Regulatory and legal regulation of quality control medicines
State control over the quality of medicines includes measures aimed at compliance with the requirements of acts of legislation of the Russian Federation regulating the provision of medicines, and all medicines imported and manufactured in the Russian Federation and imported into the territory of the Russian Federation are subject to it.
Medicines are special products that can cause harm to human health if the rules of development, testing, production, storage, sale, and use are violated. Therefore, it is necessary to introduce a strictly regulated system for monitoring all stages of drug promotion from their creation to human consumption. State control over the quality of drugs in the Russian Federation is regulated by the following main regulatory documents:
Law Russian Federation dated February 7, 1992 N 2300-1 “On the protection of consumer rights” (as amended and supplemented on June 2, 1993, January 9, 1996, December 17, 1999, December 30, 2001, August 22 2004);
Resolution of the State Standard of Russia dated May 24, 2002 No. 36 On the approval and implementation of the “Rules for certification in the Certification System of Medicines of the GOST Certification System of the Russian Federation”;
Decree of the Government of the Russian Federation of July 7, 1999 No. 766 “On approval of the list of products subject to declaration of conformity, the procedure for accepting a declaration of conformity and its registration”;
Decree of the Government of the Russian Federation dated December 1, 2009 No. 982 “On approval of a unified list of products subject to mandatory certification, and a unified list of products, confirmation of conformity of which is carried out in the form of acceptance of a declaration of conformity";
Decree of the Government of the Russian Federation of July 6, 2006 No. 416 “On approval of the Regulations on licensing of pharmaceutical activities”;
Decree of the Government of the Russian Federation of September 3, 2010 No. 684 “On approval of the Regulations on licensing the production of medicines”;
Order of the Ministry of Health of the Russian Federation dated October 30, 2006 No. 734 “On approval of the Administrative Regulations of the Federal Service for Surveillance in Healthcare for the performance of the state function of organizing the examination of the quality, effectiveness and safety of medicines”;
Order of the Ministry of Health of the Russian Federation dated March 4, 2003 N 80 “On approval of the Industry Standard “Rules for the dispensing (sale) of medicines in pharmacies. Basic provisions";
Order of the Ministry of Health of the Russian Federation dated December 28, 2010 No. 1222n “On approval of the Rules for the wholesale trade of medicines for medical use";
Order of the Ministry of Health of the Russian Federation of August 23, 2010 N 706n “On approval of rules for storing medicines”;
Order of the Ministry of Health of Russia dated July 16, 1997 No. 214 “On quality control of medicines manufactured in pharmacies”;
Order of the Ministry of Health of Russia dated October 21, 1997 No. 309 “On approval of instructions on the sanitary regime of pharmacy organizations (pharmacies)”;
Order of the Ministry of Health of Russia dated October 21, 1997 No. 308 "On approval of instructions for the production of liquid liquids in pharmacies dosage forms";
Order of the Ministry of Health of Russia dated October 16, 1997 No. 305 “On the norms of deviations permissible in the manufacture of medicines and packaging of industrial products in pharmacies.”
These Rules define the basic principles and requirements related to the certification procedure for domestic and foreign-made medicines registered in the State Register in order to protect the rights and interests of consumers and pursue a unified state policy in the field of providing the population with high-quality medicines.
II. The procedure for mandatory certification of medicines
1. General requirements to the procedure for mandatory certification of medicines are established by the Procedure for carrying out certification of products in the Russian Federation (Resolution of the State Standard of the Russian Federation dated September 21, 1994 N 15) with Amendment No. 1 of the Procedure for carrying out certification of products in the Russian Federation (Resolution of the State Standard of the Russian Federation dated July 25, 1996 N 15 ); Rules for the use of the mark of conformity for mandatory certification of products (Resolution of the State Standard of the Russian Federation No. 14 of July 25, 1996).
2. The certificate of conformity of a medicinal product is issued by the medicinal product certification authorities after checking the medicinal product for compliance with the requirements regulatory documents approved by the federal authority executive power in the field of health care, for the applicant.
The validity period of the certificate for a batch (series) of medicines is not established. The certificate is valid for the supply or sale of a batch of products during the shelf life of the medicinal product established by regulatory documents.
3. Certification bodies for medicines must use test results issued by any testing laboratory accredited in the prescribed manner, if the analysis is performed according to all indicators provided for by regulatory documents.
