 ., registration N 15317), dated January 20, 2011 N 13n (registered by the Ministry of Justice of the Russian Federation on March 15, 2011, registration N 20103), by order of the Ministry of Health of the Russian Federation dated February 26, 2013 N 94n (registered by the Ministry of Justice of the Russian Federation June 25, 2013, registration N 28881). <3>Collection of Legislation of the Russian Federation 2008, No. 26, Art. 3021; 2014, N 26, art. 3366; N 30, art. 4255. <4>Federal Law of March 30, 1999 N 52-FZ “On the sanitary and epidemiological welfare of the population” (Collected Legislation of the Russian Federation, 1999, N 14, Art. 1650; 2003, N 2, Art. 167; N 27, Art. 2700 ; 2004, N 35, Art. 3607; 2005, N 19, Art. 1752; 2007, N 49, Art. 6070; 2008, N 29, Art. 3418; 2009, N 1, Art. 17; 2011, N 1 , Art. 6; N 30, Art. 4590, Art. 4596; 2012, N 26, Art. 3446; 2013, N 27, Art. 3477; N 30, Art. 4079; N 48, Art. 6165; 2014, N 26, art. 3366, 3377)When producing concentrated solutions, semi-finished products, drugs in the form of in-pharmacy preparations and packaging of drugs, all entries are made in a laboratory and packaging journal, drawn up on paper or electronically.The laboratory and packaging work log contains the following information:a) date and serial number carrying out control of the medicinal product (raw material) issued for use; b) series number; c) name of the medicinal product (raw material), unit of measurement, quantity, retail price, retail amount (including the cost of dishes);d) serial number of packaged products, unit of measurement, quantity, retail price, retail amount, including for tablet drugs, drugs in the form of powders, dosage liquid dosage forms, deviation;e) signature of the person who packaged the medicinal product (raw materials);f) signature of the person who checked the packaged medicinal product (raw materials), date and analysis number.The journal of laboratory and packaging work must be numbered, laced and sealed with the signature of the head of the pharmacy organization (individual entrepreneur) and a seal (if there is a seal).8. Packaging of manufactured medicinal products is carried out depending on the form and method of use of the medicinal product.During the packaging process of manufactured medicinal products, the general appearance of the packaging, the correct use of packaging materials, and packaging labeling are checked.Medicines manufactured in the form of powders under aseptic conditions, sterile and aseptically prepared liquid dosage forms, eye ointments are packaged in sterile packaging.Ointments are packaged in wide-mouth jars, containers, tubes and other containers that are convenient for use.Liquid dosage forms are packaged in tightly closed containers.Suppositories are packaged in individual primary packaging and placed in secondary packaging (box or bag).9. Labeling of manufactured medicinal products must comply with the requirements specified in Appendix No. 1 to these Rules.II. Features of the manufacture of solid dosage formsProduction of medicines in the form of powders10. Medicines in the form of powders (hereinafter referred to as powder) can be:simple (consisting of one ingredient);complex (consisting of two or more ingredients);dosed (divided into separate doses);undosed (not divided into separate doses).11. Powders are produced using mixers and grinders or in mortars, taking into account their physical and chemical properties.The mixture for making powders is divided into doses using manual scales and electronic scales or dispensers according to the weight of one powder and their quantity specified in the recipe or requirement.Medicines in quantities less than 0.05 g per total mass of powder are used in the form of trituration (a mixture of medicine and excipient) 1:10 or 1:100.12. When producing powders in a mortar, the total mass of the powder should not exceed the maximum loading of the mortar, taking into account the mortar parameters defined in Table No. 1 of Appendix No. 2 to these Rules.Grinding and mixing of powders is carried out by adding ingredients sequentially from smaller quantities to larger quantities in a pre-grinded mortar with a pharmacologically indifferent excipient or drug, observing losses in accordance with Table No. 2 of Appendix No. 2 to these Rules.When making powders, the remaining ingredients are added in order of increasing mass, maintaining a ratio of 1:20.Medicines with coloring properties are added to the mortar at the last stage of mixing powders or between layers of non-coloring medicines.Easily atomizing drugs are added to the mortar last.Medicines that are difficult to grind (thymol, iodine, camphor, menthol, boric acid and other substances) are crushed, if necessary, using a liquid drug (for example, ethyl alcohol 95% at the rate of 10 drops per 1 g of the substance being crushed).Liquid medicines are added to the crushed powder mixture last, while maintaining the main property of the powder - flowability.13. Permissible deviations in the mass of individual doses (including during packaging) of powders are indicated in Table No. 1 of Appendix No. 3 to these Rules.Manufacturing of medicinal products in the formhomeopathic triturations14. A medicinal product in the form of homeopathic trituration is a solid dosage form in the form of a powder consisting of one or more crushed active components and (or) their dilutions with an excipient. Lactose monohydrate is used as an excipient (unless otherwise indicated in the recipe).15. The preparation of homeopathic triturations is carried out in the following ways:production of homeopathic trituration from solid medicines;production of homeopathic trituration from homeopathic matrix tinctures, homeopathic solutions and liquid homeopathic dilutions.The production of homeopathic triturations is carried out using the mass method using mass parts.16. In homeopathic triturations, the size of the resulting particles of the original substance in the first decimal or first hundredth dilution should not exceed 100 microns.17. Making homeopathic trituration from solid medicines.To make homeopathic triturations up to the fourth decimal or fourth hundredth dilution, inclusive, the required amount of lactose monohydrate or other excipient is divided into three equal parts. The first part is placed in a mortar and ground to close the pores of the mortar. Then the entire amount of the active component is added, ground with force for 6 minutes, after which the powder is raked with a non-metallic spatula and scraped off the walls of the mortar. This operation is repeated again. Then the second and third parts of lactose monohydrate are added sequentially, repeating the operations described above with each part. The minimum time required for the entire process of making homeopathic trituration is 1 hour.To make a homeopathic trituration above the fifth decimal or fifth centesimal dilution, dilutions are obtained from part of the homeopathic trituration of the previous decimal or centesimal dilution and 9 or 99 parts of lactose monohydrate, previously divided into three equal parts. To the first part of lactose monohydrate, the entire amount of homeopathic trituration of the previous dilution is gradually added in small portions and thoroughly ground until a homogeneous powder is obtained. Then the second and third parts of lactose monohydrate are added sequentially and thoroughly ground until smooth.18. Making homeopathic trituration from homeopathic matrix tinctures, homeopathic solutions and liquid homeopathic dilutions.When preparing a homeopathic trituration with homeopathic matrix tinctures, homeopathic solutions and liquid homeopathic dilutions, the entire required amount of lactose monohydrate is gradually, in small portions, added to the entire amount of homeopathic matrix tincture, homeopathic solution or liquid homeopathic dilution of the previous dilution and thoroughly mixed until a homogeneous mass is obtained. The homogeneous wet mixture is carefully dried, crushed if necessary and mixed again.When making homeopathic trituration, such an amount of lactose monohydrate is used so that after completion of the manufacturing process the required mass is achieved.Homeopathic matrix tinctures, homeopathic solutions and liquid homeopathic dilutions used for the preparation of homeopathic triturations are potentiated in ratios corresponding to the methods of their preparation. During production, so much lactose monohydrate is used that the total mass of the homeopathic trituration after drying is 10 parts for a decimal dilution and 100 parts for a hundredth dilution.Subsequent dilutions of homeopathic triturations from homeopathic matrix tinctures, homeopathic solutions or liquid homeopathic dilutions are obtained from 1 part of the homeopathic trituration of the previous dilution and 9 parts (for the decimal scale) or 99 parts (for the hundredth scale) of lactose monohydrate, thoroughly mixing until smooth.Manufacturing of medicinesin the form of homeopathic granules19. A medicinal product in the form of homeopathic granules (hereinafter referred to as homeopathic granules) is a solid dosage form for oral administration in the form of spheres of the same diameter containing the active component ( active ingredients) in homeopathic dilutions.20. Homeopathic granules are prepared by saturating or applying a liquid homeopathic dilution of one or more active ingredients to an auxiliary component - granules obtained from sucrose, lactose or other suitable sugars approved for medical use.To ensure uniform distribution of liquid homeopathic dilutions, homeopathic granules must be of the same size.The sizes of homeopathic granules vary in numbers from 1 to 12 depending on their diameter, unless otherwise specified.Homeopathic granules are classified by the number of granules in 1 gram. The number of homeopathic granules is counted in two parallel samples in a sample weighed with an accuracy of 0.01 grams. Acceptable standards for the manufacture of homeopathic granules are defined in Table No. 1 of Appendix No. 4 to these Rules.Permissible deviations in the mass of individual doses (including packaging) of homeopathic granules are indicated in Table No. 1.1 of Appendix No. 3 to these Rules.21. The production of homeopathic granules is carried out in the following ways:saturation of sugar granules with liquid homeopathic dilution or a mixture of dilutions;layering liquid homeopathic dilution onto sugar granules.22. Saturation of sugar granules with liquid homeopathic dilution or a mixture of dilutions.Sugar granules are saturated with appropriate liquid homeopathic dilutions or a mixture of liquid homeopathic dilutions prepared with 62% alcohol (by weight), which corresponds to 70% (percent by volume). The alcohol content in the dilution and mixture must be at least 60% (by weight), which corresponds to 68% (by volume).If the alcohol concentration is lower than required, the preparation of a decimal or centesimal dilution intended to saturate homeopathic granules is carried out using 62% alcohol (by weight) or 70% (by volume).To evenly distribute the dilution, sugar granules are pre-moistened with alcohol 62% (by weight) or 70% (by volume), which is added at the rate of 1 gram per 100 granules.Saturation of sugar granules with liquid homeopathic dilutions or mixtures is carried out by mixing in mechanical mixers without moving working parts or manually (for a mass of up to 2 kg) in glass tightly closed vessels.The working volume of the mixer should be 1.5 - 2 times greater than the loaded mass of granules. The mixing process in mechanical mixers is carried out within 3-4 minutes, with the manual method - within 10 minutes.The wet granules are dried in air at room temperature to a constant weight.When producing homeopathic granules using the described method, it is not allowed to saturate sugar granules with liquid homeopathic dilutions below the third hundredth dilution obtained from volatile and odorous substances, as well as from all acids.23. Layering liquid homeopathic dilution onto sugar granules is carried out by:layering homeopathic aqueous dilutions: to obtain 100 grams of homeopathic granules, 1 gram of homeopathic aqueous dilution or aqueous mixture is shaken with 9 grams of sugar syrup and the resulting 10 grams of the mixture are evenly layered on sugar granules, the mass of which is calculated by the formula (100 - X) grams, where X - amount of sugar in sugar syrup, in grams;layering homeopathic triturations: to obtain 100 grams of homeopathic granules, 10 grams of trituration are shaken with 20 grams of sugar syrup, the resulting mixture is evenly layered onto sugar granules, the mass of which is calculated by the formula (100 - X - Y) grams, where X is the amount of sugar in the sugar syrup , in grams, Y - the amount of excipient contained in the homeopathic trituration, in grams;layering mixtures: mixtures are prepared in accordance with the section “Preparation of homeopathic mixtures” of Chapter III of these Rules by jointly shaking aqueous homeopathic dilutions and (or) homeopathic triturations in sugar syrup. To obtain 100 grams of homeopathic granules, 1 gram of the prepared mixture is shaken with 9 grams of sugar syrup and 10 grams of the resulting dilution are evenly layered on sugar granules, the mass of which is calculated by the formula (100 - X - Y) grams, where X is the amount of sugar in the sugar syrup, in grams, Y - the amount of excipient contained in homeopathic triturations, in grams.Layering of liquid homeopathic dilutions of active ingredients in sugar syrup onto granules is carried out in pans with controlled heating. Sugar granules are placed in a pan, preheated to 37-42°C, and slowly rotated until the entire mass of granules is heated to the above temperature. Homeopathic dilutions of the active ingredients in sugar syrup are poured into the pan gradually, in small equal portions, at regular intervals. At the end of layering, heating of the pan is stopped, and its rotation continues to dry the granules to a constant mass.III. Features of the manufacture of liquid dosage forms24. Liquid dosage forms include solutions in aqueous and non-aqueous solvents, mixtures, aqueous extracts from medicinal plant materials, solutions of high molecular weight substances, solutions of protected colloids, suspensions, emulsions, homeopathic solutions, dilutions, mixtures.Liquid dosage forms are prepared by the mass-volume method, the mass method or the volume method.25. The mass-volume method produces aqueous and aqueous-alcoholic solutions of powdered medicines.26. The mass method produces solutions of powdered and liquid medicines in viscous and volatile solvents dosed by mass, as well as emulsions, suspensions, regardless of their concentration, and homeopathic dosage forms.Fatty and mineral oils, glycerin, dimexide, polyethylene glycols (polyethylene oxides), silicone liquids, ether, chloroform, benzyl benzoate, validol, vinylin (Shostakovsky balsam), birch tar, ichthyol, lactic acid, essential oils, turpentine, methyl salicylate, nitroglycerin are dosed by weight. , perhydrol.27. The volumetric method is used to prepare ethyl alcohol solutions of various concentrations and solutions of liquid standard pharmacopoeial solutions (except for perhydrol).Purified water and water for injection, aqueous solutions of medicines, galenic and new galenic medicines (tinctures, liquid extracts, adonizide, etc.) are also dosed by volume.28. When indicated in a recipe or requirement as a component to be manufactured, the medicinal product “water” is used purified water, “alcohol” is ethyl alcohol, “ether” is diethyl ether (medicinal); "glycerin" - medical glycerin containing 10-16% water, with a density of 1.223 - 1.233 g/cm. cubeIf a solvent is not specified in the recipe or requirement, purified water is used.The deviation in the total volume or weight of liquid dosage forms should not exceed the permissible deviations in volume and weight provided for in tables No. 4 - No. 6 of Appendix No. 3 to these Rules.Features of the manufacture of liquid medicinal productsforms by mass-volume method29. When making liquid dosage form using the mass-volume method, the total volume is determined by the sum of the volumes of liquid medicines and excipients included in the dosage form, calculated, if necessary, taking into account the density values ​​of liquid medicines and excipients specified in Appendix No. 5 to these Rules.Permissible deviations in the total volume of liquid dosage forms when manufactured by the mass-volume method are defined in Table No. 3 of Appendix No. 3 to these Rules.The change in the total volume of the liquid dosage form when dissolving powdered medicines is not taken into account if they fall within the deviations allowed in the total volume of liquid dosage forms when manufactured by the mass-volume method, in accordance with Table No. 3 of Appendix No. 3 to the Rules.If the change in the volume of the liquid dosage form when dissolving powdered medicines is greater than the permissible norms, then when dissolving the powders, the change in the volume of the liquid dosage form is calculated taking into account the coefficients of increase in the volume of medicines in accordance with Appendix No. 6 to these Rules, or the dosage form should be prepared in measuring containers. The drug volume expansion coefficient shows the increase in the volume of solution in milliliters when 1 gram of drug or excipient is dissolved at 20°C.30. When preparing liquid dosage forms with an aqueous dispersion medium, first of all, the calculated volume of water (purified or aromatic) is measured, in which powdered drugs and excipients are sequentially dissolved, taking into account solubility and their possible interaction.31. To accelerate the dissolution of drugs, preliminary grinding of drugs, heating of the solution, stirring, complexation and solubilization are used.32. First, narcotic, psychotropic, and potent drugs are dissolved in a measured volume of purified water; further - other drugs, taking into account their solubility.33. After dissolving powdered drugs, the solutions are filtered through a filter material, which is selected taking into account the properties of the solvent and the drug.Instead of powdered medicines, pre-made concentrated solutions (in a burette) specified in Appendix No. 7 to these Rules, which are added after dissolving the powdered medicines and filtering the solution, can be used in the liquid dosage form.34. During production aqueous solutions medicines containing a significant amount of water of crystallization in the molecule, capable of weathering, as well as hygroscopic medicines, their concentrated solutions should be used.35. The liquid ingredients included in the dosage form are added to the aqueous solution in the following sequence: aqueous non-volatile and odorless liquids; other non-volatile liquids miscible with water; aqueous volatile liquids; liquids containing ethyl alcohol, in order of increasing concentration; other non-aqueous volatile and odorous liquids.Production of concentrated solutions36. Concentrated solutions are prepared by the mass-volume method in volumetric containers under aseptic conditions using freshly obtained purified water.Permissible deviations in the concentration of concentrated solutions are given in Table No. 8 of Appendix No. 3 to these Rules.37. The prepared concentrated solutions are filtered, subjected to full chemical control and checked for the absence of mechanical inclusions.38. Containers with concentrated solutions are issued with labels indicating the name and concentration of the solution, date of manufacture, expiration date, batch and analysis number and signature of the person who checked the solution.Changes in color, turbidity, the appearance of flakes, deposits earlier than the established expiration date are signs of unsuitability of solutions.Production of liquid dosage forms,containing aromatic waters as a solvent39. Aromatic waters are prepared in accordance with the requirements specified in Appendix No. 8 to these Rules and are stored in a cool place, protected from light.40. Aromatic waters are dosed by volume. Permissible deviations in the total volume of liquid dosage forms when manufactured by the mass-volume method are given in Table No. 3 of Appendix No. 3 to these Rules.When the total volume of a liquid dosage form is indicated in a prescription or required, the