Medicines are subject to mandatory certification. List of products in respect of which legislative acts Russian Federation mandatory certification is provided for, established by Resolution of the State Standard of the Russian Federation dated July 30, 2002 No. 64 “Nomenclature of products in respect of which the legislative acts of the Russian Federation provide for mandatory certification.” This List includes medicines, chemical-pharmaceutical products and products medical purposes.
Resolution of the State Standard of the Russian Federation dated May 24, 2002 No. 36 approved the Rules for certification in the certification system medicines GOST R certification system (hereinafter referred to as Rules No. 36).
According to Rules No. 36:
“The following medicinal products are subject to mandatory certification:
- produced by drug manufacturing enterprises on the territory of the Russian Federation;
- imported into the territory of the Russian Federation in the manner established by current legislation.”
Groups of medicinal products that are not subject to mandatory certification are given in the Letter of the State Committee of the Russian Federation for Standardization and Metrology dated January 15, 2003 No. IK-110-25/110 “On medicinal products not subject to certification”:
“For information purposes, I inform you that in accordance with the scope of the “Rules for Certification in the Certification System of Medicines of the GOST R Certification System”, approved by the Resolution of the State Standard of Russia dated May 24, 2002 No. 36, and the Law of the Russian Federation “On the Protection of Consumer Rights” is not The following groups of medicines are subject to mandatory certification:
- medicines without individual packaging (in bulk), not intended for retail sale;
- pharmaceutical substances for the production of medicines;
- immunobiological preparations, vaccines, serums (not included in the list of goods for which confirmation of mandatory certification is required).”
The certificate of conformity of a medicinal product is issued by drug certification bodies after checking the medicinal product for compliance with the requirements of regulatory documents approved by the federal body executive power in the field of health care, for the applicant.
Medicine quality certificate- a document confirming the compliance of the quality of the medicinal product with the state standard for the quality of medicinal products (Article 4 of Law No. 86-FZ);
The validity period of the certificate for a batch (series) of medicines is not established. The certificate is valid upon delivery or sale of a batch of products during the shelf life of the medicinal product established regulatory documents.
A production organization that has received a certificate of conformity for manufactured products initially reflects the costs associated with its receipt on account 97 “Deferred expenses”. In accordance with Article 170 of the Tax Code of the Russian Federation, VAT amounts charged to the taxpayer when purchasing goods (work, services) are not included in the expenses accepted for deduction when calculating the income tax (profit tax) of the organization.
This means that the debit of account 97 “Deferred expenses” must take into account the amount of certification costs minus VAT (if there is a corresponding invoice). VAT on the purchased service is recorded as a debit to account 19 “Value added tax on purchased assets.”
Future expenses are written off for production and distribution costs in equal parts during the validity period of the certificate. Consequently, VAT amounts should be deducted in the same way. This point of view is expressed by the tax authorities. This can be confirmed by the Letter of the Department of Taxation of the Russian Federation for the city of Moscow dated August 10, 2004 No. 24-11/52247 “On the legality of VAT deduction.”
The text of Chapter 21 “Value Added Tax” of the Tax Code of the Russian Federation does not contain a direct indication that VAT on expenses of future periods should be deducted only at the time of writing off such expenses on products, that is, in stages. Tax legislation on VAT from January 1, 2006 imposes three requirements that a VAT taxpayer applying for a deduction must fulfill:
purchased goods (works, services), property rights must be used by the taxpayer to carry out taxable transactions;
goods (work, services), property rights must be accepted by the taxpayer for accounting;
The taxpayer must have a properly executed invoice in his hands.
In case of receiving production organization certificate of conformity for manufactured products that we have:
the certificate is required by the organization to carry out taxable activities;
the certification body provided the certification service (based on the signing of the service performance certificate);
the organization accepted the service for accounting, - the accountant reflected the cost of the service on the balance sheet as part of deferred expenses;
The organization has an invoice in its hands.
That is, an organization that is a VAT payer has met all the requirements of tax legislation, so it is possible to deduct all “input” VAT at once.
Using the second point of view may lead to litigation, but we have provided arguments that will help the taxpayer defend his case. If you are not ready to enter into a dispute with the tax authority, use the first point of view.
Note!