4. Certification of imported medicines is carried out according to the same rules and schemes as domestic products for compliance with the requirements of regulatory documents approved by the federal executive body in the field of healthcare. Certification of imported medicines can be carried out by a medicines certification body accredited in the Medicines Certification System of the GOST R Certification System.
5. The procedure for certification of medicines includes:
Submitting an application to the certification body;
Review of the application and documents submitted by the applicant;
Making a decision on the application, choosing a certification scheme;
Sampling;
Product identification;
Testing;
Certification of quality systems (production), if provided for by the certification scheme;
Analysis of the results of tests, inspections and making a decision on issuing (refusing to issue) a certificate of conformity;
Registration and issuance of a certificate of conformity;
Carrying out inspection control over certified products (if provided for by the certification scheme);
Corrective measures in case of violation of product compliance with established requirements and misuse mark of conformity;
Information about certification results.
6. To carry out work on certification of medicines, the applicant sends an application to the certification body.
7. The certification body reviews the application and makes a decision on it no later than 3 days. Based on the results of consideration of the application, the certification body draws up and sends to the applicant a decision on the application.
8. Selection, identification of samples and their testing.
8.1. The number of samples, the procedure for their selection and identification rules are established in accordance with regulatory documents on the certification of medicines and test methods approved by the federal executive body in the field of healthcare.
Testing of medicinal products of domestic and foreign production during certification should be carried out only in accordance with regulatory documents approved by the federal executive body in the field of healthcare (general pharmacopoeial monographs, pharmacopoeial monographs, pharmacopoeial monographs of enterprises, regulatory documents for foreign-made medicinal products).
8.2. The selection of samples for testing is carried out by the certification body or a competent organization authorized by the central body.
8.3. Samples are taken at the applicant's warehouse in the quantity necessary to conduct 3 analyzes for all indicators provided for by regulatory documents.
8.4. The selection of samples is documented in an act. Selected samples are isolated from the main products, packaged, sealed or sealed at the sampling site. The release of selected samples (samples) of medicinal products is formalized in accordance with the procedure established by the enterprise.
8.5. The certification body carries out product identification in accordance with the requirements established by the federal executive body in the field of healthcare. Identification is carried out: for belonging to the declared batch; the legality of its production and sale (availability of a license); for compliance with documents confirming the origin of products and containing information about their quality and quantity; for compliance with the specified name and information indicated on the packaging, by assessing the indicators “description”, “packaging”, “labeling”.
When identifying, the certification body considers the following documents:
A copy of the license for the right to produce (sell) medicines, certified by a notary;
Manufacturer's protocol of analysis (for domestic medicines) or the company's certificate of analysis and its translation (for foreign medicines) with the results of checking the quality of medicines for compliance with the requirements of regulatory documents upon release;
A document confirming the origin (purchase) of medicines;
Documented information about the quantity of the certified medicinal product.
In order to reduce the period of certification work, the applicant submits the documents considered for the identification of medicinal products simultaneously with the submission of the application.
If, based on the results of product identification, it is determined that the product does not correspond to the declared name, accompanying documentation, description, packaging or labeling, the applicant is notified that further certification work is not carried out.
8.6. Samples of medicinal products are transferred by the certification body to the testing laboratory with the appropriate direction indicating the types of required certification tests and a copy of the certificate of sampling of medicinal products.
Samples of medicinal products remaining from testing are stored in the certification body for at least 6 months, after which medicinal products that meet the requirements of the regulatory document are transferred free of charge, with the consent of the applicant, to healthcare institutions or returned to the applicant with a transfer certificate, those that do not satisfy are destroyed with execution of an act of destruction. Requirements for labeling and recording of samples are established in the documents of the certification body.
8.7. The test results are documented in the form of a test report, which must reflect the actual data of the experimental test, have a conclusion on compliance with the requirements of the regulatory document and must be signed by the head of the testing laboratory. The test report in two copies is submitted to the certification body or, if the applicant applied directly to the testing laboratory for the purpose of conducting tests on all indicators of regulatory documents, to the applicant. Test reports must be stored for the entire shelf life of the medicinal product.
8.8. If the quality of medicinal products does not comply with the requirements of regulatory documents, the testing laboratory sends a conclusion with a test report to the certification body for medicinal products and the federal executive body in the field of healthcare.
The storage period for test reports of medicinal products, the quality of which does not meet the requirements of regulatory documents, is established for testing laboratories by the federal executive body in the field of healthcare, but cannot be less than 6 months.