volume of aromatic water is determined by subtracting the volumes of all liquid ingredients from the total volume of the dosage form, and the change in volume when dissolving powdered drugs is also taken into account if the change in volume is greater than the permissible norms.41. When producing liquid dosage forms in which the main dispersion medium is aromatic water, concentrated solutions of drugs are not used.Dilution of standard pharmacopoeial solutions42. When diluting pharmacopoeial solutions prescribed under a chemical name (for example, formaldehyde solution), the calculation of the original drug is carried out taking into account the actual content of the substance in the solution.When prescribing a pharmacopoeial solution under a code name (for example, formalin solution), the concentration of the original drug is taken as one (100%).Production of liquid dosage formson non-aqueous solvents43. Solutions based on viscous and volatile solvents (except alcohol solutions) are prepared by weight. The total mass is determined by summing up all the ingredients included in the dosage form.44. When preparing solutions with viscous and volatile solvents, medications and excipients are dosed directly into a dry bottle for dispensing, then the solvent is weighed or measured.45. When using viscous solvents, heating is used taking into account the physicochemical properties of drugs.46. ​​Alcohol solutions are prepared by the mass-volume method. The amount of ethyl alcohol specified in the recipe or requirement must correspond to volumetric units of measurement.If there is no indication of the concentration of ethyl alcohol in the recipe or requirement, 90% ethyl alcohol is used.When producing liquid non-aqueous dosage forms, ethyl alcohol is dosed by volume, without reducing the volume specified in the recipe or requirement by the amount of its increase when the drugs are dissolved. The total volume is taken into account when controlling the quality of the dosage form.When the total volume of solution is indicated in a recipe or requirement, the volume of ethyl alcohol is determined by subtracting all liquid ingredients from the total volume, and the change in volume when dissolving powdered medicines is also taken into account if the change in volume is greater than the permissible deviations specified in Table No. 3 of Appendix No. 3 to these Rules.The compositions of standard alcohol solutions are given in Table No. 3 of Appendix No. 9 to these Rules.47. If a recipe or requirement specifies a solution having several concentrations, without indicating the concentration, having several concentrations, the solution of the lowest concentration is dispensed.48. Accounting for consumed ethyl alcohol is carried out by weight in terms of concentration in accordance with tables No. 1 and No. 2 of Appendix No. 9 to these Rules.Preparation of solutions of high molecular weight substances49. Solutions of high-molecular substances are prepared by the mass-volume method (for example, solutions of pepsin, gelatin) or by mass (for example, solutions of starch, cellulose ethers).To dissolve limited-swelling high-molecular substances, technological methods of swelling and heating (for example, solutions of gelatin, starch) or cooling (for example, methylcellulose solution) are used.Making drops50. In order to maintain volume and concentration, drugs are dissolved in part of the purified water. The resulting solution is filtered through a filter washed with water, the remaining amount of water is filtered through the same filter until the specified volume is obtained.When making drops using combined solvents (ethyl alcohol, glycerin, oils and other solvents), the solubility of drugs and the composition of the solvent are taken into account, as well as the number of drops in 1 gram and 1 milliliter, the weight of 1 drop of liquid drugs at 20°C using a standard drop meter with deviations +-5% in accordance with Appendix No. 10 to these Rules.Preparation of aqueous extracts from medicinalvegetable raw materials51. Aqueous extracts (infusions, decoctions and others) are prepared by extracting medicinal plant materials with purified water, as well as dissolving dry or liquid extracts standardized in a calculated volume of purified water.When producing aqueous extracts, it is not allowed to replace medicinal plant materials with tinctures, essential oils and extracts not intended for the production of aqueous extracts.Aqueous extracts are stored in a cool place in packaging that ensures their quality is preserved.52. When calculating the volume of purified water required for extraction, the values ​​of the coefficients of water absorption of medicinal plant raw materials are used in accordance with Appendix No. 11 to these Rules and the value of the coefficients for increasing the volume of medicines provided for in Appendix No. 6 to these Rules, if changes in the total volume of the liquid dosage form when dissolving powdered medicines, they exceed the permissible deviations specified in Table No. 3 of Appendix No. 3 to these Rules.53. When producing aqueous extracts, optimal extraction conditions are ensured, taking into account, among other things, the standard of medicinal plant raw materials, its grinding and histological structure, the ratio of the mass of raw materials and the volume of the extractant, the physicochemical properties of active drugs and related substances.54. Multicomponent aqueous extracts from medicinal plant raw materials, requiring the same extraction regime, determined by the physico-chemical properties of the active and accompanying substances, are prepared in one infundibulum glass without taking into account the histological structure of the medicinal plant raw material and taking into account the water absorption coefficients established in Appendix No. 11 to these Rules.Multicomponent aqueous extracts from medicinal plant raw materials, requiring different extraction conditions, are prepared separately using the maximum possible volume of purified water for extraction, but not less than 10 times the mass of the medicinal plant raw material.55. When preparing aqueous extracts from medicinal raw materials, the use of concentrated solutions of medicinal products is not allowed. Powdered drugs are dissolved in the finished aqueous extract with stirring and filtered through the same filter that was used to filter the aqueous extract. If necessary, the volume of the dosage form is adjusted with purified water to the volume specified in the recipe or requirement.56. In the preparation of aqueous extracts, standardized dry and liquid extracts are used. Dry standardized extracts are added to liquid dosage forms according to the rules for dissolving powdered drugs, and liquid extracts - according to the rules for adding alcohol-containing drugs.Preparation of solutions of protected colloids57. Solutions of protected colloids protargol, collargol, ichthyol are prepared by the mass-volume method.Solutions of protargol are made by scattering it on the surface of purified water and leaving until completely dissolved.Collargol solutions are prepared by first grinding it and mixing it with purified water. Colloidal solutions filtered through ash-free paper or glass filters.Production of suspensions and emulsions58. Suspensions and emulsions are prepared in a mortar or using mixers of various designs.Suspensions and emulsions, regardless of concentration, are prepared by weight.When making suspensions and emulsions in mixers, all ingredients are placed in the apparatus and mixed until a homogeneous mass is obtained. The mixing time is determined by the properties of the drugs and the design of the device.Suspensions are not subject to filtration.59. The production of suspensions in a mortar by grinding powdered insoluble drugs is carried out according to the rules for the production of powders, followed by dispersion with an optimal amount of liquid (in the amount of 1/2 of the weight of the grinded drug or the grinded drug and stabilizer) and dilution with a dispersion medium.60. The production of a suspension from hydrophobic drugs is carried out using stabilizers of heterogeneous systems specified in Appendix No. 12 to these Rules, and taking into account the physicochemical properties of drugs and stabilizers, as well as the method of use of the dosage form.61. In the manufacture of emulsions, emulsifiers are used, the choice of which is determined by their technological and physicochemical properties, the amount of oil phase and the purpose of the emulsion.Emulsions are prepared in a mortar through the stage of primary emulsion with calculation of the amount of its ingredients, followed by dilution with a dispersion medium.The method of introducing drugs into emulsions is determined by their physicochemical properties.Preparation of homeopathic solutionsand homeopathic dilutions62. Homeopathic solutions and homeopathic dilutions are prepared by weight and used as substances for the manufacture of homeopathic medicines or as medicines for internal, external and local use.Homeopathic dilutions are obtained by stepwise dilution, accompanied by shaking homeopathic solutions, homeopathic triturations, homeopathic matrix tinctures.Purified water, water for injection, isotonic sodium chloride solution, glycerin, ethyl alcohol or another solvent specified in the pharmacopoeial monograph or quality control document are used as solvents.The quantities of purified water and ethyl alcohol for the preparation of water-alcohol solutions of various concentrations are given in Table No. 4 of Appendix No. 9 to these Rules.Homeopathic dilutions are prepared in a room protected from direct sunlight, using tightly sealed glass vessels, the volume of which is 1/2 - 1/3 larger than the volume of the active component being diluted. During the manufacturing process, each dilution is potentiated by shaking.In the case of using purified water or water for injection as a solvent for the preparation of homeopathic dilutions (homeopathic solutions), the labeling indicates “aqueous”.Aqueous homeopathic dilutions are used for the manufacture of homeopathic injection solutions, ointments, suppositories, and homeopathic eye drops.Homeopathic aqueous dilutions, intended for the preparation of ointments and suppositories, are prepared using purified water.63. To obtain homeopathic dilutions (homeopathic solutions), the methods of Hahnemann, Korsakov and the LM method are used.When using Hahnemann's method, decimal dilutions (1:10) are designated by the letter "D", hundredth dilutions (1:100) by the letter "C", indicating the number of dilution steps (potentiation) in Arabic numerals. When making each decimal or hundredth dilution, a separate vessel is used.To prepare solutions of the first decimal (D1) or first hundredth dilution (C1), 1 part of the substance is dissolved in 9 parts or 99 parts of the solvent and shaken (potentiated), unless otherwise specified in the pharmacopoeial monograph.The second decimal dilution (D2) is prepared from 1 part solution (D1) and 9 parts 43% alcohol (by weight), unless a different diluent is specified in the quality control document. Subsequent dilutions are prepared in the same way. The second centesimal dilution (C2) is prepared from 1 part of the solution (C1) and 99 parts of 43% alcohol (by weight), unless a different solvent is specified in the quality control document. Subsequent dilutions are prepared in the same way.Methods for obtaining dilutions of homeopathic matrix tinctures are given in Appendix No. 13 to these Rules.If, when preparing a solution, the use of 15% alcohol (by weight) is required, then the first decimal dilution (D1) is obtained as follows: one part of the substance is dissolved in 7.58 parts of water and 1.42 parts of 94% alcohol (by weight) is added. To obtain the first hundredth dilution (C1), one part of the substance is dissolved in 83.4 parts of water and 15.6 parts of 94% alcohol (by weight) is added to it;When preparing homeopathic dilutions (homeopathic solutions) according to Korsakov, dilutions are designated by the letter “K” indicating the number of dilution steps (potentiation) in Arabic numerals. With this method, centesimal dilutions are prepared in the same vessel. The first hundredth dilution is prepared in accordance with the method used in preparing the tincture of the homeopathic matrix or substance. A measured amount of homeopathic matrix tincture or substance is placed in the first vessel, the required amount of the appropriate solvent is added and shaken, resulting in the first hundredth dilution. The resulting dilution is transferred to a second vessel, designated K1, by turning it upside down or by suction. 99 parts of the solvent are added to the first vessel containing one part of the first centesimal dilution and shaken, resulting in the second centesimal dilution according to Korsakov. The resulting dilution is transferred to the third vessel designated K2. All subsequent dilutions are obtained similarly, each time pouring 99 parts of the solvent into the same first vessel until the required dilution is achieved. In the case of using an insoluble substance, the first three potentized homeopathic triturations are prepared with lactose monohydrate, unless otherwise indicated, according to the method given in Chapter II of the section “Manufacture of medicinal products in the form of homeopathic triturations” of these Rules. Subsequent dilutions are prepared using a liquid solvent according to the above method.LM dilutions (1:50000) are designated by the letters “LM” indicating the number of dilution steps (potentiation) in Roman numerals. LM dilutions (50-thousandth potencies) are prepared from triturations of substances in the third hundredth dilution (C3), by sequential potentiation in a ratio of 1:50,000 and are designated by the letters “LM” (L - 50; M - 10,000). During the manufacturing process, each dilution is potentiated by shaking 100 times. For LM dilutions, a scale is used from LM I to LM XXX, that is, there are 30 dilution levels (potentiation). Unlike decimals and hundreds, dilution levels for the LM dilution scale are indicated by Roman numerals.To obtain a dilution of LM I: 0.06 g of homeopathic trituration of the third hundredth dilution (C3) is dissolved in 20 ml of 15% alcohol (by weight) and shaken (which corresponds to 500 drops). One drop of the resulting solution is transferred into a tightly closed vessel with a capacity of 5-10 ml, 2.5 ml of 86% alcohol (by weight) is added (which corresponds to 100 drops) and shaken vigorously 100 times. The resulting dilution evenly moistens 100 grams of sugar granules (about 470-530 granules in 1 gram). After soaking in a tightly closed vessel, the granules are dried in air at room temperature to a constant weight. The resulting granules correspond to the LM I dilution.To obtain a dilution of LM II: one granule in a dilution of LM I is transferred into a tightly closed vessel with a capacity of 5-10 ml, dissolved in one drop of purified water, 2.5 ml of alcohol 86% (by weight) is added (corresponding to 100 drops) and shaken vigorously 100 times. The resulting dilution is applied to the next 100 grams of sugar granules as indicated above.Subsequent LM dilutions are obtained similarly.To obtain liquid LM dilutions from LM dilutions of granules, one granule of the appropriate LM dilution is dissolved in 10 ml of 15% alcohol (by weight). A solution is obtained whose LM dilution corresponds to the LM dilution of the granule taken for dissolution.64. To prepare homeopathic dilutions (according to Hahnemann) from homeopathic triturations, two methods are used:Method 1. To obtain the fourth centesimal liquid dilution (C4), 1 part of the triturated substance of the third hundredth dilution (C3) is dissolved in 79 parts of water, 20 parts of 86% alcohol (by weight) are added and shaken. The fifth centesimal (C5) and all subsequent centesimal dilutions are prepared from one part of the previous centesimal dilution and 99 parts of 43% alcohol (by weight) with shaking.Method 2. To obtain the sixth decimal liquid dilution (D6), 1 part of the trituration substance of the fourth decimal dilution (D4) is dissolved in 9 parts of water and shaken. Then one part of the resulting dilution is shaken with 9 parts of 30% alcohol (by weight).Similarly, the seventh decimal liquid dilution (D7) is obtained from the homeopathic trituration of the fifth decimal dilution (D5), and the eighth decimal liquid dilution (D8) is obtained from the homeopathic trituration of the sixth decimal dilution (D6).From the ninth (D9) and above, decimal dilutions are prepared from previous decimal dilutions with 43% alcohol (by weight) in a ratio of 1:10.To obtain the sixth centesimal liquid dilution (C6), one part of the homeopathic trituration of the fourth hundredth dilution (C4) is dissolved in 99 g of water and shaken. Then 1 part of the resulting dilution is shaken with 99 parts of 30% alcohol (by weight).Similarly, the seventh hundredth dilution (C7) is obtained from the homeopathic trituration of the fifth hundredth dilution (C5), and the eighth hundredth dilution (C8) is obtained from the trituration of the sixth hundredth dilution (C6).From the ninth (C9) and above, liquid centesimal dilutions are prepared from the previous liquid centesimal dilution using 43% alcohol (by weight) in a ratio of 1:100.Liquid dilutions from triturations D6, D7, C6 and C7 obtained using the described method cannot be used to obtain subsequent dilutions.Making homeopathic mixtures65. Homeopathic mixtures are mixtures of homeopathic triturations, homeopathic matrix tinctures, homeopathic solutions or homeopathic dilutions with various auxiliary substances and are intended for the production of medicines.The degree of dilution of active components in homeopathic mixtures is obtained by their successive stepwise dilution (potentiation) using an auxiliary substance (for example, solvent, carrier), which is added in a ratio of 1:10, 1:100 or in another ratio specified in the recipe or requirement.The degree of dilution of active components in homeopathic mixtures corresponds to the number of steps of their dilution when preparing homeopathic mixtures.66. Homeopathic mixtures are obtained in two ways:Method 1. Each active component included in the homeopathic mixture is pre-potentiated to the required degree of dilution and then the prescribed amount (by weight) of each resulting dilution is mixed;Method 2. The prescribed amount (by weight) of each active component, taken in dilution a number of steps below the final one, is mixed and together potentiated to the required degree of dilution in the mixture.67. Jointly potentiated:1) homeopathic mixtures containing only liquid homeopathic dilutions, in the preparation of which ethyl alcohol of various concentrations is used as a solvent (or extractant), maintaining a ratio of 1:10 or 1:100. The composition of such homeopathic mixtures may include homeopathic matrix tinctures, liquid homeopathic dilutions of homeopathic triturations, homeopathic solutions and (or) their dilutions. At each stage of potentiation, one part of the mixture is shaken with 9 or 99 parts of ethyl alcohol of the concentration specified in the recipe or requirement. If homeopathic mixtures are intended to be incorporated into dosage forms for parenteral use or eye drops, the last two decimal dilutions or the last hundredth dilution are potentiated using water for injection or sodium chloride 0.9% solution for injection;2) trituration homeopathic and liquid homeopathic dilutions obtained using water, water-salt or water-glycerin solutions as a solvent (or extractant). The composition of such mixtures may include aqueous solutions, aqueous dilutions of homeopathic triturations, homeopathic matrix tinctures obtained from fresh or dried plant raw materials by maceration and fermentation in a mixture of water with whey, honey or lactose, homeopathic matrix tinctures obtained by maceration of raw materials of animal origin in a mixture of glycerin and sodium chloride solution. At each stage of potentization, one part of the homeopathic mixture is shaken with 9 or 99 parts of the solvent specified in the recipe or requirement. If homeopathic mixtures are intended for inclusion in dosage forms for parenteral use or eye drops, then the last two decimal dilutions or the last hundredth dilution are potentiated using water for injection, sodium