Until January 1, 2006 for VAT deduction a necessary condition There was also payment for goods (work, services). From this date, the requirement to pay for purchased goods (work, services), presented to the taxpayer claiming a deduction, was actually removed by the legislator. Such changes have been made to Article 171 of the Tax Code of the Russian Federation Federal law dated July 22, 2005 No. 119-FZ “On amendments to Chapter 21 of Part Two of the Tax Code of the Russian Federation and on the recognition as invalid of certain provisions of acts of legislation of the Russian Federation on taxes and fees” (hereinafter referred to as Law No. 119-FZ). Thus, from January 1, 2006, a VAT taxpayer claiming a deduction must meet only three conditions: the amount of tax must be presented to him for payment, he has an invoice in hand, filled out properly, and the purchased goods (work, services) , property rights must be taken into account.
You can find out more about the issues of certification of medicines in the book of JSC “BKR-Intercom-Audit” “Production and trade in medicine and cosmetics”.
Registration and certification of products ( medications, medical products, dietary supplements, cosmetical tools) in the relevant competent authorities of the Russian Federation and CIS countries.
The first step in the process of introducing a product to the Russian Federation market is its registration. Registration is a state examination of the quality, effectiveness and safety of a drug with the aim of subsequently authorizing the medical use of the drug in the Russian Federation.
Registration procedures for medicinal products, medical products, biologically active additives and cosmetic products in Russia have a number of significant differences.
Registration of medicinal products.
The authorized federal executive body regulating the registration of medicines is the Ministry of Health and Social Development of Russia (www.minzdravsoc.ru).
A separate Department has been formed in the Ministry of Health and Social Development of Russia government regulation Circulation of Medicines, whose department deals with issues of registration of new and circulation of already registered medicines.
In 2010, the procedure for registering medicines was significantly changed due to the adoption of the new Federal Law No. 61-FZ “On the Circulation of Medicines” dated April 12, 2010, which came into force on September 1, 2010. To date, 4 changes to the law have been adopted: No. 192-FZ of July 27, 2010, No. 271-FZ of October 11, 2010, No. 313-FZ of November 29, 2010, No. 409-FZ of December 6, 2011.
Regulatory legal acts regulating the registration procedure for medicines:
- Federal Law No. 61-FZ “On the Circulation of Medicines” dated April 12, 2010 (came into force on September 1, 2010).
- Order of the Ministry of Health and Social Development of the Russian Federation dated November 23, 2011 N 1413n “On approval of Methodological recommendations on content and design necessary documents, from which the registration dossier for a medicinal product for medical use is formed for the purpose of its state registration».
- Order No. 750n dated August 26, 2010 “On approval of the rules for conducting the examination of medicines for medical use and the form of the expert commission’s conclusion.”
Registration procedure for foreign and Russian drugs the same.
The registration procedure consists of 4 consecutive stages:
- Drawing up a registration dossier, including documents necessary to get started clinical trial, and submission of the dossier to the Ministry of Health and Social Development of Russia.
- Obtaining permission to conduct a clinical trial and conduct it in the Russian Federation.
- Examination of the quality of a medicinal product and examination of the relationship between expected benefit and possible risk use of a medicinal product carried out after its clinical trial: The third stage can be divided into 2 substages:
3a). Quality control of the drug in the laboratory of the Federal State Budgetary Institution NTsESMP and approval of the Regulatory Document;
3b). Examination of the relationship between the expected benefit and the possible risk of use and approval of the Instructions for the medical use of the drug.
- Making a decision by the Ministry of Health and Social Development of Russia to include the drug in the State Register of Medicines and issuing a registration certificate.
Registration deadlines
In accordance with Law No. 61-FZ “On the Circulation of Medicines”, the registration period is 210 working days. This period does not include the time required to conduct a clinical trial.
Registration of medical devices
The authorized federal executive body regulating the registration of medical products is Roszdravnadzor (www.roszdravnadzor.ru).
The procedure for registration of medical devices is regulated by the “Administrative Regulations of the Federal Service for Surveillance in Healthcare and social development to provide public services for registration of medical products, as well as providing citizens and organizations with access to information about medical products that have been registered"
Normative base:
- Draft Federal Law “On Medical Devices”.
- Order of the Ministry of Health and Social Development of the Russian Federation dated October 30, 2006 N 735 “On approval of the Administrative Regulations of the Federal Service for Surveillance in the Sphere of Health and Social Development for the performance of the state function of registering medical products.”
- Decree of the Government of the Russian Federation of September 15, 2008 N 688 “On approval of lists of codes of medical goods subject to value added tax at a tax rate of 10 percent.”