Information about the identification of non-compliance of a medicinal product with the requirements of a regulatory document during certification is sent by the medicinal product certification body to the applicant, to the federal executive body in the field of healthcare, with the submission of a test report.
In cases where testing laboratories cannot assess the quality of medicinal products in accordance with the requirements of this document, samples of these medicinal products with accompanying documents are recommended to be sent to the Institute of State Control of Medicines. Samples of medicinal products are sent for testing in the quantity necessary to carry out 3 analyzes for all indicators provided for by regulatory documents, including testing for microbiological purity, with a covering letter, a sample collection report, an original or a certified copy of the analysis protocol carried out by the manufacturer.
8.9. The certification body, after identifying products, analyzing test reports, certifying the quality (production) system (if established by the certification scheme) and analyzing the submitted documents, assesses the compliance of medicinal products with regulatory documents. The test results must fully and reliably confirm the product’s compliance with the requirements of regulatory documents.
Reducing the volume of tests (controlled indicators of regulatory documents) of medicines produced by domestic manufacturing enterprises and foreign manufacturing companies, and which have no complaints about the quality of the products, is allowed only in agreement with the federal executive body in the field of healthcare.
The results of this assessment are reflected in the expert’s report. Based this conclusion The certification body decides to issue a certificate of conformity, issues the certificate and registers it.
If the results of the conformity assessment of medicinal products are negative, the certification body issues a reasoned decision to refuse to issue a certificate.
9. Inspection control of certified products
9.1. Inspection control over certified products is carried out (if provided for by the certification scheme) during the entire validity period of the certificate once every 6 months in the form of periodic and unscheduled inspections, including testing of samples of medicines and other actions necessary to confirm that the products produced and sold continue to meet established requirements confirmed during certification.
9.2. Inspection control consists of the following stages:
development of an inspection program;
analysis of incoming information about certified products;
sampling, testing and analysis of their results;
registration of control results and decision-making.
9.3. Unscheduled inspections are carried out in cases where information about claims to the quality of medicines is received from consumers, trade enterprises, medical institutions, as well as bodies implementing state control and supervision of products for which the certificate is issued.
9.4. The results of inspection control are documented in an act. The certificate is stored in the certification body, and its copies are sent to the manufacturer (seller) and to the organizations that took part in the inspection control.
9.5. Based on the results of inspection control, the certification body may suspend or cancel the certificate in case of non-compliance of medicinal products with the requirements of regulatory documents.
Information about the suspension or cancellation of a certificate is brought to the attention of the federal executive body in the field of healthcare, consumers and other interested participants in the certification system. The procedure and deadlines for providing this information are established by the federal executive body in the field of healthcare.
10. Certification bodies send to the central body of the System, within the established time frame, information on the results of certification and information on the conduct of inspection control.
11. Providing certification bodies and testing laboratories with regulatory documents is the responsibility of the federal executive body in the field of healthcare.
Trade secret.
3. The drug certification body maintains a registration and recording system in working order. Registration records must reflect the certification procedure for medicines.
4. The certification body for medicines keeps records of certificates issued by it in the prescribed manner and sends information about them to Central authority on certification of medicines.
5. The maintenance of the register of certified medicines is carried out by certification bodies, which send the relevant information to the Central Authority for maintaining a consolidated register of certified medicines in the Russian Federation.
IV. Testing laboratories
1. Testing laboratories (centers) accredited in the established manner, regardless of their organizational and legal forms and forms of ownership, that meet the established requirements and are independent of the manufacturer (seller) and consumer (buyer) are allowed to carry out testing of medicinal products for certification purposes.
2. The activities of testing laboratories in the field of certification of medicines are carried out on the basis of accreditation certificates issued in the prescribed manner.
3. The testing laboratory tests medicines of domestic and foreign production in strict accordance with the requirements of regulatory documents approved by the federal executive body in the field of healthcare.
V. Consideration of appeals
1. If any controversial issues And conflict situations between certification participants within the System, the interested party(ies) may file an appeal to the appeal commission of the federal executive body in the field of healthcare.