chloride solution 0.9% for injection, isotonic solution containing 0.2 parts sodium bicarbonate, 8.8 parts sodium chloride and 91 parts water for injection or other solvent specified in the monograph, general monograph or quality control document. When producing such homeopathic mixtures, you should be guided by the requirements of sections “Features of the manufacture of injection homeopathic solutions” and “Features of the manufacture of homeopathic eye drops” of these Rules. When preparing mixtures (with joint potentiation of homeopathic trituration and liquid homeopathic dilutions), 64% sugar syrup is used to apply the initial sugar granules by layering at the last stage of potentiation. In all other cases, water for injection is used to potentiate mixtures;3) homeopathic mixtures containing only homeopathic triturations, made from powders, homeopathic matrix tinctures, homeopathic solutions and (or) their dilutions.At each stage of potentiation, 1 part of the mixture is mixed and ground with 9 or 99 parts of milk sugar in accordance with the requirements of Chapter II of the section “Manufacture of medicinal products in the form of homeopathic triturations” of these Rules.Making homeopathic drops68. Homeopathic drops are a liquid dosage form containing one or more active ingredients in appropriate homeopathic dilutions.Homeopathic drops are prepared by weight and may contain one or more active ingredients.Homeopathic matrix tinctures, their homeopathic dilutions, homeopathic solutions, and liquid homeopathic dilutions are used as active components in the production of homeopathic drops. The last decimal or hundredth dilution of the active component is potentiated using the solvent provided in the homeopathic drops.Purified water, glycerin, alcohol, fatty and mineral oils, and another solvent specified in the pharmacopoeial monograph, general pharmacopoeial monograph or quality assurance document are used as solvents in the manufacture of homeopathic drops.69. Manufactured homeopathic drops are packaged using measuring cups or various dispensers according to volume.Production of homeopathic syrups70. Homeopathic syrup is a syrup containing one or more active ingredients in appropriate homeopathic dilutions.71. Homeopathic syrup is made by dissolving the syrup-forming component in boiling purified water. The resulting syrup is filtered hot into a sterile container. The sugar concentration in homeopathic syrup cannot be more than 72%.Homeopathic matrix tinctures or their homeopathic dilutions, homeopathic solutions and liquid homeopathic dilutions, homeopathic triturations and (or) their homeopathic dilutions are added to the cooled syrup.Alcohol is used as a preservative for the production of homeopathic syrup; the use of other preservatives is not permissible.The resulting homeopathic syrup is filtered through thick cloth or other suitable material.The sugar concentration in the medicinal product must be at least 64%.Production of homeopathic matrix tinctures andliquid homeopathic dilutions (according to Hahnemann)72. Homeopathic matrix tinctures are liquid extracts from freshly collected or dried raw materials of plant and/or animal origin, a mixture of plant juice with ethanol.73. Raw materials of plant origin are crushed to form a paste, and dried - to particles, the size of which is indicated in Table No. 2 of Appendix No. 4 to these Rules.Dried raw materials of plant origin, intended for the production of homeopathic matrix fermented tinctures, are crushed to a particle size that passes through a sieve with holes no larger than 0.5 mm.When preparing fermented homeopathic tinctures, the following must be observed: temperature regime, pH values ​​of the medium, duration of infusion and mixing mode. The temperature regime (heating) is maintained using thermostats. The extraction process is intensified by thoroughly mixing the macerates twice a day.Animals, their parts or their secretions are used as raw materials for the production of homeopathic matrix tinctures on glycerin. In this case, the processing of parts of higher animals (warm-blooded) is carried out immediately after slaughter, lower animals are killed immediately before processing in a stream of carbon dioxide.74. Homeopathic matrix tinctures are obtained by percolation or maceration with ethanol of the appropriate concentration, maceration with purified freshly prepared water with the addition of honey or a mixture of honey with lactose or freshly prepared whey, maceration with glycerin in the presence or without sodium chloride.Descriptions of methods for making homeopathic matrix tinctures are given in Appendix No. 13 to these Rules.75. Whey used for the production of homeopathic matrix fermented tinctures is prepared from fresh natural raw cow's milk with a density of at least 3 1027 kg/m. The milk is heated to a boil and boiled for 5 minutes. After cooling, the milk is fermented with lactic acid bacteria Lactobacillacea and kept in a dark place at a temperature of about 25°C for 3 days.To obtain the starter, the whey is separated by filtration through a sterile cloth.1 liter of fresh natural raw cow's milk of the highest grade is placed in a coarse ceramic vessel, 10 ml of the resulting starter is added and left to ferment in a place protected from light at a temperature of about 25°C for 3 days. The resulting self-pressed, durable clot without gas bubbles is separated, and the serum is filtered through a sterile cloth. The first 100 ml of the filtrate is discarded.For infusion (maceration), tightly closed coarse ceramic or glass vessels are used.IV. Features of making ointments76. According to the type of dispersed systems, ointments can be homogeneous (alloys, solutions), heterogeneous (suspension and emulsion) and combined.Depending on the consistency properties, ointments are divided into ointments themselves, gels, creams, pastes and liniments.Ointments are made by weight. Permissible deviations in the total mass of ointments are indicated in tables No. 6, No. 7 of Appendix No. 3 to these Rules.Ointments are made in mixers or in a mortar.77. Excipients are used to make ointments: ointment bases, preservatives, antioxidants, absorption activators.The ointment base must ensure the specific activity of the ointment, not disrupt skin function, and not cause allergic reactions or other side effects.Ointments introduced into body cavities, applied to extensive wounds and burn surfaces, are prepared under aseptic conditions.Production of homogeneous ointments78. Homogeneous ointments include ointment-alloys and ointment-solutions.Ointments-alloys on lipophilic bases are obtained by fusing the ingredients taking into account their melting point.Ointment solutions on lipophilic bases are obtained by dissolving fat-soluble drugs in a molten base.Ointment solutions on hydrophilic bases are obtained by dissolving water-soluble drugs in water or other liquids, taking into account solubility, then mixing with the base or dissolving in it.Production of suspension ointments79. In the manufacture of suspension ointments, drugs are crushed and then dispersed with an optimal amount of liquid.When the solid phase content in the ointment is less than 5%, the drugs are crushed with an additionally introduced liquid related to the base, in an amount approximately equal to half the mass of the crushed drugs.When the solid phase content in the ointment is from 5% to 25%, the medicines are crushed with a part of the molten base equal to half the mass of the medicines, the rest of the base is taken in unmelted form.When the solid phase content of the ointment is 25% or more, a molten base is used to disperse and dilute the concentrate.Production of emulsion ointments80. Emulsion ointments on lipophilic and diphilic bases contain aqueous or alcoholic solutions of drugs. Emulsion ointments on hydrophilic bases contain hydrophobic liquids.Protargol, collargol, dry extracts and other water-soluble drugs are introduced into emulsion ointments in the form of aqueous solutions, which are dissolved in water, taking into account the solubility of the drug and the permissible deviations in the total mass of ointments specified in Table No. 7 of Appendix No. 3 to these Rules.The resulting solutions are emulsified and mixed with the remaining amount of base.Liquid drugs are emulsified by the base.Production of combined ointments81. When making combined ointments, drugs are introduced into the ointment base, taking into account the physicochemical properties of the drugs.Technological methods used in the production of combined ointments must prevent unwanted interactions of drugs with each other or separation of the ointment during production and storage, and ensure the production of a homogeneous mass.Making homeopathic ointments82. Homeopathic ointments consist of a base and one or more active components of homeopathic dilutions evenly distributed in it.Based on the consistency and composition of the base, homeopathic ointments are divided into:homeopathic ointments (a soft dosage form consisting of a base and one or more active components of homeopathic dilutions evenly distributed in it);homeopathic opodeldoks (soap liniment consisting of a mixture of active components of homeopathic dilutions and base).83. When preparing homeopathic ointments, active components are introduced in the form of homeopathic matrix tinctures and (or) their dilutions, homeopathic triturations, solutions of homeopathic and liquid homeopathic dilutions, substances of synthetic, mineral and natural origin or other origin.In the manufacture of homeopathic ointments, bases of natural origin are used: hydrophobic - fatty and hydrocarbon (lanolin, vegetable oils, beeswax, spermaceti, petroleum jelly, vaseline oil, paraffin), hydrophilic - gels of high molecular weight carbohydrates and proteins (tragacanth, agar, gelatin, starch, honey , glycerin) or other bases specified in the pharmacopoeial monograph, general pharmacopoeial monograph or quality assurance document.84. Homeopathic matrix tinctures, included in homeopathic ointments in a concentration of more than 5%, before mixing with the base, are either evaporated (under vacuum) to half the amount taken, or to incorporate them into petroleum jelly, 5-10% of anhydrous lanolin or an emulsifier are added to it.The concentration of active components in homeopathic ointments is indicated in the form of dilutions.Homeopathic opodeldocs are prepared in a ratio of 1:10 or in other ratios.The basis for homeopathic liquid opodeldocs is obtained by mixing soap alcohol, purified water and 95% alcohol in a weight ratio of 2:1:1 or in other ratios.Homeopathic matrix tinctures or homeopathic dilutions in a concentration of 3%, 5%, 10% or other concentrations, mixtures of homeopathic matrix tinctures or mixtures of dilutions of homeopathic matrix tinctures, or homeopathic dilutions, or other medicines are used as active components in homeopathic opodeldocs. Volatile and odorous ingredients are added last.The production of homeopathic ointments containing metal powders is carried out by mixing 1 part of the metal powder with 9 parts of the ointment base. The size of 80% of the metal particles in this case should be no more than 10 microns and there should be no particles larger than 50 microns.Homeopathic ointments do not contain stabilizers, antioxidants or preservatives. The addition of preservatives is allowed only in cases where gels containing water or direct emulsions (oil-in-water type) are used as a base.Permissible deviations in the total mass of homeopathic ointments in tubes are indicated in Table No. 7.1 of Appendix No. 3 to these Rules.Making homeopathic oil85. Homeopathic oil is a liquid dosage form in the form of an extract or solution for external use, consisting of homeopathic medicines and vegetable or mineral oil.Homeopathic oil is prepared:maceration of dried plant or animal raw materials with vegetable or mineral oil;mixing essential oils and vegetable or mineral oils;by another method ensuring the production of a stable dosage form.Homeopathic oil may contain one or more ingredients.86. Homeopathic oil is prepared by weight in the ratio: (1:10) or (1:20) or in other ratios.Olive, peanut, sunflower, stone fruit and others are used as oils. vegetable oils or mineral oils approved for medical use.Medicines based on oils can be monocomponent or complex. Complex oil-based medicines are prepared by mixing monocomponent oils, a potentized base and other possible ingredients with or without oils.Homeopathic oil is prepared in the following ways.Method 1. Homeopathic oil is made from 1 part by weight of dried plant or animal raw materials and 10 or 20 parts by weight of oil. The weight part of the crushed plant material is placed in a closed vessel and moistened with 0.25 parts by weight of 95% ethyl alcohol. The mixture is covered and left to stand for 12 hours, and then mixed with 10 or 20 parts by weight of oil and kept at a temperature of 60-70 ° C for 4 hours. After this, the resulting mixture is squeezed out and filtered. It turns out 10% or 5% homeopathic medicine oil based.Method 1a. One part of the crushed raw material is placed in a closed vessel, into which 10 or 20 parts of oil are added (for raw materials containing potent substances), heated to 37 ° C and maintained at this temperature for 7 days, stirring in the morning and evening for 5 minutes. The mixture is then squeezed out and filtered.Method 2. Homeopathic oil is made by mixing 1 part by weight essential oil with 9 or 19 parts by weight of oil or other ratios used as a base. The result is 10% or 5% or another concentration of homeopathic preparations based on oils.Method 3. To obtain oil dilution D3, first 1 part of liquid homeopathic dilution D1 is shaken with 9 parts of absolute ethyl alcohol. From 1 part of this dilution, a liquid homeopathic dilution D3 is prepared in the same way. One part of the liquid homeopathic dilution D3 is mixed with 99 parts of the oil used as a base. This mixture is an oil dilution of D3.Oil dilution D4 is prepared in a similar way from liquid homeopathic dilution D2, and oil dilutions D5 and higher are prepared in the same way.Method 3a. One part of the homeopathic trituration is mixed with 99 parts of the oil used as a base until homogeneous, and the oil is introduced in sequential parts. Mixing time with the base is 20 minutes.Method 4. Homeopathic oil is made by mixing 1 part of homeopathic dilution or a mixture of homeopathic dilutions with 9 parts of mineral oil or in other ratios. The introduction of aqueous and alcohol components is carried out step by step or using an emulsifier (lanolin, its derivatives or cocoa butter).Method 5. The production of combined homeopathic oils, which include homeopathic dilutions or mixtures of homeopathic dilutions, oil extracts, essential and synthetic oils, is carried out taking into account the physico-chemical properties of all components included in the composition. Technological techniques used in the production of combined oils must prevent unwanted interactions of drugs with each other, and must also be introduced into the base in a certain sequence, depending on the composition of the oil. Odorous and volatile components are added last.V. Features of making suppositories87. Excipients are used to make suppositories: drug carriers (bases), preservatives, antioxidants, absorption activators.Suppositories are made by weight using the methods of rolling, pressing and pouring.In the pour-out method, fat-soluble drugs are dissolved in a lipophilic base.In the rolling-out method, fat-soluble drugs are ground with a portion of the crushed base or an optimal amount of auxiliary liquid related to the base. When a eutectic mixture is formed, compactors are added.Water-soluble drugs are dissolved in a minimum amount of solvent, taking into account their solubility and permissible deviations in the weight of a sample of individual drugs in powders and suppositories (when manufactured by rolling out or pouring out), specified in Table No. 2 of Appendix No. 3 to these Rules.Medicines that are insoluble neither in water nor in the base are introduced into the base in the form of minute powders.Features of the manufacture of homeopathic suppositories88. Homeopathic suppositories contain one or more active ingredients in appropriate homeopathic dilutions.Homeopathic suppositories contain active ingredients in homeopathic dilutions, evenly distributed in the suppository base.Homeopathic matrix tinctures and (or) homeopathic dilutions and (or) their mixtures, homeopathic triturations are used as active components.In the manufacture of homeopathic suppositories, cocoa butter, lanolin and hydrogenated fats are used as a base.Suppositories for children are prepared based on cocoa butter or solid fat.Active components are introduced into the base, observing a ratio of 1:10 (decimal scale) or 1:100 (hundredth scale) or in other ratios. When administered, the active components are mixed with the base directly or after dissolving or rubbing with a small amount of molten base, water, alcohol-water-glycerin mixture, vaseline oil or other solvent.The weight of one suppository for children should be about 1.0 g, for adults 1.5 - 2.0 g.Active components in liquid form, which do not contain volatile active ingredients, can be concentrated by evaporation before mixing with the base.Heat-labile active components are added to the base immediately before the formation of suppositories.The addition of surfactants, preservatives and dyes is not allowed.Homeopathic suppositories are formed by rolling out, pressing or pouring the molten mass into injection molds.When forming homeopathic suppositories using the pouring method, the prepared mass is preliminarily melted when heated and poured into appropriate forms. Suppositories harden when cooled. To ensure hardening, it is allowed to add auxiliary components such as solid fats, cocoa butter, lanolin and glycerin.When forming homeopathic suppositories using the rolling method, anhydrous lanolin is used as a binder.Making suppositories using the rolling out method89. When making suppositories using the rolling method, cocoa butter is first crushed into chips and its calculated amount is added in parts to the medicines. The resulting suppository mass is crushed in a mortar to improve plasticity.A bar or cylindrical rod of a certain length is formed from the resulting suppository mass. Dosing and preparation of suppositories are carried out.Making suppositories using the pouring method90. Special molds are used to make suppositories using the pouring method.When calculating the amount of suppository base, the volume of the mold cavity, the nature of the base and the content of drugs are taken into account.When the drug content is 5% or more, the substitution coefficient (E) or the inverse substitution coefficient is taken into accountg (I/E) in accordance with Appendix No. 14 to these Rules. and Before pouring, molds for making suppositories are pre-cooled and lubricated with a liquid not related to the suppository base.VI. Features of the manufacture of dosage forms inaseptic conditions91. There are requirements for the production of dosage forms under aseptic conditions aimed at minimizing the risk of contamination by microorganisms and mechanical particles.92. The quality of manufactured solutions for injections and infusions, ophthalmic dosage forms and dosage forms intended for the treatment of newborns and children under 1 year of age, dosage forms with antibiotics, drugs in the form of intrapharmacy preparations is determined in accordance with the quality control methods established by the pharmacopoeial monograph , a general pharmacopoeial monograph, or, in its absence, a document in the field of quality control.In the absence of methods for quality control of medicinal products established by a pharmacopoeial monograph, a general pharmacopoeial monograph or a document in the field of quality control, the production of dosage forms intended for use in newborns and children under 1 year of age is carried out under the supervision of a pharmacist-analyst or a pharmacist performing control tests. functions in the manufacture and dispensing of medicines.Manufacturing of injection and infusion dosage forms93. Manufactured injection and infusion solutions must be free from visible mechanical inclusions, sterile, stable, and withstand the pyrogenicity test.Additional requirements for