- Order of the Federal Service for Surveillance in the Sphere of Healthcare and Social Development dated November 9, 2007 N 3731-Pr/07 “On approval of the nomenclature classifier of medical devices and medical equipment (medical products).”
- Decree of the Government of the Russian Federation of August 13, 1997 N 1013 “On approval of the list of goods subject to mandatory certification and the list of works and services subject to mandatory certification.”
- Letter of the Federal Customs Service of Russia dated March 27, 2008 N 01-11/11534 “On sending the List of goods for which sanitary and epidemiological certificates or certificates of state registration must be issued during customs clearance.”
- State registration of medical devices is carried out by Roszdravnadzor on the basis positive results relevant tests (research) (technical, toxicological, clinical), as well as positive conclusions of Expert Commissions on examination of the quality, effectiveness and safety of medical products.
The period for providing the state service for state registration of a medical device should not exceed 140 days from the date of registration with Roszdravnadzor of the set of documents provided for in paragraphs. 26-29 of the Administrative Regulations.
Detailed information on state registration of imported medical devices on the Roszdravnadzor website:
State registration of food additives and cosmetics
The authorized federal executive body regulating the registration of dietary supplements and cosmetics is Rospotrebnadzor (www.rospotrebnadzor.ru)
Registration of dietary supplements, cosmetics, food additives, raw materials for dietary supplements is carried out in accordance with:
- Order of the Ministry of Health and Social Development of the Russian Federation dated October 19, 2007 N 657 “On approval of the Administrative Regulations of the Federal Service for Surveillance in the Field of Protection of Consumer Rights and Human Welfare for the performance of the state function of state registration of chemicals introduced into production for the first time and previously not used, biological substances and drugs manufactured on their basis that are potentially dangerous to humans (except for medicines); individual species products that pose a potential danger to humans (except for medicines); certain types of products, including food products, imported into the territory of the Russian Federation for the first time,” as well as
- Federal Law of January 2, 2000 N 29-FZ “On the quality and safety of food products”.
- Order of the Federal Service for Surveillance in the Sphere of Consumer Rights Protection and Human Welfare of July 19, 2007 N 224 “On sanitary and epidemiological examinations, examinations, research, testing and toxicological, hygienic and other types of assessments.”
- Letter of the Federal Customs Service of Russia dated March 27, 2008 N 01-11/11534 “On sending the List of goods for which sanitary and epidemiological certificates or certificates of state registration during customs clearance must be issued”
- Decree of the Government of the Russian Federation of September 15, 2008 N 688 “On approval of lists of codes of medical goods subject to value added tax at a tax rate of 10 percent.”
- Order of the Federal Service for Surveillance in the Sphere of Consumer Rights Protection and Human Welfare of July 19, 2007 N 224 “On sanitary and epidemiological examinations, examinations, research, testing and toxicological, hygienic and other types of assessments.”
Documents provided by the applicant for state registrationhttp://rospotrebnadzor.ru/directions_of_activity/gosreg/33350
After receiving the Certificate of State Registration, it is necessary to undergo procedures to confirm the quality of the product in the form of certification or declaration.
Certification and declaration
Each product sold in Russia must meet the requirements of certain state standards. That is why a certificate or declaration must be issued for goods that, one way or another, can affect the life and health of people.
Certificate of conformity is official document, which confirms the conformity of the certified product necessary requirements quality and safety established for this product by current standards: GOSTs or technical regulations.
Declaration – required form certification, through which the applicant, on the basis of available own evidence or evidence obtained with the direct participation of the certification body, certifies that the products released into free circulation by him comply with the requirements of the provisions of state standards.
The procedure for accepting a declaration of conformity is carried out directly by the manufacturer or supplier of certain goods on the basis of available documentary evidence confirmed as a result of an independent examination.
Products, passed the procedure declaration, has official proof high level quality, and ultimately inspires consumer confidence.
All company services are provided in strict accordance with legal requirements, as well as the company's codes of ethical business conduct and marketing practices.