2. Decisions of certification bodies and the appeal commission may be appealed in court in the prescribed manner.
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1. Confirmation state registration medicinal product carried out upon issuance of a perpetual registration certificate for a medicinal product in the case specified in Part 2 of Article 28 of this Federal Law, within a period not exceeding sixty working days from the date of receipt by the relevant authorized federal executive body of an application to confirm the state registration of the medicinal product. Confirmation of state registration is not carried out in relation to a medicinal product that has not been in circulation in the Russian Federation for three or more years, as well as in relation to a medicinal product produced in violation of the requirement established by part 3.7 of Article 71
2. An application for confirmation of state registration of a medicinal product for medical use is submitted to the relevant authorized federal executive body no earlier than one hundred and eighty days before the expiration of the registration certificate of the medicinal product for medical use.
(see text in the previous edition)
2.1. An application for confirmation of state registration of a medicinal product for veterinary use is submitted to the relevant authorized federal executive body no earlier than one hundred and eighty days before the expiration of the registration certificate of the medicinal product for veterinary use and no later than the expiration of its validity.
3. Confirmation of state registration of a medicinal product is carried out based on the results of an examination of the ratio of expected benefit to possible risk use of a medicinal product based on the results of monitoring the effectiveness and safety of the medicinal product, carried out by the holder or owner of the registration certificate of the medicinal product or a legal entity authorized by them, as well as the relevant authorized federal executive body in accordance with the requirements of Article 64 of this Federal Law.
4. The following shall be attached to the application for confirmation of state registration of a medicinal product for medical use:
1) documents containing the results of monitoring the effectiveness and safety of a medicinal product for medical use, carried out by the holder or owner of the registration certificate of a medicinal product for medical use or a legal entity authorized by it, in a form approved by the authorized federal executive body;
2) a copy of the license for the production of medicinal products or a copy of the conclusion on the compliance of the medicinal product manufacturer with the requirements of the rules of good manufacturing practice issued by the authorized federal executive body in relation to the production site of a medicinal product for medical use, the state registration of which is confirmed if the production of the medicinal product is for medical use is carried out in the Russian Federation;
3) a copy of the license issued by the authorized body of the country of manufacture for the production of a medicinal product for medical use and its translation into Russian, certified in the prescribed manner, as well as a copy of the conclusion on the compliance of the medicinal product manufacturer with the requirements of the rules of good manufacturing practice, issued by the authorized federal executive body in in relation to the production site of a medicinal product for medical use, the state registration of which is confirmed, or a copy of the decision of the authorized federal executive body to conduct an inspection of the manufacturer of medicinal products if the production of the medicinal product for medical use is carried out outside the Russian Federation.
(see text in the previous edition)
4.1. In relation to biological medicinal products for medical use, the applicant additionally presents the results of the measures provided for in the risk management plan approved by the authorized federal executive body when carrying out state registration of the medicinal product for medical use.
4.2. The application for confirmation of state registration of a medicinal product for veterinary use is accompanied by documents containing the results of monitoring the effectiveness and safety of the medicinal product for veterinary use, carried out by the holder or owner of the registration certificate of the medicinal product for veterinary use or a legal entity authorized by him, in a form approved by the authorized federal body executive power, and the documents specified in paragraphs 1, - 2.2, subparagraphs “a”, “b”, “k”, “l” of paragraph 4 of part 3 of article 17 of this Federal Law. In relation to immunobiological medicinal products for veterinary use, the information specified in subparagraph “k” of paragraph 4 of part 3 of Article 17 of this Federal Law is not provided. In relation to medicinal products for veterinary use obtained with the use of genetically modified organisms or containing such organisms, the information specified in paragraph 13 of part 3 of article 17 of this Federal Law is additionally provided.
(see text in the previous edition)
4.3. With an application for confirmation of state registration of a medicinal product, the applicant submits a copy of the document confirming payment of the state fee for confirmation of state registration of the medicinal product, or may submit the specified document on his own initiative. In case of failure to submit the specified document, the authorized federal executive body verifies the fact of payment of the state duty by the applicant by using information on the payment of the state duty contained in the State Information System on State and Municipal Payments, based on the copy of the document submitted by the applicant confirming the payment of the state duty.
5. Within ten working days from the date of acceptance of the application for confirmation of state registration of the medicinal product and documents containing the results of monitoring the effectiveness and safety of the medicinal product carried out by the holder or owner of the registration certificate of the medicinal product or a legal entity authorized by them, the authorized federal executive body:
1) checks the completeness of the information contained in the documents submitted by the applicant;
2) makes a decision to conduct or refuse to conduct an examination of the relationship between the expected benefit and the possible risk of using the medicinal product based on the results of monitoring the effectiveness and safety of the medicinal product, carried out by the holder or owner of the registration certificate of the medicinal product or a legal entity authorized by them, as well as the federal executive body authorities in accordance with the requirements of Article 64 of this Federal Law;
3) notifies the applicant and the expert institution in electronic form or in writing about the decision taken or if a decision is made to refuse to conduct an examination, indicate the reasons for such refusal.