manufactured infusion solutions are their isotonicity, isohydricity, isoionicity, and isoviscosity.Injection and infusion solutions are prepared under aseptic conditions using the mass-volume method using water for injection.94. The simultaneous production at one workplace of several injection and infusion solutions containing drugs with different names or drugs of the same name in different concentrations is prohibited.It is prohibited to produce injection and infusion solutions in the absence of data on the chemical compatibility of the drugs included in them, the technology and sterilization regime, as well as in the absence of quality control methods established by the pharmacopoeial monograph, the general pharmacopoeial monograph, or in the absence of one - a document in the field of quality control.95. Injection and infusion solutions are filtered using approved filter materials and installations. Filtering the solution is combined with simultaneous filling of it into prepared sterile vials, which are sealed with sterile stoppers.The time interval from the start of production of the injection and infusion solution to sterilization should not exceed 3 hours.96. Injection and infusion solutions are sterilized in accordance with the requirements for sterilization regimes specified in Table No. 1 of Appendix No. 15 to these Rules.Sterilization of solutions with a volume of more than 1 liter and repeated sterilization of injection and infusion solutions are not allowed.The sterilization process must ensure that the entire load volume is effectively sterilized.The parameters and effectiveness of thermal sterilization methods are monitored using instrumentation, chemical and biological tests.97. Sterilization regimes for source drugs, manufactured injection and infusion solutions, as well as auxiliary materials and utensils are registered in the logbook for registering the sterilization regime for source drugs, manufactured drugs, auxiliary materials, utensils and other materials.The logbook for registering the sterilization regime for initial medicinal products, manufactured medicinal products, auxiliary materials, utensils and other materials shall indicate the following information:a) date and serial number of sterilization;c) name of the material to be sterilized;d) the quantity of initial medicines, manufactured medicines, auxiliary materials, utensils and other materials;e) sterilization conditions (temperature, time); f) thermal test; g) signature of the person who sterilized the materials.The logbook for registering the sterilization regime of original medicines, manufactured medicines, auxiliary materials, utensils and other materials must be numbered, laced and sealed with the signature of the head of the pharmacy organization (individual entrepreneur) and a seal (if there is a seal).98. Injection and infusion solutions of drugs requiring protection from exposure elevated temperature, are sterilized by filtration in a laminar air flow using membrane filters with a nominal pore size of no more than 0.22 microns and depth filters with equivalent properties for retaining microorganisms.Immediately before filling the bottle, it is recommended to re-filtrate the solution through an additional sterilizing filter that retains microorganisms.The final sterilizing filtration of the solution should be carried out directly near the filling site. Filters with minimal fiber separation should be used.99. The quality assessment of injection and infusion solutions before sterilization is carried out by appearance, absence of mechanical inclusions, pH value, authenticity and quantitative content of drugs, content of isotonic and stabilizing substances.The assessment of the quality of injection and infusion solutions after sterilization is carried out by appearance, the absence of mechanical inclusions, checking the nominal volume when filling into bottles, the pH value, the permissible errors in the measurement of which are given in Table No. 9 of Appendix No. 3 to these Rules, the authenticity and quantitative content of medicinal products products, deviation from the nominal volume, closure fixation, sterility, pyrogenicity or bacterial endotoxin content.If one of the listed requirements does not meet, the solutions are of poor quality.100. When manufacturing medicinal products for injections and infusions, all stages of manufacturing are recorded in a logbook for recording the results of control of individual stages of manufacturing medicinal products for injections and infusions.In the logbook for recording the results of control of individual stages of manufacturing solutions for injections and infusions, the following information is indicated:a) date and serial number of the control;b) prescription or requirement number;c) name and quantity of starting materials taken (including water);d) name and volume of the prepared solution;e) signature of the person who prepared the solution;f) filtering and packaging (bottling) (indicate the volume in milliliters and the number of bottles (flasks));g) signature of the person who packaged the solution;h) signature of the person who carried out the initial inspection of the solution for mechanical inclusions;i) sterilization (indicate temperature, time “from” and “to”, thermal test, signature of the person who sterilized the solution for mechanical inclusions);j) signature of the person who carried out the secondary control of the solution for mechanical inclusions;k) numbers of tests before and after sterilization (indicated through a fraction);m) the number of containers of finished products received for release;m) signature of the person who approved the manufactured medicinal products for dispensing (the approval of manufactured solutions for injections and infusions for dispensing is carried out by a responsible person appointed by the head of the pharmacy organization, or an individual entrepreneur holding a license for pharmaceutical activities).The journal for recording the results of control of individual stages of manufacturing solutions for injections and infusions must be numbered, laced and sealed with the signature of the head of the pharmacy organization (individual entrepreneur) and a seal (if there is a seal).Features of manufacturing injection homeopathic solutions 101. Injectable homeopathic solutions are a sterile liquid dosage form containing one or more active ingredients in appropriate homeopathic dilutions.The conditions and rules for the manufacture of homeopathic injection solutions must comply with the conditions and rules for the manufacture of injection and infusion dosage forms.For the production of injection homeopathic solutions, water for injection is used as a solvent.When preparing injection homeopathic solutions from aqueous-alcoholic dilutions, the content of ethyl alcohol in the finished solution should not exceed 0.5% or should be minimal. To do this, at the last two stages (with potentiation on a decimal scale) or at the last stage (with potentiation on a hundredth scale), an isotonic solution prepared in water for injection is used.Sodium chloride is used for isotonication. The use of other excipients, with the exception of substances for isotonication and maintaining a constant pH value, is not allowed.Manufacturing of ophthalmic dosage forms102. Ophthalmic dosage forms include eye drops, irrigation solutions, eye ointments, eye lotions.For the manufacture of ophthalmic dosage forms, drugs and auxiliary substances (solvents, ointment bases, stabilizers, buffer solutions, isotonic substances, preservatives, prolongators, and others) are used.103. Aqueous ophthalmic dosage forms must be sterile and isotonic, unless otherwise indicated in pharmacopoeial monographs, have an optimal pH value corresponding to the pH of the tear fluid - 7.4 (pH limits from 3.5 to 8.5 are allowed), stable during storage and comply with the requirements of the pharmacopoeial monograph, general pharmacopoeial monograph or quality control document for visible mechanical inclusions.104. Eye drops and solutions are prepared under aseptic conditions using the mass-volume method using purified water.When making eye drops and solutions, medications are dissolved in a sterile container in a calculated volume of purified water, excipients are added if necessary, and filtered using approved filter materials and installations.When producing small volumes of eye drops, medications and excipients are dissolved in part of purified water, the resulting solution is filtered through filter material pre-washed with purified water, then the remaining amount of purified water is filtered through the same filter.Eye drops and solutions are sterilized in accordance with the requirements for sterilization modes specified in Table No. 2 of Appendix No. 15 to these Rules.The absence of mechanical inclusions in eye drops and solutions is determined before and after sterilization.105. Solutions of medicinal products that require protection from exposure to elevated temperatures are prepared under aseptic conditions using sterile purified water without subsequent sterilization or using sterilization by filtration.106. Eye drops containing narcotic drugs, psychotropic, poisonous, potent substances are necessarily subject to full chemical control.Features of the manufacture of homeopathic eye drops107. Homeopathic eye drops contain one or more active ingredients in appropriate homeopathic dilutions.The production of homeopathic dilutions is regulated by Chapter III of the section “Production of homeopathic solutions and homeopathic dilutions” of these Rules.Homeopathic eye drops are prepared by weight under aseptic conditions. Freshly prepared purified water, isotonic sodium chloride solution or buffer solutions are used as solvents.108. Before adding dilutions of homeopathic active ingredients or mixtures thereof to homeopathic eye drops, the last two decimal dilutions or the last hundredth dilution are potentiated using freshly prepared purified water or a 0.9% sodium chloride solution or an isotonic solution consisting of 0.2 parts of sodium bicarbonate, 8.8 parts sodium chloride and 91 parts freshly prepared purified water.When potentiating dilutions of active components containing ethyl alcohol and intended for the manufacture of eye drops, the concentration of residual alcohol in the eye drops should not exceed permissible norm(no more than 0.005 g in 1.0 g).Excipients are added to homeopathic eye drops after the final potentiation of the active components.Making eye ointments109. Eye ointments are prepared under aseptic conditions on a sterile ointment base. Requirements for sterilization regimes for eye ointments are indicated in Table No. 4 of Appendix No. 15 to these Rules.The ointment base should not contain impurities, should be neutral, sterile, and evenly distributed over the mucous membrane of the eye.Eye ointments are prepared using the mass method.If the recipe or requirement does not contain instructions on the composition of the ointment base, an alloy of petroleum jelly, which does not contain reducing substances, and anhydrous lanolin in a ratio of 9:1 is used.110. Medicines are introduced into the base of the eye ointment as a solution, emulsion, suspension.An ointment solution is prepared by dissolving medications in a sterile ointment base.An absorption-based emulsion ointment is prepared by dissolving water-soluble drugs (including resorcinol and zinc sulfate) in a minimum amount of sterile purified water and mixing with an ointment base.Medicines are introduced into the suspension ointment in the form of tiny powders after thorough dispersion with a small amount of sterile auxiliary liquid (with a medicine content of up to 5%) or part of the molten base (with a medicine content of 5% or more).111. Eye ointments containing narcotic drugs, psychotropic, poisonous, potent substances are necessarily subject to full chemical control.Production of dosage forms intended fortreatment of newborns and children under 1 year of age112. Dosage forms intended for the treatment of newborns and children under 1 year of age are prepared under aseptic conditions according to the rules for the manufacture of dosage forms established by these Rules.113. Dosage forms intended for the treatment of newborns and children under 1 year of age, including solutions for internal and external use, depending on the nature of the drugs included in their composition and the manufacturing process, are divided into two groups: solutions, which are sterilized in the final packaging, and solutions prepared under aseptic conditions in a sterile solvent without subsequent thermal sterilization.114. In accordance with the requirements for sterilization regimes specified in Table No. 3 of Appendix No. 15 to these Rules, the following dosage forms intended for use in newborns and children under 1 year of age are sterilized:solutions for internal and external use made with purified water;oils for external use;heat-resistant powders (xeroform).Production of dosage forms with antibiotics115. All dosage forms containing antibiotics are prepared under aseptic conditions.When producing powders with antibiotics, the requirements established in the section “Manufacture of medicinal products in the form of powders” of Chapter II of these Rules are taken into account. Heat-resistant ingredients are pre-sterilized.Ointments and suppositories with antibiotics are manufactured according to the rules for the manufacture of appropriate dosage forms established by these Rules. The base for ointments is pre-sterilized.VII. Quality control of medicinal products116. Quality control of manufactured and manufactured medicinal products is carried out through:acceptance control;written control;survey control;organoleptic control;physical control;chemical control;control during the dispensing of drugs.All manufactured medicinal products are subject to mandatory written, organoleptic control upon release.117. The results of organoleptic, physical and chemical control of manufactured medicinal products, including in the form of in-pharmacy preparation and packaging, concentrated solutions, triturations, ethyl alcohol are registered in the logbook for recording the results of organoleptic, physical and chemical control of medicinal products manufactured according to prescriptions, requirements and in the form of in-pharmacy preparations, concentrated solutions, triturations, ethyl alcohol and packaging of medicines.This log contains the following information:a) date of control and serial number;b) prescription number, requirements, name of the medical organization that issued them (if any);c) batch number of the industrially produced medicinal product;d) composition of the medicinal product: analyte or ion (indicated during physical or chemical control of dosage forms prepared according to prescriptions);e) results of physical, organoleptic, quality control (each on a scale: positive or negative), chemical control (qualitative and quantitation); f) full name of the person who manufactured and packaged the medicinal product;g) signature of the person who checked the manufactured medicinal product;h) conclusion based on the results of the written control: satisfactory or unsatisfactory.The log of registration of the results of organoleptic, physical and chemical control of medicinal products manufactured according to prescriptions, requirements and in the form of in-pharmacy preparations, concentrated solutions, triturations, ethyl alcohol and packaging of medicinal products must be numbered, laced and signed by the head of the pharmacy organization (individual entrepreneur) and seal (if there is a seal).Acceptance control118. Acceptance control is organized in order to prevent the receipt of substandard medicines used for the manufacture of medicines, as well as low-quality packaging materials, into a pharmacy organization or an individual entrepreneur.All incoming medicines (regardless of the source of their receipt) are subject to acceptance control.119. Acceptance control consists of checking incoming medicines for compliance with the requirements for the following indicators: “Description”, “Packaging”, “Labeling”, as well as checking the correctness of execution of accompanying documents, including documents confirming the quality of medicines.The control according to the “Description” indicator includes checking the appearance, physical state, color, and smell of the medicinal product. If doubts arise about the quality of medicines, samples are sent to an accredited testing laboratory (center) for additional testing. Such medicines with the designation “Rejected during acceptance control” are stored in the quarantine zone of the storage room, isolated from other medicines.When checking for the “Packaging” indicator, special attention is paid to its integrity and compliance with the physicochemical properties of medicines.When monitoring by the “Labelling” indicator, the compliance of the labeling of the primary and secondary packaging of the medicinal product with the requirements of the document in the field of quality control, the presence of an insert leaflet in Russian in the packaging (or separately in the pack for the entire quantity of finished medicinal products) is checked.Written control120. When manufacturing medicinal products, including according to prescriptions and requirements, as well as in the form of in-pharmacy preparations, a written control passport is filled out, which indicates:a) date of manufacture of the medicinal product;b) prescription or requirement number;c) name of the medical organization, name of the department (if available); batch number, quantity in a batch - for medicinal products in the form of in-pharmacy preparations;d) the names of the medicines taken and their quantities, the degree of homeopathic dilutions or homeopathic substances taken, the number of doses, signatures of the persons who manufactured, packaged and checked the dosage form.The written control passport is filled out immediately after the manufacture of the medicinal product, indicating the medicinal products on Latin, in accordance with the sequence of technological operations.Written control passports are stored for two months from the date of manufacture of medicinal products.When making powders and suppositories, the total weight, quantity and weight of individual doses are indicated.The total suppository mass, concentration and volume (or mass) of the isotonic substance added to eye drops, solutions for injections and infusions must be indicated not only in the written control passports, but also on the back of the prescription for the drug.In the case of using concentrated solutions, the written control passport indicates their composition, concentration and volume taken.121. All calculations for the manufacture of a medicinal product are made before the manufacture of the medicinal product and are recorded in the written control passport.If the medicinal product contains narcotic drugs, psychotropic, poisonous and potent substances, as well as other drugs subject to subject-quantitative recording, their quantity is indicated on the back of the prescription.122. If medicinal products are manufactured and dispensed by the same person, a written control passport is filled out during the manufacturing process of the medicinal product.123. Manufactured medicinal products, recipes and requirements according to which the medicinal products are manufactured, completed written control passports are submitted for verification to the pharmacist who performs control functions in the manufacture and dispensing of medicinal products.Control consists of checking the compliance of the entries in the written control passport with the prescriptions or requirements, and the correctness of the calculations made.If a pharmacist-analyst has carried out full chemical quality control of the manufactured medicinal product, then the chemical analysis number and the signature of the pharmacist-analyst are affixed to the written control passport.Survey control124. Survey control is carried out selectively and is carried out after the pharmacist (pharmacist) has prepared no more than five dosage forms.When conducting survey control, the pharmacist performing the control function names the first drug included in the medicinal product, and in medicinal products of complex composition, its quantity is also indicated, after which the pharmacist (pharmacist) indicates all other medicinal products used and their quantities. When using concentrated solutions, the pharmacist (pharmacist) also indicates their composition and concentration.Organoleptic control125. Organoleptic control is a mandatory type of control and consists of checking the medicinal product by appearance, smell, uniformity of mixing, and the absence of mechanical inclusions in liquid dosage forms. Dosage forms intended for children are selectively tested for taste.The uniformity of powders, homeopathic triturations, oils, syrups, ointments, suppositories is checked selectively by each pharmacist (pharmacist) during the working day, taking into account all types of manufactured dosage forms.The results of organoleptic control are registered in the journal for recording the results of organoleptic, physical and chemical control of medicinal products manufactured according to prescriptions for medicinal products, the requirements of medical organizations and in the form of in-pharmacy preparations, concentrated solutions, triturations, ethyl alcohol and packaging of medicinal products.Physical control126. Physical control consists of checking the total mass or volume of the medicinal product, the number and weight of individual doses (at least three doses) included in the medicinal product, the number of granules in one gram of homeopathic granules, and the disintegration of homeopathic granules.As part of physical control, the quality of closure of the manufactured medicinal product is also checked.Medicines manufactured according to prescriptions and requirements are subject to physical control selectively during the working day, taking into account all types of manufactured dosage forms, but not less than 3% of their quantity per day.Medicines manufactured in the form of in-pharmacy preparations are subject to physical control in the amount of at least three packages of each series (including packaging of industrial products and homeopathic medicines). Physical control is mandatory for medications intended for use in children under 1 year of age, containing narcotic drugs, psychotropic and potent substances, medications requiring sterilization, suppositories, injection homeopathic solutions, homeopathic matrix tinctures.127. Sugar granules, as an excipient, are subject to mandatory control of the number of granules in one gram when supplied to a pharmacy organization or an individual entrepreneur.1 gram of granules is weighed with an accuracy of 0.01 grams and the number of granules is counted. At least two determinations are made.Homeopathic granules, manufactured in the form of an in-pharmacy preparation, are subject to disintegration control selectively, but not less than 10% of the total number of batches produced per month.10 granules are placed in a conical flask with a capacity of 100 ml, 50 ml of purified water at a temperature of 37 ° C + - 2 ° C is added. The flask swings slowly 1-2 times per second. At least three determinations are made.The granules should disintegrate within no more than 5 minutes.128. The results of physical control are recorded in the journal for recording the results of organoleptic, physical and chemical control of medicinal products manufactured according to prescriptions, requirements and in the form of in-pharmacy preparations, concentrated solutions, triturations, ethyl alcohol and packaging of medicinal products.Chemical control129. Chemical control consists of assessing the quality of manufacturing of medicinal products according to the following indicators:qualitative analysis: authenticity of medicines;quantitative analysis: quantitative determination of drugs.To carry out chemical control, a special workplace is equipped, equipped with the necessary equipment, instruments and reagents, provided with documents in the field of quality control and reference literature.The results of the qualitative analysis are registered in the logbook for registering the results of organoleptic, physical and chemical control of medicinal products manufactured according to prescriptions, requirements and in the form of in-pharmacy preparations, concentrated solutions, triturations, ethyl alcohol and packaging of medicines, as well as in the logbook for recording the results of control of medicines at authenticity.130. Qualitative analysis in mandatory are exposed to:a) purified water and water for injection daily from each cylinder, and when water is supplied through a pipeline - at each workplace for the absence of chlorides, sulfates and calcium salts. Water intended for the preparation of sterile solutions must also be tested for the absence of reducing substances, ammonium salts and carbon dioxide;b) all medicines and concentrated solutions (including homeopathic matrix tinctures, homeopathic triturations of the first decimal dilution, homeopathic solutions of the first decimal dilution) coming from the storage premises to the premises for the manufacture of medicinal products;c) medicines received by a pharmacy organization or an individual entrepreneur in case of doubt about their quality;d) concentrated solutions, liquid medicines in a burette unit and in rods with pipettes located in the premises for the production of medicines, when they are filled;e) packaged industrial medicinal products;f) homeopathic medicines in the form of in-pharmacy preparations. The quality of a medicinal product is assessed by its excipients.Purified water and water for injection must undergo quarterly full quality and quantitative analysis. 131. When conducting chemical control of purified water and water for injection, the log for recording the results of control of purified water and water for injection must indicate:a) date of receipt (distillation) of water;b) date of water control;c) number of the chemical analysis performed;d) number of the cylinder or burette from which the water was taken for analysis;e) results of control for the absence of impurities;f) pH indicators;g) conclusion on the results of water analysis (satisfied/dissatisfied);h) signature of the person who conducted the analysis.The journal for recording the results of control of purified water and water for injection must be numbered, laced and sealed with the signature of the head of the institution and the seal of a higher organization.132. Qualitative analysis should be carried out selectively on drugs of various dosage forms prepared by a pharmacist (pharmacist) during the working day, but not less than 10% of the total number of drugs produced by each pharmacist, except for homeopathic ones.Homeopathic medicines in the form of in-pharmacy preparations are prepared under the supervision of a pharmacist-analyst or pharmacist-technologist. In triturations of homeopathic and homeopathic granules, the quality of the medicinal product is additionally assessed by the excipients.133. When carrying out chemical control of the authenticity of medicines in a burette unit, rods and rods with pipettes, the following information must be indicated in the logbook for registering the results of monitoring of medicines for authenticity:a) date of filling of the burette unit, rod;b) serial number of chemical analysis;c) name of the medicinal product;d) batch number or analysis number of the medicinal product of the medicinal product manufacturer;e) number of the bar to be filled;f) analyte (ion);g) control results on a “plus” or “minus” scale;h) signatures of the persons who completed and verified the completion.The journal of the results of control of medicines for authenticity must be numbered, laced and sealed with the signature of the head of the pharmacy organization (individual entrepreneur) and a seal (if there is a seal).134. The following are subject to mandatory qualitative and quantitative analysis (full chemical control):a) all solutions for injections and infusions before sterilization, including determination of pH values, isotonic and stabilizing substances. Solutions for injections and infusions after sterilization are checked for pH value, authenticity and quantitative content active ingredients; Stabilizers after sterilization are checked only in the case provided for in the quality control document.b) sterile solutions for external use (ophthalmic solutions for irrigation, solutions for the treatment of burn surfaces and open wounds, for intravaginal administration and other sterile solutions);c) eye drops and ointments containing narcotic drugs, psychotropic, potent substances. When analyzing eye drops, the content of isotonic and stabilizing substances in them is determined before sterilization;d) all dosage forms intended for the treatment of newborns and children under 1 year of age;e) solutions of atropine sulfate and hydrochloric acid (for internal use), solutions of silver nitrate;f) all concentrated solutions, triturations, except homeopathic triturations;g) medicines in the form of in-pharmacy preparations of each series, except for homeopathic medicines;h) stabilizers used in the manufacture of solutions for injections and infusions, buffer solutions used in the manufacture of eye drops;i) the concentration of ethyl alcohol during dilution, as well as in case of doubts about the quality of ethyl alcohol when it is delivered to a pharmacy organization or to an individual entrepreneur;j) injection homeopathic solutions;k) dosage forms manufactured according to prescriptions and requirements, in an amount of at least three dosage forms when working in one shift, taking into account different types of dosage forms. Particular attention should be paid to dosage forms for children used in ophthalmic practice, containing narcotic and toxic drugs, solutions for therapeutic enemas.Requirements for quality control of sterile solutions135. The production and quality control of sterile solutions are carried out in accordance with these Rules, the requirements of the State Pharmacopoeia of the XII edition or other document in the field of quality control.136. Microbiological control of solutions, with the exception of individually manufactured solutions, for sterility and testing for pyrogenicity or bacterial endotoxins of solutions for injections and infusions is carried out in accordance with the requirements of the State Pharmacopoeia of the XII edition or other document in the field of quality control.137. Before and after sterilization of sterile solutions, they are checked for mechanical inclusions.Mechanical inclusions are foreign mobile insoluble substances, in addition to gas bubbles, that are accidentally present in solutions of drugs.At the same time, the volume of solutions in containers and the quality of their closure must be checked.138. During the manufacturing process, sterile solutions must be subjected to primary and secondary control for mechanical inclusions.Primary control is carried out after filtering and packaging the prepared solution.If mechanical inclusions are detected, the solution is re-filtered, inspected again, sealed, labeled and sterilized.Solutions prepared aseptically are inspected once after packaging or sterilizing filtration.100% of containers with solutions are subject to primary and secondary control.139. The control of solutions for the absence of mechanical inclusions is carried out by a pharmacist-technologist in compliance with the conditions and control techniques.To view containers, there must be a specially equipped workplace, protected from direct sunlight; the use of a black and white screen and special devices is allowed.Depending on the volume of the container, from one to five pieces are viewed at a time.Control during the dispensing of drugs140. When dispensing medicinal products, all manufactured medicinal products are subject to control, within the framework of which compliance is checked:a) packaging of a medicinal product with physical and chemical properties of the medicinal products included in it;b) the doses of narcotic drugs, psychotropic, and potent substances indicated in the prescription or requirement, depending on the age of the patient;c) prescription details, requirements for information indicated on the packaging of the manufactured medicinal product;d) labeling of the medicinal product to the requirements specified in Appendix No. 1 to these Rules.If one of the specified inconsistencies is detected, the manufactured medicinal product is not subject to release.VIII. Rules for dispensing manufactured medicinal products141. The rules for the release of medicines for medical use by pharmacy organizations and individual entrepreneurs holding a license for pharmaceutical activities apply to the dispensing of manufactured medicinal products.<5>. 142. Labeling of dispensed medicinal products must comply with the requirements established in Appendix No. 1 to these Rules. _____________ <5>Part 2 of Article 55 of the Federal Law of April 12, 2010 N 61-FZ “On the Circulation of Medicines” (Collection of Legislation of the Russian Federation, 2010, N 16, Art. 1815; N 31, Art. 4161; 2013, N 48, Art. 6165; 2014, N 52, Art. 7540). __________________ Appendix No. 1 to the Rules for the manufacture and dispensing of medicinal productsdrugs for medical use in pharmaciesorganizations, individual entrepreneurs,having a pharmaceutical licenseactivities approved by order of the Ministryhealthcare of the Russian Federationdated October 26, 2015 N 751nRequirements for labeling of manufactured medicinal productspreparations for medical use1. All medications manufactured and packaged in a pharmacy organization or an individual entrepreneur with a license for pharmaceutical activities are issued with appropriate labels.2. Labels for registration of medicinal products, depending on the method of their use, are divided into:a) labels for drugs for internal use with the inscription “Internal”;b) labels for external medicinal products with the inscription “External”;c) labels for drugs for parenteral administration with the inscription “For injection”, “For infusion”;d) labels for eye medications with the words “Eye drops”, “Eye ointment”, “Irrigation solutions”;e) for homeopathic medicines with the inscription “Homeopathic” or “Homeopathic medicine”.3. The labels have the following signal colors in the form of a field on a white background:a) for internal use - green;b) for external use - orange color;c) for eye drops, eye ointments, irrigation solutions - pink;d) for injections and infusions - blue.4. All labels for the design of manufactured medicinal products must contain warning notices corresponding to each dosage form:a) for mixtures - “Store in a cool place, protected from light”, “Shake before use”;b) for ointments, eye ointments and eye drops - “Store in a cool place protected from light”, for homeopathic ointments “Store in a place protected from light at a temperature of 5 to 15 ° C”;c) for drops for internal use - “Store in a place protected from light”; for homeopathic drops - “Store in a place protected from light, at a temperature not exceeding 25°C”; for homeopathic granules - “Store in a dry place, protected from light, at a temperature not exceeding 25°C”;d) for injections and infusions - “Sterile”.5. All labels must contain the warning “Keep out of reach of children.”6. Warning notices affixed to manufactured medicinal products must have the following text and signal colors:a) “Shake before use” - green font on a white background;b) “Store away from light” - white font on a blue background;c) “Store in a cool place” - white font on a blue background;d) “Children’s” - white font on a green background;e) “For newborns” - white font on a green background;f) “Handle with care” - red font on a white background;g) “Cardiac” - white font on an orange background;h) “Keep away from fire” - white font on a red background.7. For medicinal products that require special conditions of storage, handling and use, additional warning notices may be printed or affixed to the labels.8. The dimensions of the labels are determined in accordance with the size of the container or other packaging in which the manufactured medicinal products are dispensed.9. Medicinal products, depending on the dosage form and purpose, should be labeled with the appropriate types of labels: “Mixture”, “Drops”, “Homeopathic oral drops”, “Powders”, “Homeopathic granules” “Eye drops”, “Eye ointment” , “Ointment”, “Homeopathic ointment”, “Homeopathic opodeldok”, “Homeopathic rectal suppositories”, “Homeopathic oil”, “External”, “For injection”, “Nose drops”, etc.10. Labels for medicinal products manufactured for the public must indicate:b) the location of the pharmacy organization or the place of pharmaceutical activity of an individual entrepreneur;c) prescription number (assigned at the pharmacy);d) Full name patient;e) name or composition of the medicinal product;f) method of use of the drug (internal, external, injection), type of dosage form (eye drops, ointment, etc.);g) a detailed description of the method of use (for mixtures: “__________ spoon ______ times a day _______ food”; for drops for internal use: “__________ drops _________ times a day ________ food”; for powders: “_________ powder ______ times a day ______ food"; for eye drops: "_________ drops _______ once a day in _______ eyes"; for other dosage forms used externally, a space must be left to indicate the method of use, which must be filled in by hand or stamped. On drug labels drugs for injections and infusions, there must be a place for writing the composition of the drug and indicating the method of its use or administration);h) date of manufacture of the medicinal product;j) price of the medicinal product;k) warning “Keep out of reach of children.”11. All labels for the registration of medicinal products manufactured for medical organizations must indicate:a) the name of the medical organization and its structural unit (if necessary);b) name of the pharmacy organization / Full name. an individual entrepreneur with a license for pharmaceutical activities;c) location of the pharmacy organization / pharmaceutical activity of an individual entrepreneur holding a license for pharmaceutical activity;d) Full name the patient for whom the medicinal product is individually prepared (if necessary);e) method of use of the drug (internal, external, injection), type of dosage form (eye drops, ointment, etc.);f) date of manufacture of the medicinal product;g) shelf life of the medicinal product (“Expired until _____”);h) signatures of the person who manufactured, checked and dispensed the medicinal product (“Manufactured ______, checked ______, released _________”);i) number of the analysis of the medicinal product;j) composition of the medicinal product (empty space is provided to indicate the composition). The labels of drugs for injections and infusions must indicate the method of administration of the drug: “Intravenous”, “Intravenous (drip)”, “Intramuscular”.12. The text of the labels must be printed in Russian. The composition of the medicinal product is written by hand or stamped. The names of medicinal products that are often found in the recipe, or manufactured in the form of an in-pharmacy preparation, can be printed in a typographical manner.13. Labels for homeopathic medicines manufactured as intrapharmacy preparations according to frequently used prescriptions must indicate:a) name of the pharmacy organization, full name. an individual entrepreneur with a license for pharmaceutical activities;b) the address of the location of the pharmacy organization or the place of implementation of pharmaceutical activities by an individual entrepreneur;c) the name of the monocomponent homeopathic medicinal product in Russian (transliteration);name of the complex homeopathic medicinal product in Russian;d) composition for monocomponent and complex homeopathic medicines (active components - in Latin, auxiliary components - in Russian); e) mass; f) method of application;g) type of dosage form (homeopathic granules, homeopathic drops, homeopathic ointment, homeopathic trituration, etc.);h) date of manufacture of the homeopathic medicinal product;i) expiration date of the medicinal product (“Expired until _____”); j) series; k) price of the medicinal product;l) barcode (if available);m) warning “Keep out of reach of children”, storage conditions. _________________ ____________ Appendices No. 2-15 to the Rules are not provided. See the official Internet portal of legal information http://www.pravo.gov.ru. __________________