In order to prevent counterfeiting of medicines, the state certification system has a provision on a mandatory certificate for medicines. Control of manufactured pharmaceutical products is very important in conditions Russian market. Steady rise in prices for medicines provokes artisanal production of medicines and counterfeiting medical supplies. To others negative indicator What makes drug certification necessary is the unacceptable rate of defects in pharmaceutical production. The pharmacy must provide the buyer with a sanitary and epidemiological certificate for any drug. Medicines are included in the nomenclature list of products subject to mandatory certification. Four types of drug certificates have been developed:
Certificate of production activity, which confirms that the quality control of pharmaceutical production is at the required level
Certificate for a pharmaceutical product intended for export
Medicines produced and imported into the territory of the Russian Federation must be certified in mandatory. Roszdravnadzor strictly monitors this. The Medicines Certification Center issues a certificate for pharmaceutical products only if the test results of an independent accredited laboratory meet the required standards and norms. The medicines certification system provides for certification actions based on an application submitted to the certification body. The procedure for certification of medicines involves submitting an application to the certification center, reviewing the application and documents, developing a certification scheme, and conducting laboratory tests of provided samples. Next, there is an analysis of technical documentation and research results, a decision to issue or refuse a certificate, registration of a certificate, inspection control of the quality of certified products put into circulation, corrective actions aimed at improving product quality to the required state standards and norms. To quickly and efficiently obtain a mandatory quality certificate for medicines, contact our certification center, whose specialists have been involved in certification in the pharmaceutical field for a long time. By calling the specified phone number, you can receive comprehensive information regarding the certification of medicines and other medical products. We will be happy to provide you with any help and support to obtain a certificate with a 100% guarantee of a positive result.
In order to prevent counterfeiting of medicines, the state certification system has a provision on a mandatory certificate for medicines. Control of manufactured pharmaceutical products is very important in the Russian market. The steady increase in prices for medicines provokes artisanal production of medicines and counterfeiting of medicines. Another negative indicator that makes drug certification necessary is the unacceptable rate of defects in pharmaceutical production. The pharmacy must provide the buyer with a sanitary and epidemiological certificate for any drug. Medicines are included in the nomenclature list of products subject to mandatory certification. Certification of medical devices, as mentioned above, is a prerequisite for their release into circulation in the Russian Federation. Four types of drug certificates have been developed:
Certification of conformity serves as confirmation that medicinal products meet GOST requirements regarding product quality
Certificate of production activity, which confirms that the quality control of pharmaceutical production is at the proper level
The registration certificate indicates that a certain medicinal product is permitted on the territory of the Russian Federation
Certificate for a pharmaceutical product intended for export.
Medicines produced and imported into the Russian Federation must be certified. Roszdravnadzor strictly monitors this. The Medicines Certification Center issues a certificate for pharmaceutical products only if the test results of an independent accredited laboratory meet the required standards and norms. The medicines certification system provides for certification actions based on an application submitted to the certification body. The procedure for certification of medicines and drugs involves submitting an application to the certification center, reviewing the application and documents, developing a certification scheme, and conducting laboratory tests of provided samples. Next, there is an analysis of technical documentation and research results, a decision to issue or refuse a certificate, registration of a certificate, inspection control of the quality of certified products put into circulation, corrective actions aimed at improving product quality to the required state standards and norms.
Certification of medical devices is carried out by local authorities of Roszdravnadzor. However, it must be emphasized that certification must be carried out not only pharmaceuticals, but also equipment. Certification medical equipment implies several types of design in different government agencies. These steps must be completed to use the equipment in medical institution. This is not only a sanitary and epidemiological conclusion, but also registration in the register of the Ministry of Health. Certification of medical equipment is not the only condition for its use in hospitals and clinics. There is an institute for licensing medical technology and equipment. There is a special instruction that regulates the procedure for hygienic assessment of medical devices. It is very important to provide all technical documentation, including technical specifications, for registration of medical equipment.
Certification of medical products is the most important condition for successful implementation in Russia. However, certification of equipment and medical products is associated with various difficulties of state registration. The collection of documentation and a certain procedure for certification actions are required, so it would be best to entrust this procedure to the experienced specialists of our certification center. To quickly and efficiently obtain a mandatory quality certificate for medicines, contact our certification center, whose specialists have been involved in certification in the pharmaceutical field for a long time. By calling the specified phone number, you can receive comprehensive information regarding the certification of medicines and other medical products. We will be happy to provide you with any help and support to obtain a certificate with a 100% guarantee of a positive result.