6. If it is revealed that the information contained in the documents submitted by the applicant is unreliable and (or) insufficient, the authorized federal executive body sends the applicant a request to clarify the specified information. The request of the authorized federal executive body may be submitted to the authorized representative of the applicant in person against signature, sent by registered mail or transmitted electronically via telecommunication channels. If a request from an authorized federal executive body is sent by registered mail, it is considered received after six days from the date of sending the registered letter.
7. The applicant is obliged to submit a response to the request of the authorized federal executive body within a period not exceeding ninety working days from the date of its receipt. The period specified in Part 5 of this article is suspended from the day the request is sent to the applicant by the authorized federal executive body until the day it receives the corresponding response and is not taken into account when calculating the period for confirming the state registration of the medicinal product.
8. The basis for refusal to conduct an examination of the relationship between the expected benefit and the possible risk of using a medicinal product is the submission of documents containing the results of monitoring the effectiveness and safety of the medicinal product, and (or) in relation to biological medicinal products, the results of the implementation of measures in accordance with the risk management plan approved by the authorized federal executive body when carrying out the state registration of a medicinal product, incompletely, the absence of information confirming the fact of payment of the state duty for confirmation of the state registration of the medicinal product, or the applicant’s failure to provide a response within the prescribed period to the request of the authorized federal executive body specified in Part 6 of this article authorities, as well as the lack of information in these documents that should be reflected in them.
9. An examination of the ratio of the expected benefit to the possible risk of using a medicinal product in order to confirm the state registration of the medicinal product is carried out by a commission of experts of an expert institution within a period not exceeding forty working days.
10. If the materials provided to the expert are insufficient to give an opinion, the expert applies to the head of the expert institution to provide him with necessary materials. The head of the expert institution submits a corresponding request to the authorized federal executive body that issued the assignment to conduct an examination of the relationship between the expected benefit and the possible risk of using the medicinal product on the basis of a document containing the results of monitoring the effectiveness and safety of the medicinal product. Within five working days from the date of receipt of the request from the head of the expert institution, the specified federal executive body sends the applicant a request to provide the necessary materials, which can be transferred to the authorized representative of the applicant in person against signature, sent by registered mail or transmitted electronically via telecommunication channels . If a request from an authorized federal executive body is sent by registered mail, it is considered received after six days from the date of sending the registered letter.
11. The applicant is obliged to submit a response to the request of the authorized federal executive body within a period not exceeding sixty working days from the date of receipt of the specified request. The authorized federal executive body that issued the assignment to conduct an examination of the relationship between the expected benefit and the possible risk of using a medicinal product on the basis of a document containing the results of monitoring the effectiveness and safety of the medicinal product, within five working days from the date of receipt from the applicant of a response to the request of the authorized federal executive body the authorities forward this response to the expert institution. If, after sixty working days, the applicant fails to provide a response to the specified request, the authorized federal executive body that issued the assignment to conduct an examination of the relationship between the expected benefit and the possible risk of using the medicinal product on the basis of a document containing the results of monitoring the effectiveness and safety of the medicinal product, within five working days days sends a notification to the expert institution about the applicant’s failure to provide a response to the request of the specified body. The time from the date of sending the request of the expert institution to the authorized federal executive body until the day the expert institution receives a response to the request or notification of failure to provide a response to the request is not taken into account when calculating the period for conducting an examination of the ratio of the expected benefit to the possible risk of using a medicinal product on the basis of a document containing the results monitoring the effectiveness and safety of the drug.
13. The basis for refusal to confirm the state registration of a medicinal product is the conclusion of the relevant authorized federal executive body that the risk of harm to human or animal health as a result of taking the medicinal product exceeds the effectiveness of its use.
(see text in the previous edition)
14. During the procedure for confirming the state registration of a medicinal product, its circulation in the Russian Federation is not suspended.
15. It is allowed to circulate medicinal products before the expiration date, produced within one hundred and eighty calendar days after the date of the decision by the authorized federal executive body to confirm state registration, in accordance with the information contained in the documents of the registration dossier for the medicinal product before the date of such decision.