In order to implement in the system of the Ministry of Internal Affairs of Russia the Decree of the Government of the Russian Federation of August 5, 2008 N 583 “On the introduction of new systems of remuneration for employees of federal budgetary institutions and federal state bodies, as well as civilian personnel of military units, institutions and divisions of federal executive authorities, in which the law provides for military and equivalent service, the remuneration of which is currently carried out on the basis of the Unified tariff schedule for remuneration of employees of federal government institutions" 1 - I order:

1. Establish for civilian personnel of military units 2, institutions and divisions of the Russian Ministry of Internal Affairs, whose remuneration is currently carried out on the basis of the Unified tariff schedule for remuneration of employees of federal government institutions, new remuneration systems in accordance with the Resolution.

2. Approve:

2.1. Salaries (official salaries, tariff rates) for civilian personnel of military units, institutions and divisions of the Russian Ministry of Internal Affairs (Appendix No. 1).

2.2. The procedure for determining the official salaries of heads of military units, institutions and divisions of the Russian Ministry of Internal Affairs, their deputies, and chief accountants (Appendix No. 2).

2.3. Conditions, amounts and procedure for making compensation payments to civilian personnel of military units, institutions and divisions of the Russian Ministry of Internal Affairs system (Appendix No. 3).

2.4. Conditions, amounts and procedure for making incentive payments to civilian personnel of military units, institutions and divisions of the Russian Ministry of Internal Affairs (Appendix No. 4).

2.5. The procedure for the formation and use of the wage fund for civilian personnel of military units, institutions and divisions of the Russian Ministry of Internal Affairs (Appendix No. 5).

3. Commander-in-Chief of the Internal Troops of the Ministry of Internal Affairs of Russia, heads of units of the central apparatus of the Ministry of Internal Affairs of Russia, units directly subordinate to the Ministry of Internal Affairs of Russia, main directorates of the Ministry of Internal Affairs of Russia in federal districts, ministers of internal affairs, heads of main departments, departments of internal affairs in the constituent entities of the Russian Federation, directorates (departments) internal affairs in railway, water and air transport, departments (departments) of internal affairs in closed administrative-territorial entities, at particularly important and sensitive facilities, logistics departments, educational and research institutions, healthcare institutions and other institutions of the Ministry of Internal Affairs of Russia , commanders of troops of operational-territorial formations, commanders of formations and military units, military chiefs educational institutions higher vocational education, institutions of internal troops of the Ministry of Internal Affairs of Russia:

3.1. Organize work to introduce new wage systems for civilian personnel of subordinate military units, institutions and divisions, with the involvement of trade union bodies (if any).

3.2. Transfer civilian personnel of subordinate military units, institutions and divisions to new remuneration systems, taking into account the recommendations of the Ministry of Health and Social Development of Russia on the conclusion of an employment contract and its approximate form.

4. Allow the leaders (commanders, chiefs) of military units, institutions and divisions of the Russian Ministry of Internal Affairs, whose constituent documents provide for the receipt of funds from income-generating activities, to independently determine the amount and procedure for allocating these funds to make incentive payments to the civilian personnel of these military units and institutions and divisions in accordance with the general permit (permit), as well as estimates of income and expenses for income-generating activities, approved in the prescribed manner.

7. Control over the implementation of this order is entrusted to the Deputy Ministers in the areas of activity supervised.

Acting Minister

Lieutenant General of Police

M. Sukhodolsky

2 In this order, military units are understood as: command and control bodies, formations, military educational institutions of higher professional education, military units, institutions of internal troops of the Ministry of Internal Affairs of Russia.

Appendix No. 1

Salaries (official salaries, tariff rates) for civilian personnel of military units, institutions and divisions of the Russian Ministry of Internal Affairs system

The salaries (official salaries, tariff rates) of civilian personnel of military units, institutions and divisions of the Russian Ministry of Internal Affairs system are established taking into account professional qualification groups, approved by the Ministry of Health and Social Development of Russia.

1. Official salaries for professional qualification groups of industry-wide positions of managers, specialists and employees 1.

1.1. Professional qualification group "General industry positions of first-level employees"

Qualification levels Position name Position salaries (RUB)

1.2. Professional qualification group "General industry positions of second-level employees"

1.3. Professional qualification group "General industry positions of third-level employees"

1.4. Professional qualification group "General industry positions of fourth level employees"

2. Salaries by professional qualification groups of general industry professions of workers 4

2.1. Professional qualification group "General industry professions of first-level workers"

2.2. Professional qualification group "General industry professions of second-level workers"

3. Official salaries for professional qualification groups of paramilitary and security guard positions 5

3.1. Professional qualification group of the first level

3.2. Professional qualification group of the second level

4. Official salaries for professional qualification groups of positions of medical and pharmaceutical workers 6

4.1. Professional qualification group "Medical and pharmaceutical personnel of the first level"

4.2. Professional qualification group "Nurse medical and pharmaceutical personnel"

4.3. Professional qualification group "Doctors and pharmacists"

4.4. Professional qualification group "Heads of structural units of institutions with higher medical and pharmaceutical education (specialist doctor, pharmacist)"

5. Official salaries for professional qualification groups of positions of workers employed in the field of healthcare and social services 7

5.1. Professional qualification group "Positions of second-level specialists providing social services"

5.2. Professional qualification group "Positions of third-level specialists in healthcare institutions and providing social services"

5.3. Professional qualification group "Positions of managers in healthcare institutions and those providing social services."

6. Official salaries for professional qualification groups of positions in culture, art and cinematography 8

6.1. Professional qualification group "Positions of technical performers and supporting artists"

6.2. Professional qualification group "Positions of mid-level workers in culture, art and cinematography"

6.3. Professional qualification group "Positions of leading level workers in culture, art and cinematography"

6.4. Professional qualification group "Positions of management staff of cultural, art and cinematographic institutions"

7. Salaries by professional qualification groups of workers in culture, art and cinematography 9

7.1. Professional qualification group "Professions of culture, art and cinematography workers of the first level"

7.2. Professional qualification group "Professions of culture, art and cinematography workers of the second level"

8. Official salaries for professional qualification groups of positions of education workers (except for positions of employees of higher and additional professional education) 10

8.1. Professional qualification group of positions for first-level educational and support staff

8.2. Professional qualification group of positions for second-level educational and support staff

8.3. Professional qualification group of teaching positions

8.4. Professional qualification group of positions of heads of structural divisions

9. Official salaries for professional qualification groups of positions of employees of higher and additional professional education 11

9.1. Professional qualification group of positions of administrative, economic and educational support personnel

9.2. Professional qualification group of positions of teaching staff and heads of structural divisions

10. Official salaries for professional qualification groups of positions of workers in physical culture and sports 12

10.1. Professional qualification group of positions for physical education and sports workers of the first level

10.2. Professional qualification group of positions for physical culture and sports workers of the second level

10.3. Professional qualification group of positions for third-level physical education and sports workers

10.4. Professional qualification group of positions for physical education and sports workers of the fourth level

11. Official salaries for professional qualification groups of positions in the field of scientific research and development 13

11.1. Professional qualification group of positions of scientific and technical workers of the second level

11.2. Professional qualification group of positions of scientific and technical workers of the third level

11.3. Professional qualification group of positions of scientists and heads of structural divisions

12. Official salaries for professional qualification groups of positions of agricultural workers 15

12.1. Professional qualification group "Positions of second-level agricultural workers"

12.2. Professional qualification group "Positions of third level agricultural workers"

12.3. Professional qualification group "Positions of fourth level agricultural workers"

13. Official salaries for professional qualification groups of positions of television (radio broadcasting) workers 16

13.1. Professional qualification group "Positions of television (radio broadcasting) workers of the first level"

13.2. Professional qualification group "Positions of television (radio broadcasting) workers of the second level"

13.3. Professional qualification group "Positions of television (radio broadcasting) workers of the third level"

13.4. Professional qualification group "Positions of television (radio broadcasting) workers of the fourth level"

14. Official salaries for professional qualification groups of positions of printed media workers mass media 17

14.1. Professional qualification group "Positions of first-level print media workers"

14.2. Professional qualification group "Positions of second-level print media workers"

14.3. Professional qualification group "Positions of third-level print media workers"

14.4. Professional qualification group "Positions of fourth level print media workers"

List of important (particularly important) and responsible (particularly responsible) work, for the performance of which salaries are established for civilian personnel of military units, institutions and divisions of the Russian Ministry of Internal Affairs system

at the highest qualification level of the relevant

professional qualification group

1.1. All types of repairs, assembly, adjustment and testing on stands of complex imported high-class automotive equipment with computer diagnostics and electronic equipment.

1.2. Repair and Maintenance rotary piston engines (single copies) installed on operational machines, replacement of intersectional gaskets that ensure compression of the rotor sections and penetration of coolant into the combustion chamber, replacement of the lubricator, replacement and repair of the heat exchange device located inside the engine, checking the correct installation of sensors that control pulses ignition systems.

1.3. Repair, assembly and bench testing of automatic transmissions, torque converters and power units of imported vehicles. Installation and repair work special means alarms. Testing prototypes of spare parts for imported automotive equipment, introducing changes in the design of vehicles and their electrical circuits.

1.4. Repair of foreign-made diesel engines, units of new domestic and foreign brands and their testing, adjustment, calibration and testing on imported and unique domestic equipment of fuel equipment with electronic injection and turbocharging.

1.5. Diagnostics and regulation of rotary piston engines, diesel engines with electronic fuel injection, imported turbocharging.

1.6. Repair and maintenance of fuel equipment for rotary piston engines and imported vehicles, repair and maintenance of contactless digital systems ignition with control units, switches using special equipment for monitoring and diagnostics of rotary piston engines.

1.7. Repair, calibration, testing of imported diagnostic equipment to check electrical equipment systems, ignition, traction, economic and braking qualities of operational vehicles.

1.8. Repair of all types and categories of complexity of car bodies of imported and domestic production, both passenger cars and trucks, using imported equipment, using advanced technologies on semi-automatic welding machines in various shielding gas environments.

1.9. Manufacture of complex parts and components of car and truck bodies by hand.

1.10.High-quality painting and finishing of passenger vehicle body surfaces using various paints and varnishing.

2. Work on assembling and testing explosive devices and ammunition.

2.1. Dismantling, dismantling and subsequent assembly of samples of foreign and particularly complex domestic ammunition and explosive devices.

2.2. Processing of parts of various configurations containing explosives and gunpowder using metal-cutting equipment.

2.3. Conducting comprehensive tests of ammunition and explosive devices.

2.4. Disarming and neutralizing explosive devices of complex configurations, as well as unknown foreign models.

2.5. Debugging and adjustment of complex and particularly complex systems of fuses and explosive devices with adjustment of parts during the assembly process, debugging and final assembly of shots.

2.6. Conducting the technological process of melting and pouring explosive devices.

2.7. Installation of complex integrated test circuits using a computer.

3. Optical work.

3.1. Manufacturing of highly precise (up to fractions of a micron) mechanical parts, with thicknesses and edges exceeding the requirements established by the industry standard of the optical industry, and assemblies for unique optical-mechanical and optical-electronic systems of special equipment with individual fitting and adjustment, requiring high professional skills (including including engineering).

3.2. Application of special coatings (up to 25 layers) on optical parts not provided for by developments in industry guidelines.

3.3. Assembly, adjustment and fine-tuning of unique optical-mechanical and optical-electronic systems of special equipment that have no foreign or domestic analogues.

3.4. Installation, joint adjustment and adjustment of complexes (systems) of special equipment that have no analogues, using computer technology, video and television equipment.

3.5. Repair of complex imported duplicating, photo, film, television and video equipment in the absence of circuit diagrams and design documentation, as well as repair of special equipment systems, production of three- and multi-curvature individual axisymmetric corneal contact lenses of various designs, production of scleral, “cosmetic”, spherotoric, central-toric , biotoric, keratoconus and other lenses for vision correction in accordance with the doctor’s prescription, production of glasses with isoconic or spheroprismatic lenses, production of glass matrices and punches for flammable pressing of contact lenses from various polymers on special equipment using special equipment.

4. Installation and adjustment work.

4.4. Installation, assembly, adjustment, testing and delivery of particularly complex and critical components and products, special equipment.

4.5. Installation and processing of highly complex circuits for radio devices and prototypes.

4.6. Setting up and testing experimental and experimental receiving, transmitting, television, sound recording and other radio devices.

4.7. Installation, adjustment, repair of communication systems on existing high-capacity cables.

4.8. Electrical measurements using complex instrumentation on existing main cables, ensuring a special regime.

5. Control and measuring work.

5.1. Inspection and acceptance of particularly critical materials, parts, assemblies and finished special equipment of all types using sophisticated instrumentation, special and universal tools.