System for confirming the compliance of medicines and medical devices with regulatory quality requirements Lecture for 4th year students of the Tyumen State Medical University of the Ministry of Health of the Russian Federation Department of Management and Economics of Pharmacy Medical and Pharmaceutical Commodity Science
2 Lecture plan 1. Regulatory framework systems for confirming compliance in healthcare and pharmacy in the Russian Federation. 2. System of conformity assessment in the Russian Federation. Legislative basis. Basic concepts. 3. Types and forms of confirmation of compliance (voluntary, mandatory). 4. Russian Federation certification system. Certification authorities. Structure of certification bodies. Main goals and objectives, powers. 5. Declaration of conformity of drugs. Basic provisions. Documents confirming the compliance of the drug.
3 3 Regulatory framework for the system of conformity assessment (certification) in healthcare and pharmacy: Federal Law of December 27, 2002 No. 184 -FZ “On Technical Regulation”; Law of the Russian Federation “On the Protection of Consumer Rights” (dated 02/07/1992, as amended); Federal Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (as amended); Federal Law of April 12, 2010 No. 61-FZ “On the Circulation of Medicines”; Decree of the Government of the Russian Federation dated 01.12.2009 No. 982 “On the Unified List of Products, confirmation of conformity of which is carried out in the form of mandatory certification and the Unified List of Products, confirmation of conformity of which is carried out in the form of accepting a declaration of conformity”; Order of the Ministry of Industry and Energy of the Russian Federation dated December 26, 2006 No. 425 “On approval methodological recommendations on the adoption and registration of the declaration of conformity of medicines” and other regulatory legal acts.
4 4 Legislative framework The basic concepts, goals, principles, types and forms of activity in the field of conformity assessment, as well as the functions of certification bodies are established by the Federal Law of December 27, 2002 No. 184 -FZ “On Technical Regulation”
5 Confirmation of conformity - documentary certification of the compliance of products or other objects, design processes (including surveys), production, construction, installation, commissioning, operation, storage, transportation, sale and disposal, performance of work or provision of services with the requirements of technical regulations, provisions of standards, codes rules or terms of contracts.
6 6 Confirmation of conformity is carried out for the purposes of: certifying the compliance of products, production processes, operation, storage, transportation, sales and disposal, works, services or other objects with technical regulations, standards, terms of contracts; assistance to purchasers in the competent selection of products, works, services; increasing the competitiveness of products, works, services in the Russian and international markets; creating conditions to ensure the free movement of goods across the territory of the Russian Federation, as well as for the implementation of international economic, scientific and technical cooperation and international trade.
7 The conformity confirmation form is a specific procedure for documenting the compliance of products or other objects, design processes (including surveys), production, construction, installation, adjustment, operation, storage, transportation, sale and disposal, performance of work or provision of services with the requirements of technical regulations , provisions of standards or terms of contracts.
8 8 Types and forms of confirmation of conformity (Article 20 of the Federal Law “On Technical Regulation”) Type 1 - Voluntary confirmation of conformity in the form of Voluntary Certification. Type 2 - Mandatory confirmation of conformity in two forms: Mandatory certification Declaration of conformity
9 Voluntary confirmation of conformity - Voluntary confirmation of conformity is carried out at the initiative of the applicant under the terms of the agreement between the applicant and the certification body. Voluntary confirmation of conformity can be carried out to establish compliance with national standards, organizational standards, voluntary certification systems, and contract terms.
10 10 Mandatory confirmation of conformity is a specified set of actions officially accepted as evidence of compliance of medicinal products with the requirements of technical regulations and standards.
11 11 Declaration of conformity of medicines - Since January 1, 2007, mandatory certification of medicines has been replaced by a declaration of conformity. Declaration simplifies the process of mandatory confirmation of compliance with established requirements for the manufacturer (seller) of drugs, and also increases his responsibility. After January 1, 2010, declaration of conformity is also provided for medical devices
12 12 The following are subject to declaration: Medicines produced by manufacturing enterprises on the territory of the Russian Federation; Medicines imported into the territory of the Russian Federation in the manner prescribed by current legislation.
13 Declaration of conformity is a document certifying the compliance of products released into circulation with the requirements of technical regulations. The completed declaration of conformity is subject to registration by a body authorized by the federal executive body for technical regulation and standardization (Rosstandart). The declaration acquires legal force only after registration.
14 14 The form for the declaration of product conformity with the requirements of technical regulations, as well as recommendations for filling it out, were approved by Order of the Ministry of Industry and Energy of the Russian Federation dated March 22, 2006 No. 54 “On approval of the form for the declaration of product conformity with the requirements of technical regulations.”