(see text in the previous edition)
Confirmation of compliance of drugs with the requirements imposed by current legislation is mandatory.
The Government of the Russian Federation approved (Resolution of the Government of the Russian Federation dated December 1, 2009 No. 982 (as amended on October 20, 2014):
- · Unified list of products subject to mandatory certification;
- · A unified list of products, confirmation of conformity of which is carried out in the form of a declaration of conformity.
According to this document confirmation of compliance in the form subject to mandatory certification:
· medical immunobiological preparations;
Confirmation of conformity in the declaration form are subject to drugs registered in the prescribed manner and consisting of mixed or unmixed products for use for therapeutic purposes, packaged in dosage forms or in packaging for retail sale (codes 931000-937000 of the All-Russian Product Classifier OK 005-93).
The following are not subject to declaration:
- · Medicines manufactured in pharmacies according to doctors’ prescriptions and requirements medical organizations;
- · in-pharmacy preparation;
- · drug substances intended for carrying out clinical trials;
- · substances intended for drug registration.
Declaration of Conformity- this is a document certifying the compliance of products released into circulation with the requirements of technical regulations (Federal Law of the Russian Federation No. 184 “On Technical Regulation”).
The declaration process involves the participation of 3 parties:
- · certification body,
- · accredited testing laboratory,
- · declarant (manufacturer or supplier).
Today in the Russian Federation there are 7 drug certification bodies accredited in accordance with the established procedure (4 in Moscow, St. Petersburg, Yekaterinburg, Novosibirsk), which register declarations of conformity and about 70 technically competent and independent testing laboratories accredited to conduct drug testing for the purposes of declaration of conformity.
When confirming compliance in the declaration form, the Declarant independently:
- · selects a testing laboratory and certification body that registers declarations of conformity;
- · carries out the selection of samples for examination (or may entrust the selection of samples on a contractual basis to a testing laboratory or certification body).
The declaration of conformity of drugs is accepted by 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 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.
Types of evidence:
- · own evidence:
- 1. passport (analysis protocol) of the manufacturer (for domestic drugs);
- 2. company quality certificate (for foreign drugs);
- 3. documents confirming the origin of the medicine;
- 4. protocols of incoming control (testing) for raw materials, intermediate products, substances and materials used in the production of drugs;
- 5. documents confirming the origin of the raw materials used in the production of this drug.
- evidence involving a third party:
- - with the participation of an accredited testing laboratory: test reports carried out according to quality and safety indicators established in regulatory documentation for this drug;
- - with the participation of the certification body: certificates of conformity issued for production or quality management system (QMS), certified in the GOST R Certification System.
The declaration of conformity of a drug accepted by the manufacturer (seller) is subject to registration with a certification body accredited in the prescribed manner. Registration is of an application nature. The declaration of conformity must have two seals - the seal of the certification body and the seal of the organization for which the declaration is issued. The register of registered declarations of conformity is maintained by the certification body. The declaration of conformity can be sent for registration to only one certification body at the choice of the manufacturer (seller). medicinal pharmacy quality pharmaceutical
A declaration of conformity is accepted for each series (batch) of drugs released into circulation. The Declaration of Conformity is accepted for the period established by the manufacturer (seller) of the drug, but not longer than the established shelf life of the drug. Providing copies of declarations of conformity is not provided. Information about the declaration of conformity is indicated in the accompanying documentation for the product.
Currently, in accordance with Art. 28 Federal Law No. 184-FZ “On Technical Regulation” establishes the obligation of persons who are applicants (seller of products) to present to interested parties documents confirming the conformity of products with established requirements (declarations of conformity or copies thereof). At the same time, interested parties may be Centers for quality control and certification of drugs in the constituent entities of the Russian Federation, wholesale pharmaceutical organizations, retail pharmacy organizations, as well as consumers.
System for confirming the conformity of medicines, medical products regulatory requirements for quality Lecture for 4th year students of the Federal State Budgetary Educational Institution of Higher Education 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 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 Federal law dated 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 (a legal entity or 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 (testing) 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 the quality and safety indicators established in the 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 declarations 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 circulation on the market 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 Dietary supplements + radionuclide test protocol Perfume, cosmetics and oral care products Declaration of conformity (Certificate of Conformity GOST R with reference to the sanitary-epidemiological report) 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