5.2. Verification and adjustment of complex and especially critical control and measuring instruments operating using optical-mechanical and hydraulic systems.

5.3. Participation in the study of defects identified during inspection and testing of special equipment products and in the development of measures to eliminate them.

6. Mechanical processing.

6.1. Mechanical processing of particularly complex and critical expensive components and parts of products, special equipment and special tools, including 0-2 accuracy classes, having several mating curved and cylindrical surfaces, places that are difficult to access for processing and measuring using special cutting tools and optical devices , on metal-cutting machines of various types and models, as well as using the method of combined plasma and mechanical processing.

6.2. Carrying out complex cutting of high-precision teeth of various profiles and modules, cutting all kinds of threads and spirals on universal and optical dividing heads with performing the necessary calculations.

7. Plumbing and assembly work.

7.1. Assembly, adjustment, testing and delivery of particularly complex and critical parts and components of products, special equipment, production of special tools.

7.2. Repair, adjustment and adjustment of parts and products without the use of specialized measuring systems, opening of fireproof cabinets and internal drawers of safes of imported and domestic production with various types locks

7.3. Production and repair of a set of locks of complex profiles with the production of especially complex keys for fireproof cabinets and safes of various systems.

7.4. Opening and repairing cabinets and safes of complex systems, making keys and parts for them.

8. Semiconductor production.

8.1. Carrying out complex technological processes sputtering, diffusion, etching to obtain semiconductor products with subsequent use in special equipment.

8.2. Testing of experimental and particularly complex high-voltage and high-frequency products and devices.

8.3. Welding of devices with complex alignment of welded units within tight tolerances; welding of parts made of heat-resistant steels intended for testing under vibration loads.

8.4. Grinding, polishing of piezoquartz plates of particular complexity with tolerance fields of 1-4 qualifications, production of prototypes and experimental samples.

8.5. Production of particularly complex photomasks, emulsion and metallized intermediate originals, determination and correction of the photochemical and photolithographic process to obtain fine-structured negative, slide and positive images in compliance geometric shapes within a given accuracy class.

8.6. Assembly of the most critical components of microcircuits.

9. Welding work.

9.1. Arc, plasma, gas and electric welding of particularly complex, miniature and critical structures, parts, product assemblies, special equipment made of various steels, non-ferrous metals and alloys for work under dynamic and vibration loads.

9.2. Welding of experimental structures made of metals and alloys with limited weldability, as well as titanium and titanium alloys.

9.3. Welding of particularly critical structures in block design in all spatial positions of the weld.

10. Woodworking.

10.1. Manufacturing, cleaning of parts, assemblies and products according to individual projects, lining with sliced ​​veneer from valuable wood species, performing camouflage work according to complex drawings, samples and sketches.

10.2. Manufacturing, installation and restoration repair of particularly complex shaped and patterned products (templates) from hard and valuable wood.

10.3. Manufacturing, assembly of parts and units of special equipment.

10.4. Installation and adjustment of equipment for woodworking enterprises.

10.6. Inlay of highly artistic and unique wood products, intarsia.

10.7. Burning out particularly complex designs on wood products with an electric needle.

11. Metal coating, painting.

11.1. Galvanic coatings of all types of critical and particularly complex products and parts, special equipment with camouflage for imported coatings of products.

11.2. High-quality painting and finishing of surfaces of products and special equipment using various paints, varnishing and camouflage.

11.3. Experimental finishing of products and surfaces with the introduction of new dyes and synthetic materials.

12. Forging and pressing production.

12.1. Manufacturing of particularly complex, thin-walled parts of products, special equipment from various steels, non-ferrous metals and plastics, bringing the alloy to the required chemical composition.

12.2. Pressing on hydraulic presses products of particularly complex configurations with pressing in a large number of pre-processed thin and complex fittings using unique molds.

12.3. Pressing products from various press materials on hydraulic presses.

12.4. Chemical-thermal and thermal treatment of particularly complex, unique parts and assemblies made of alloyed, high-alloy, corrosion-resistant and special-purpose steels.

13. Commissioning, repair, installation and design work.

13.1. Repair, installation, dismantling, testing and adjustment of particularly complex, unique equipment, experimental and pilot equipment used in the manufacture of special equipment, according to 5-6 accuracy grades using special cutting and measuring tools and devices.

13.2. Adjustment of mechanical and electrical devices, including multi-operational machines with program controlled, for processing parts that require a large number of rearrangements and combined fastening.

13.3. Adjustment and adjustment of processing complexes of machine tools and machine systems with manipulators and program control.

13.4. Repair, adjustment, testing and commissioning of complex and particularly complex products and circuits of automation, telemechanics, communications, information processing, electronic-mechanical products and circuits, as well as special equipment equipped with information and measuring systems, microprocessors, computer equipment without the use specialized measuring systems and testing equipment.

13.5. Installation, adjustment, repair of communication and air conditioning systems, lifting equipment, ventilation, air conditioning, compressor units, refrigeration machines, sanitary systems.

13.6. Artwork, design; development of a design project for exposition equipment, working drawings of exhibit mounting units, preparation of exposition mounting sheets, production of individual mounting units and parts, installation of the exposition.

13.7. Production of artistic binding covers from leather, velvet and silk with selection of materials.

13.8. Adjustment and printing on two-, four- and six-color full-format offset machines.

13.9. Performing particularly complex operations on sewing special products from various materials using machines or manually.

13.10. Installation, maintenance, repair and adjustment of highly complex, unique and experienced dental, laboratory, pharmacy, sterilized and surgical equipment.

13.11. Installation, repair, maintenance, testing, adjustment and adjustment of particularly complex, unique and experienced optical and endoscopic instruments, visual inspection of instruments, grinding of optical parts, polishing, finishing of the surfaces of prisms and lenses, determining the degree of wear of parts and assemblies.

13.12. Installation, maintenance, repair, adjustment and control testing of particularly complex unique and experimental X-ray equipment, comprehensive testing of X-ray equipment, obtaining control cygrams and antigraphs and analyzing them, drawing up complex electrical connection diagrams for X-ray installations, test diagrams and connection diagrams for X-ray equipment units, adjustment of optics of the visual channel and film camera, testing of repaired equipment in X-ray rooms, X-ray radiation zones using spherical kilovoltmeters, fontomes, pulse generators of complex shapes.

13.13. Installation, repair, adjustment of particularly complex, experienced unique and experimental anesthesia-respiratory equipment, identification and elimination of malfunctions in the operation of serviced equipment, performance of debugging and finishing work.

13.14. Installation, repair, maintenance and adjustment of particularly complex, unique and experienced medical electrical and radio equipment, removal and analysis of tomograms and encephalograms, calculation of basic electrical parameters for the repair and adjustment of medical electronic devices and devices.

13.15. Identification and elimination of defects, causes and degree of wear of parts of particularly complex relay protection and automation equipment, repair of electronic equipment, identification of faults and performance of the most complex work on the repair of mechanical and electrical parts of relays, high-frequency protection units, instruments and apparatus, restoration of complex parts, installation panels of particularly complex protection, repair of all types of protection and automation devices of any complexity, work with electronic measuring equipment, oscilloscopes, high-frequency meters and generators, adjustment and repair of particularly complex testing equipment, assembly of complex circuits for special non-standard tests of relay protection and automation, application and maintenance of complex automation devices under the guidance of an engineer or foreman.

14. Driving cars.

14.1. Management of resuscitation vehicles (for actually going to the line to provide emergency medical care).

14.2. Driving emergency vehicles (while traveling to the line to provide emergency assistance).

14.3. Driving a car by a Class I driver during the time spent transporting students (children).

14.4. Driving a car by a Class I driver serving operational units of internal affairs bodies.

15. Cooking, culinary work.

15.1. Preparation of dishes and culinary processing of products requiring particularly complex culinary processing, as well as when the cook performs the duties of a production manager (chef), in the absence of such a position on the staff of the institution.

Note. In military units, institutions and divisions of the Russian Ministry of Internal Affairs system, lists of important and responsible work approved by other federal executive authorities may be used, provided that the relevant types of work are performed.

____________________

1 Professional qualification groups of industry-wide positions of managers, specialists and employees were approved by order of the Ministry of Health and Social Development of Russia dated May 29, 2008 N 247n “On approval of professional qualification groups of industry-wide positions of managers, specialists and employees” (registered with the Ministry of Justice of Russia on June 18, 2008, registration No. 11858).

2 The official salaries of deputy heads of the listed departments are set 10-20 percent below the official salary of the chief.

3 Except for cases where the position with the name “Chief” is an integral part of the position of the head or deputy head of the organization, or the performance of functions for the position of a specialist with the name “Chief” is assigned to the head or deputy head of the organization.

4 Professional qualification groups of industry-wide professions of workers were approved by order of the Ministry of Health and Social Development of Russia dated May 29, 2008 N 248n “On approval of professional qualification groups of industry-wide professions of workers” (registered with the Ministry of Justice of Russia on June 23, 2008, registration No. 11861).

5 Professional qualification groups of positions for paramilitary and guard security workers were approved by Order of the Ministry of Health and Social Development of Russia dated May 21, 2008 N 235n “On approval of professional qualification groups for positions of paramilitary and guard guard workers” (registered with the Ministry of Justice of Russia on June 6, 2008, registration N 11801) .

6 Professional qualification groups for positions of medical and pharmaceutical workers were approved by Order of the Ministry of Health and Social Development of Russia dated August 6, 2007 N 526 “On approval of professional qualification groups for positions of medical and pharmaceutical workers” (registered with the Ministry of Justice of Russia on September 27, 2007, registration No. 10190).

7 Professional qualification groups of positions of workers employed in the field of healthcare and the provision of social services were approved by order of the Ministry of Health and Social Development of Russia dated March 31, 2008 N 149n “On approval of professional qualification groups of positions of workers employed in the field of healthcare and provision of social services” (registered with the Ministry of Justice Russia April 9, 2008, registration N 11481).

8 Professional qualification groups of positions for workers in culture, art and cinematography were approved by order of the Ministry of Health and Social Development of Russia dated August 31, 2007 N 570 “On approval of professional qualification groups for positions in workers in culture, art and cinematography” (registered with the Ministry of Justice of Russia on October 1, 2007, registration N 10222).

9 Professional qualification groups of professions of workers in culture, art and cinematography were approved by order of the Ministry of Health and Social Development of Russia dated March 14, 2008 N 121n “On approval of professional qualification groups of professions of workers in culture, art and cinematography” (registered with the Ministry of Justice of Russia on April 3, 2008, registration N 11452).

10 Professional qualification groups of positions for educators (with the exception of positions for employees of higher and additional vocational education) were approved by Order of the Ministry of Health and Social Development of Russia dated May 5, 2008 N 216n “On approval of professional qualification groups of positions for educators” (registered with the Ministry of Justice of Russia on May 22, 2008 , registration N 11731).

11 Professional qualification groups of positions for workers of higher and additional vocational education were approved by order of the Ministry of Health and Social Development of Russia dated May 5, 2008 N 217n “On approval of professional qualification groups of positions for workers of higher and additional vocational education” (registered with the Ministry of Justice of Russia on May 22, 2008, registration No. 11725).

12 Professional qualification groups for positions in physical culture and sports workers were approved by Order of the Ministry of Health and Social Development of Russia dated May 12, 2008 N 225n “On approval of professional qualification groups for positions in physical culture and sports workers” (registered with the Ministry of Justice of Russia on May 28, 2008, registration No. 11764) .

13 Professional qualification groups of positions for workers in the field of scientific research and development were approved by order of the Ministry of Health and Social Development of Russia dated July 3, 2008 N 305n “On approval of professional qualification groups of positions for workers in the field of scientific research and development” (registered with the Ministry of Justice of Russia on July 18, 2008, registration N 12001).

14 With the exception of positions of heads of structural divisions assigned to qualification levels 3-5.

15 Professional qualification groups of positions for agricultural workers were approved by order of the Ministry of Health and Social Development of Russia dated July 17, 2008 N 339n “On approval of professional qualification groups of positions for agricultural workers” (registered with the Ministry of Justice of Russia on July 31, 2008, registration No. 12048).

16 Professional qualification groups of positions for television (radio broadcasting) workers were approved by order of the Ministry of Health and Social Development of Russia dated July 18, 2008 N 341n “On approval of professional qualification groups of positions for television (radio broadcasting) workers” (registered with the Ministry of Justice of Russia on July 31, 2008, registration N 12047) .

17 Professional qualification groups of positions for workers in print media were approved by order of the Ministry of Health and Social Development of Russia dated July 18, 2008 N 342n “On approval of professional qualification groups for positions for workers in print media” (registered with the Ministry of Justice of Russia on July 31, 2008, registration N 12046) .

Appendix No. 2

Appendix No. 3

Conditions, amounts and procedure for making compensation payments to civilian personnel of military units, institutions and divisions of the Russian Ministry of Internal Affairs system

Types of compensation payments to civilian personnel of military units, institutions and divisions of the Ministry of Internal Affairs of Russia 1 are established in accordance with the list of types of compensation payments approved by the Ministry of Health and Social Development of Russia.

Compensatory payments, the amounts and conditions for their implementation are established by collective agreements, agreements, local regulations in accordance with labor legislation and other regulatory legal acts containing labor law norms.

At the same time, the amount of compensation payments cannot be lower than the amount established in accordance with the law.

The following types of compensation payments are established for civilian personnel:

Workers engaged in heavy work, work with harmful and (or) dangerous and other special conditions labor;

For work in areas with special climatic conditions;

For work in conditions deviating from normal (when performing work of various qualifications, combining professions (positions), overtime work, at night and when performing work in other conditions deviating from normal);

For work with information constituting state secrets, their classification and declassification, as well as for work with ciphers.

Payments of a compensatory nature are established in addition to salaries (official salaries, tariff rates) 2, in the form of allowances, additional payments, unless otherwise established by legislative and regulatory legal acts of the Russian Federation.

Compensation payments to managers are established by a senior manager who has the right to appoint to the position.

1. Payments to civilian personnel engaged in heavy work, work with harmful and (or) dangerous and other special working conditions.

1.1. Civilian personnel engaged in work with difficult and harmful, especially difficult and especially harmful working conditions are provided with additional payments in the following amounts:

For work in difficult and harmful working conditions - up to 12 percent of the salary;

For work in particularly difficult and particularly harmful working conditions - up to 24 percent of the salary.

The procedure for assessing working conditions at workplaces during the certification of workplaces and applying lists of work with heavy and harmful, especially difficult and especially harmful working conditions, for which allowances and surcharges for working conditions can be established, as well as the size of these allowances and surcharges depending on the actual state of working conditions are determined in the prescribed manner on the basis of relevant regulatory legal acts and approved by order of the head (commander, chief) of a military unit, institution, unit of the Russian Ministry of Internal Affairs 3.

The manager is responsible for conducting certification of workplaces in order to develop and implement an action program to ensure safe working conditions and labor protection.

Specific amounts of additional payments are determined based on the results of certification of workplaces and assessment of working conditions in accordance with the lists of jobs with difficult and harmful, especially difficult and especially harmful working conditions and are approved by order of the manager.

1.2. Civilian personnel of temporary detention centers for suspects and accused persons, temporary detention centers for juvenile offenders, special detention centers, medical sobering-up centers, and detention centers for foreign citizens are paid a bonus of 10 percent of their salary.

1.3. Civilian personnel of healthcare institutions, in accordance with the lists of institutions, departments and positions, work in which entitles employees to increased wages due to hazardous to health and difficult working conditions, approved by separate orders of the Ministry of Internal Affairs of Russia, is established additional wages in the form of a salary supplement .

1.4. Civilian personnel engaged in heavy work, work with harmful and (or) dangerous and other special working conditions may be subject to other compensation payments provided for by the legislative and regulatory legal acts of the Russian Federation.