The essence of the declaration The declaration of conformity is accepted by the declarant - the manufacturer or seller himself (legal or an individual, registered as an individual entrepreneur, or performing the functions of a foreign manufacturer on the basis of an agreement with him). When accepting the declaration, the declarant - manufacturer (supplier) declares that the product it puts into circulation meets the quality standards adopted in the Russian Federation. At the same time, he presents the necessary evidence (his own or with the participation of a third party).
Own evidence passport (analysis protocol) of the manufacturer (for domestic drugs); company quality certificate (for foreign drugs); documents confirming the origin of the drug; protocols of incoming control (tests) for raw materials, intermediate products, substances and materials used in the production of drugs; documents confirming the origin of the raw materials used in the production of this drug.
Evidence with the participation of a third party 1. With the participation of an accredited testing center (testing laboratory): . test reports carried out according to quality and safety indicators established in regulatory documentation for this drug. 2. With the participation of the certification body: . certificates of conformity issued for production or quality system (QMS), certified in the Certification System.
18 Certification (184 -FZ “On Technical Regulation”) Certification is a form of confirmation of compliance of objects with the requirements of technical regulations, provisions of standards, sets of rules or terms of contracts carried out by a certification body. “Certification” translated from Latin means “done correctly.” To know that a product is made correctly, you need to have information about what requirements the product must meet and how to obtain proof of this compliance.
19 Certification body: – entity or individual entrepreneur, accredited in the prescribed manner to carry out certification work (centers for certification of medicines and medical products). It carries out: confirmation of conformity, issues certificates of conformity (for medical devices), registration of declarations of conformity (for drugs, dietary supplements), grants applicants the right to use a mark of conformity with the national standard, suspends or terminates the validity of certificates of conformity issued to them.
20 Certificate of conformity is a document certifying the compliance of an object with the requirements of technical regulations, provisions of standards, codes of practice or terms of contracts.
21 A certification system is a set of: rules for performing certification work, participants, rules for the functioning of the certification system as a whole. (source: Federal Law “On Technical Regulation”, Article 2)
22 22 What is subject to mandatory certification (RF Law “On the Protection of Consumer Rights”)? Goods (works, services) for which state standards requirements have been established aimed at ensuring life safety, consumer health and protection environment, as well as to prevent damage to consumer property. Means ensuring the safety of life and health of consumers.
23 23 Powers of accredited Medicines Certification and Quality Control Centers Quality control centers have the right to: carry out inspection control over products certified by them once every 6 months (if provided for by the certification scheme); be involved by Roszdravnadzor to conduct an examination of the quality, safety and effectiveness of drugs on the basis of agreements with federal service and its territorial bodies in accordance with the assignment received (general or private); register declarations of conformity of product quality with established requirements if appropriate accreditation is available.
24 Unified all-Russian register of issued certificates of conformity and registered declarations of conformity The Federal executive body for technical regulation and metrology (Rosstandart) maintains a unified all-Russian register of issued certificates of conformity and registered declarations of conformity. The register is formed on the basis of information provided by certification bodies.
25 25 Information for consumers about the quality of medicines Documents REQUIRED for the sale of drugs: Declaration of conformity; A copy of the declaration of conformity, certified by the holder of the declaration; Product accompanying documents (including, for example, a register of certificates or declarations), certified by the signature and seal of the manufacturer (supplier, seller).
26 26 Necessary information on confirming the conformity of goods in the shipping documents: For medicines, MI, dietary supplements, PFT: Registration number of the declaration of conformity; Validity period of the declaration; Name of the manufacturer or supplier (seller) who accepted the declaration; The body that registered the declaration. For other product groups: Certificate of conformity number; Its validity period; The authority that issued the certificate.
Mark of market circulation 27 designation used to inform purchasers about the compliance of products put into circulation with the requirements of technical regulations. The image of the sign of circulation on the market is established by Decree of the Government of the Russian Federation dated November 19, 2003 No. 696. This sign is not a special protected sign and is applied for information purposes (Article 27 of the Federal Law “On Technical Regulation” dated December 27, 2002 No. 184-FZ) . The market circulation sign is a combination of the letters “T” (with a dot above it) and “P” inscribed in the letter “C”, stylized as a measuring bracket, having the same height and width (4 options).
28 28 Mark of conformity is a designation used to inform purchasers about the compliance of the certification object with the requirements of the voluntary certification system or national standard
A sanitary-epidemiological conclusion, also known as a “hygienic certificate”, is a document confirming that products comply with established hygienic standards (GN) and sanitary rules(San.P.N). A sanitary and hygienic certificate is issued by Rospotrebnadzor after an examination of products (production conditions, specifications) based on a test report and submitted documents. The validity of the hygiene certificate is 5 years.
Pharmacy products and documents confirming their quality Medicines Declaration of Conformity Immunobiological preparations Certificate of conformity MIBP (IBLP) Dietary additives Declaration of conformity (since 01.2012) Registration certificate of dietary supplements + test protocol for radionuclides Perfume, cosmetics and oral care products Declaration of conformity (GOST R Certificate of Conformity with reference to sanitary -epidemiological conclusion) Spectacle lenses, frames, heating pads, ice packs, oilcloth lining Declaration of conformity Dressings; MI; honey. technique; goods in contact with the human body Declaration of conformity (Certificate of Conformity GOST R) Nutritional supplements, min. water, products for children, hygiene products, etc. Sanitary and epidemiological report (documents on the quality of the manufacturer) → 2 holographic signs on the copy
32 32 ACCREDITATION is the official recognition of the right of a quality control center or testing laboratory to carry out specific tests or types of tests (recognition of technical competence, objectivity).
33 33 The list of testing laboratories (centers) accredited for testing medicinal products for the purpose of declaring their conformity includes more than 74 organizations various forms property
The main tools for ensuring the quality of medicinal products in the distribution chain are drug certification and assessment of their conformity.
Certification- this is an activity to confirm the compliance of products with the norms, rules, and characteristics established during the standardization process.
In accordance with the Law of the Russian Federation “On the Protection of Consumer Rights”; Law of the Russian Federation “On certification of products and services”; Decree of the Government of Russia dated August 13, 1997 No. 1013 “On approval of the List of works and services subject to mandatory certification”; Decree of the Government of Russia dated April 29, 2002 No. 287 “On amendments to the List of goods subject to mandatory certification and to the List of products whose compliance can be confirmed by a declaration of conformity”; The “Certification System for Medicines of the GOST R Certification System” was developed and approved. The basic rules and requirements related to the procedure for certification of domestic and foreign-made drugs registered in Russia are determined by the “Rules for certification in the Certification System for Medicines of the GOST R Certification System”, approved by Resolution of the State Standard of Russia dated May 24, 2002 No. 36 and put into effect with 12/15/2002.
Certification (in translation from Latin - “done correctly”) can be mandatory or voluntary. The mandatory certification mechanism also provides for confirmation of compliance through acceptance Declaration of Conformity.
Declaration of Conformity is a document in which the manufacturer (seller, performer) certifies that the products supplied (sold) by him meet the established requirements.
The declaration of conformity, adopted in the prescribed manner, is registered with the certification body and has legal force on par with the certificate.
Since October 1, 2004, in accordance with the Decree of the Government of Russia dated February 10, 2004 No. 72, drugs have been excluded from the list of goods subject to mandatory certification. By Decree of the Government of Russia dated April 29, 2006 No. 255 “On amendments to Decree of the Government of the Russian Federation dated February 10, 2004 No. 72,” from January 1, 2007, certification of drugs is replaced by a declaration of conformity.
The circulation of drugs on the Russian pharmaceutical market is carried out only after registration of a declaration of conformity of the drug with the requirements of regulatory documents (general pharmacopoeial monographs, pharmacopoeial monographs, pharmacopoeial monographs of enterprises, regulatory documents for drugs of foreign production).
A declaration of conformity of a drug can be accepted for a specific series of drugs. The declaration is accepted by the declarant on the basis of his own evidence and evidence obtained with the participation of a third party, which is accepted as: test reports conducted in an accredited testing laboratory (center), or certificates of conformity for production or quality system of the GOST R Certification System.
Process declaration different from the process certification the fact that the certification body itself selected both drug samples for examination and the testing laboratory, applied and received an examination conclusion and, as a result, issued a certificate of conformity. In case of confirmation of conformity in the form of a declaration, the applicant selects both a testing laboratory and a certification body that registers declarations of conformity. He can either independently select samples for examination or entrust the selection of samples on a contractual basis to a testing laboratory or certification body. Required condition when sampling - compliance with the requirements of regulatory documents, drawing up a sampling report and submitting it to the testing laboratory.