2. Payments for work in areas with special climatic conditions.

TO wages for civilian personnel of institutions stationed in the Far North, equivalent areas and other areas with unfavorable climatic or environmental conditions, including remote ones, coefficients are established (regional, for work in high mountain areas, for work in desert and arid areas) and paid percentage bonuses to wages in the amounts and manner established by federal laws and other regulatory legal acts of the Russian Federation for citizens working and living in the specified areas and localities.

Increased regional coefficients may be applied to the wages of civilian personnel within the limits of the coefficients established for the relevant territories. Expenses for these purposes are carried out strictly within the limits of funds allocated for wages.

3. Payments for work in conditions deviating from normal (when performing work of various qualifications, combining professions (positions), overtime, at night and when performing work in other conditions deviating from normal).

3.1. For night work, additional payment is made in the following amounts:

3.1.1. Workers of healthcare institutions, including drivers of ambulance vehicles, medical personnel medical sobering stations - at the rate of 50 percent of the hourly rate for each hour of work at night.

3.1.2. For field personnel of duty units and field personnel of resuscitation teams - at the rate of 100 percent of the hourly rate for each hour of work at night.

3.1.3. For other employees - at the rate of 35 percent of the hourly rate for each hour of work at night.

3.2. For work in conditions deviating from normal conditions workers are given salary bonuses.

3.2.1. For workers who are not released from their main work, for leading a team (unit) or other unit:

With up to 10 people - 15 percent;

With 10 people or more - 25 percent.

3.2.2. For drivers:

Cars with irregular working hours - 25 percent;

For vehicles with trailers - 20 percent;

Serving medical institutions - 20 percent;

Working in Moscow and St. Petersburg - 10 percent.

3.3. For teaching staff working in sanatoriums for children in need of long-term treatment, a bonus of 20 percent of their salary is established.

3.4. Civilian personnel are subject to other compensation payments provided for by the legislative and regulatory legal acts of the Russian Federation.

4. Allowances for working with information constituting state secrets, their classification and declassification, as well as for working with codes.

Civilian personnel admitted to state secrets on an ongoing basis are paid a monthly percentage increase in salary for work with information constituting state secrets, in accordance with Decree of the Government of the Russian Federation of September 18, 2006 N 573 “On the provision of social guarantees to citizens admitted to state secrets” state secrets on an ongoing basis, and employees of structural units for the protection of state secrets" 4.

Civilian personnel of structural units for the protection of state secrets are paid a monthly percentage increase in salary for length of service in the specified structural units in accordance with Decree of the Government of the Russian Federation of September 18, 2006 N 573.

4 Collection of Legislation of the Russian Federation, 2006, No. 39, Art. 4083.

Appendix No. 4

Conditions, amounts and procedure for making incentive payments to civilian personnel of military units, institutions and divisions of the Russian Ministry of Internal Affairs system

Incentive payments to civilian personnel of military units, institutions and divisions of the Ministry of Internal Affairs of Russia 1 are established in accordance with the list of types of incentive payments approved by the Ministry of Health and Social Development of Russia.

Types of incentive payments include:

Payments for intensity and high performance results;

Payments for the quality of work performed;

Payments for continuous work experience, length of service;

Bonus payments based on performance results.

Incentive payments:

Are established in relation to salaries (official salaries, tariff rates), unless otherwise established by regulatory legal acts of the Russian Federation;

They are carried out within the limits of the civilian personnel payroll fund.

The main indicators for assessing the labor efficiency of civilian personnel include:

Successful, conscientious and high-quality performance of professional and official duties;

Professionalism and efficiency in performing labor functions;

Application at work modern forms and methods of labor organization.

Specific incentive indicators for civilian personnel are established by collective agreements, agreements, and local regulations.

1. Payments for intensity and high performance results.

1.1. Civilian personnel are paid a monthly bonus for complexity, intensity, high achievements in work and a special work schedule 2.

1.1.1. The bonus is established within the limits of the civilian personnel wage fund and is not limited to the maximum amount.

1.1.2. The allowance is established by order of the head (commander, chief) of a military unit, institution, division of the Russian Ministry of Internal Affairs 3, indicating a specific amount for a certain period (no more than one year).

The main conditions for establishing a premium are:

Conscientious performance by the employee of his official (labor) duties;

The employee performs unforeseen, urgent, particularly important and responsible work;

The employee’s competence in making appropriate decisions.

The manager has the right to make decisions regarding subordinate employees to change the amount of the bonus before the expiration of the period for which it is established.

1.2. For employees who speak foreign languages ​​and use them in practical work on a daily basis, the decision of the manager may establish a bonus for knowledge of one language in the amount of 10 percent, for knowledge of two or more languages ​​- 15 percent of the salary (official salary, tariff rate) 4 .

1.3. Car drivers are paid a monthly bonus for the assigned qualification category in the following amounts: 2nd class drivers - 10 percent and 1st class drivers - 25 percent of the salary.

1.3.1. The qualification categories “second class car driver” and “first class car driver” can be assigned to car drivers who have undergone training or retraining according to unified programs and have a driver’s license with a mark giving the right to drive certain categories Vehicle(“B”, “C”, “D”, “E”) in accordance with Decree of the Government of the Russian Federation of December 15, 1999 N 1396 “On approval of the rules for passing qualification exams and issuing driver’s licenses” 5.

2. Payments for the quality of work performed.

2.1. Civilian personnel of educational institutions (except for educational institutions of higher and corresponding additional professional education) who have honorary titles of the USSR, the Russian Federation and the union republics that were part of the USSR, corresponding to the profile of the work performed or academic degree candidate of sciences in the profile of the work performed, an increase of 25 percent of the salary is established.

2.2. Civilian personnel of educational institutions (except for educational institutions of higher and corresponding additional professional education) who have an academic degree of Doctor of Science in the profile of the work performed are given a bonus of 50 percent of the salary.

2.3. Persons, including those admitted in accordance with the established procedure to medical activities, holding medical and pharmacist positions, including managers with an academic degree:

Candidate of Medical (Pharmaceutical, Biological, Chemical) Sciences, an increase of 25 percent of the salary is established;

Doctors of medical (pharmaceutical, biological, chemical) sciences, an increase of 50 percent of the salary is established.

2.4. Doctors who have honorary titles of the USSR, the Russian Federation and the union republics that were part of the USSR are given a salary bonus in the following amounts:

"Honored Doctor" - 25 percent;

"People's Doctor" - 50 percent.

The bonus for doctors who have the honorary titles “People’s Doctor” and “Honored Doctor” is paid only for their main work.

If an employee has two honorary titles, “People’s Doctor” and “Honored Doctor,” the bonus is paid on one of the grounds.

2.5. Scientific and pedagogical workers of educational institutions of higher professional education are provided with bonuses for the position of associate professor and the position of professor in the amounts determined by the legislative and regulatory legal acts of the Russian Federation.

2.6. Civilian personnel of educational institutions of higher professional education, corresponding additional professional education and scientific institutions holding full-time positions for which academic degrees are provided qualification requirements, bonuses are established for the academic degree of Candidate of Sciences or Doctor of Sciences in the amounts determined by the legislative and regulatory legal acts of the Russian Federation.

2.7. Employees of cultural and educational institutions, for honorary titles awarded in the prescribed manner, are given a salary bonus in the following amounts:

For the honorary title "Honored Artist", "Honored Worker of Culture", "Honored Artist" - 25 percent.

For the honorary title "People's Artist" - 50 percent.

2.8. Medical and pharmaceutical personnel (including heads of healthcare institutions, their deputies and chief nurses) who have a qualification category are given a salary bonus in the following amounts:

According to II qualification category- 20 per cent;

For qualification category I - 30 percent;

For the highest qualification category - 40 percent.

3. Payments for continuous experience work, length of service.

3.1. A monthly percentage bonus for continuous work (length of service) 6 in the system of the Ministry of Internal Affairs of Russia is paid to salaries in the following amounts:

from 1 to 2 years - 5 percent;

from 2 to 5 years - 10 percent;

from 5 to 10 years - 20 percent;

from 10 to 15 years - 25 percent;

from 15 to 20 years - 30 percent;

from 20 to 25 years - 35 percent;

from 25 years and more - 40 percent.

The assignment of a percentage increase is made on the basis of an order from the manager upon the recommendation of the commission for establishing work experience.

3.2. Employees of healthcare institutions are paid bonuses for the duration of continuous work in these institutions in the manner and amounts established in accordance with the legislative and regulatory acts of the Russian Federation and the Ministry of Internal Affairs of Russia.

4. Bonus payments based on work results.

4.1. Payment of the bonus is carried out based on the results of work for a certain period (month, quarter, other period of the current year).

The procedure and conditions for bonuses (frequency of payment of bonuses, bonus indicators, conditions under which employees may be reduced in bonuses or employees may be deprived of bonuses completely) are established by the regulations on bonuses approved by managers, in agreement with trade union bodies, based on the specific tasks facing in front of institutions.

The specific amounts of bonuses are determined in accordance with the personal contribution of each employee to the implementation of the tasks facing the institution, within the limits of the funds provided for these purposes by the wage fund, and are not limited to maximum amounts.

4.2. Civilian personnel are paid a bonus for conscientious performance of official (labor) duties based on the results of the calendar year (hereinafter referred to as the annual bonus) in the amount of 2 salaries.

4.2.1. The annual bonus is paid in order to ensure the material interest of civilian personnel in the timely and high-quality performance of their official (labor) duties, increasing responsibility for the assigned area of ​​​​work.

4.2.2. All employees employed according to the approved staffing schedules (states) of institutions, including those hired on a part-time basis, have the right to receive an annual bonus.

4.2.3. The annual bonus is paid to the employee in the amount of two monthly salaries actually established for his position (profession) on December 1 of the calendar year for which the annual bonus is paid, and for those dismissed from work during the year - on the day of dismissal.

For employees who have worked for less than a full calendar year, the annual bonus is paid in proportion to the time worked in the year of dismissal (hiring). In this case, the amount of the annual bonus is calculated by dividing the full amount of the annual bonus for the year by the number of calendar days in this year and multiplying by the number of calendar days of the work period in the same year.

Employees hired on a part-time basis, as well as those working part-time work time, the amount of the annual bonus is set based on salaries (official salaries, tariff rates), calculated in proportion to the working time worked for which the annual bonus is paid.

4.2.4. The annual bonus is paid during the first quarter of the year following the expired calendar year, and to those dismissed from work during the year - simultaneously with the final payment.

By decisions of the Commander-in-Chief of the Internal Troops of the Ministry of Internal Affairs of Russia, heads of structural units of the central apparatus of the Ministry of Internal Affairs of Russia and units directly subordinate to the Ministry of Internal Affairs of Russia, heads of the main departments of the Ministry of Internal Affairs of Russia in federal districts, ministers of internal affairs, heads of main departments, departments of internal affairs in the constituent entities of the Russian Federation, departments ( departments) of internal affairs in railway, water and air transport, logistics departments, research and educational institutions of the Ministry of Internal Affairs of Russia, agreed with the FED of the Ministry of Internal Affairs of Russia, payment of the annual bonus can be made in December of the calendar year for which it is paid.

4.2.5. The annual bonus is paid to employees based on the order of the manager.

4.2.6. Managers have the right to deprive employees of an annual bonus for improper performance of official (labor) duties in cases provided for by collective agreements and local regulations.

Deprivation of an annual bonus is formalized by order of the manager with a mandatory indication of the reason.

4.2.7. The annual bonus is not paid to employees:

Those who have concluded an employment contract for a period of up to two months;

Performing work on an hourly basis;

Those on parental leave;

Dismissed from work on the grounds provided for in paragraphs 5 - 11 of Article 81 Labor Code Russian Federation;

Accepted on a probationary period and dismissed if the test result was unsatisfactory.

5. Civilian personnel are provided with other incentive payments established by legislative and regulatory legal acts of the Russian Federation.

6. Incentive payments to managers are established by a senior manager who has the right to appoint to the position.

5 Collection of Legislation of the Russian Federation, 1999, No. 52, Art. 6396; 2000, N 38, art. 3805; 2001, N 48, art. 4526.

Appendix No. 5

The procedure for the formation and use of the wage fund for civilian personnel of military units, institutions and divisions of the Russian Ministry of Internal Affairs system

1. The wage fund for civilian personnel of military units, institutions and divisions of the Russian Ministry of Internal Affairs system is formed based on the number of civilian personnel of the institution.

When calculating the wage fund for civilian personnel, civilian personnel held in regular military positions are also taken into account.

2. The annual wage fund for civilian personnel of the institution is formed based on the amount of funds allocated for payments:

2.1. Salaries (official salaries, tariff rates), including official salaries of heads of institutions 1 - in the amount of 12 salaries.

2.2. Monthly bonus for complexity, tension, high achievements in work and special work mode - in the amount of up to 10 salaries.

The amount of funds allocated for this payment is determined by the main manager of budget funds differentially depending on the type of economic activity and the composition of civilian personnel.

In some cases, by decision of the Minister of Internal Affairs of the Russian Federation, the specified amount of funds may be established in excess of 10 salaries.

2.3. Monthly bonuses for continuous service (length of service), based on the actual amount of this payment in the institution.

2.4. Performance-based bonuses in the amount of 5 salaries.

2.5. Other incentive payments provided for civilian personnel - in the amount of 4 salaries.

3. The wage fund for civilian personnel is formed taking into account:

the size of the regional coefficient, the coefficient for work in desert, waterless areas, the coefficient for work in high mountainous areas, the percentage increase in wages for work in the regions of the Far North and equivalent areas, in the southern regions of Eastern Siberia and the Far East, determined by the relevant regulatory legal acts of the Russian Federation;

other compensation payments established for employees in accordance with the legislative and regulatory legal acts of the Russian Federation and departmental regulations of the Ministry of Internal Affairs of Russia.

4. Heads of institutions, if necessary, have the right to redistribute funds from the corresponding wage funds for civilian personnel between the payments provided for in paragraphs 2 and 3 of this Procedure, in agreement with the superior manager of budget funds, taking into account the unconditional provision of compensation payments established in accordance with the legislation of the Russian Federation.

5. The wage fund for civilian personnel is subject to recalculation in the following cases:

Increases (indexation) of salaries;

Changes in staff (staffing schedules, lists);

Significant changes in wage conditions.

Appendix No. 6

List of regulatory legal acts of the Ministry of Internal Affairs of Russia and individual regulatory requirements

legal acts of the Ministry of Internal Affairs of Russia that have lost force

1 Registered with the Ministry of Justice of Russia on April 10, 2003, registration N 4403, taking into account changes made by order of the Ministry of Internal Affairs of Russia of November 21, 2007 N 1110 (registered with the Ministry of Justice of Russia on December 6, 2007, registration N 10632).

5 Registered with the Ministry of Justice of Russia on November 22, 2007, registration N 10522, taking into account changes made by order of the Ministry of Internal Affairs of Russia dated April 1, 2008 N 299 (registered with the Ministry of Justice of Russia on April 17, 2008, registration N 11547).

7 Registered with the Ministry of Justice of Russia on August 7, 2003, registration N 4962, taking into account changes made by orders of the Ministry of Internal Affairs of Russia dated December 16, 2003 N 984 (registered with the Ministry of Justice of Russia on January 9, 2004, registration N 5391), dated November 29, 2004 N 776 (registered with the Ministry of Justice of Russia on December 17, 2004, registration N 6199), dated May 6, 2005 N 362 (registered with the Ministry of Justice of Russia on June 6, 2005, registration N 6687), dated February 22, 2007. N 184 (registered with the Ministry of Justice of Russia on March 1, 2007, registration N 9001).

8 Registered with the Ministry of Justice of Russia on February 7, 2006, registration N 7455, taking into account changes made by orders of the Ministry of Internal Affairs of Russia dated December 26, 2006 N 1087 (registered with the Ministry of Justice of Russia on February 8, 2007, registration N 8921), dated July 2, 2008 No. 574 (registered with the Ministry of Justice of Russia on July 17, 2008, registration No. 11998).