The Declaration of Conformity contains the following information:
· name and location of the applicant for the declaration of conformity or the holder of the registration certificate for the medicine;
· name and location of the manufacturer (manufacturers);
· name of the drug, its dosage form and dosage;
· active substances and their quantity per dose unit;
· drug state registration number;
· number of the produced series;
· date of manufacture;
· number of consumer packages in a series;
· an indication that the declaration of conformity is carried out on the basis of one’s own evidence, indicating the date and number of the analysis protocol;
· shelf life of the drug series;
· signature of an authorized person.
The registered declaration of conformity of the drug, together with the documents on the basis of which it was accepted, is kept by the declarant for at least three years after the expiration of its validity period.
Certificate of conformity of quality systems (production) - a document certifying that the quality system (production) of the drug declared by the manufacturer meets the established requirements.
Certificate of conformity of the medicinal product- a document certifying the compliance of the drug with all the requirements of regulatory documents, issued in the drug certification system.
A uniform certificate of conformity for a drug is issued by drug certification authorities after checking the drug for compliance with the requirements of regulatory documents approved by the Ministry of Health of Russia for the applicant.
The certificate is valid upon delivery or sale of a batch of products during the shelf life of the drug established by regulatory documents. Medicines in circulation as of April 1, 2007 and having a certificate of conformity issued in the prescribed manner are not subject to declaration (Resolution of the Government of Russia dated November 28, 2006 No. 810).
Inspection control of certified products (if provided for by the certification scheme) is carried out during the entire validity period of the certificate, at least once every 6 months in the form of periodic and unscheduled inspections, including drug testing and other checks necessary to confirm that the products being manufactured and sold continues to meet the established requirements confirmed during certification.
In the wholesale trade of drugs, information on confirmation of the conformity of drugs sold is presented in the form of transfer from the seller to the buyer of a copy of the certificate of conformity certified in the manner established by the Government of the Russian Federation or the original declaration of conformity. On the reverse side of the copy of the certificate of conformity, a record is made of the sale of the goods, indicating information about the buyer and the quantity of goods sold. The original certificate of conformity (a copy certified in the prescribed manner) is kept by the holder of the original (certified copy) until the expiration of the certificate of conformity.
In retail trade, the seller has the right to bring to the attention of the consumer information about confirmation of drug compliance with established requirements using one of the following documents:
· certificate of conformity or declaration of conformity;
· a copy of the certificate of conformity, certified by the holder of the original certificate, a notary or the certification body that issued the certificate;
· commodity accompanying documents prepared by the manufacturer or supplier (seller), containing for each product name information on confirmation of its compliance with the established requirements (number of the certificate of conformity, its validity period, the body that issued the certificate, or registration number declaration of conformity, its validity period, the name of the manufacturer or supplier who accepted the declaration, and the body that registered it), and certified by the signature and seal of the manufacturer (supplier, seller) indicating his address and telephone number.
In addition, in accordance with clauses 71 and 72 of the “Rules for the sale of certain types of goods”, approved by Decree of the Government of the Russian Federation No. 55 in 1998, information about drugs and medical devices must contain information about the state registration of the drug, indicating the number and date of its registration registration (except for extemporaneous drugs). Information about medical devices should contain, taking into account the characteristics of a particular type of product, information about its purpose, method and conditions of use, action and effect, restrictions (contraindications) for use. This information is usually contained in certificates of conformity, which are issued after state registration and contain information about its number and date in the “Bases” section. In accordance with OST 91500.05.0007-03, all deliveries of goods must be accompanied by documents allowing to establish: date of shipment, name of the drug (including dosage form and dosage), series and batch number, quantity of goods supplied, price of the drug supplied, name and address of the supplier and buyer, as well as documents confirming quality.
Documents confirming the quality of medical equipment are:
· sanitary and epidemiological conclusion;
· and certificate of conformity.
For glasses (except for sunglasses) - a declaration of conformity.
For biologically active food additives (BAA) - a certificate of quality and safety (for each batch) and a sanitary-epidemiological conclusion (copy) for a period of 5 years, and for a pilot batch for 1 year (previously a registration certificate was issued for 3 years or 5 years). A new dietary supplement requires a certificate of state registration of new food products, materials and products, perfumery and cosmetic products.
