Certification of medicines and preparations. Certification of medicines Certified medicines

1. Confirmation of the state registration of a medicinal product is carried out upon issuance of an indefinite registration certificate medicinal product in the case specified in paragraph 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 for confirmation of the state registration of the medicinal product. Confirmation of state registration is not carried out in respect of a medicinal product that was not in circulation in Russian Federation for three or more years, as well as in relation to a medicinal product manufactured in violation of the requirement established by part 3.7 of Article 71

2. Application for confirmation of the state registration of a medicinal product for medical use submitted to the appropriate authorized federal executive body not earlier than one hundred and eighty days before the expiration of the registration certificate of the medicinal product for medical use.

(see text in previous edition)

2.1. An application for confirmation of state registration of a medicinal product for veterinary use shall be submitted to the relevant authorized federal executive body not earlier than one hundred and eighty days before the expiration of the registration certificate for a medicinal product for veterinary use and no later than its expiration date.

3. Confirmation of the state registration of a medicinal product is carried out based on the results of an examination of the ratio of the expected benefit to possible risk use of the medicinal product based on the results of monitoring the efficacy and safety of the medicinal product, carried out by the holder or owner of the registration certificate of the medicinal product or authorized by them legal entity, as well as the relevant authorized federal executive body in accordance with the requirements of Article 64 of this Federal Law.

4. An application for confirmation of state registration of a medicinal product for medical use shall be accompanied by:

1) documents containing the results of monitoring the effectiveness and safety of the medicinal product for medical use, conducted by the holder or owner of the registration certificate of the medicinal product for medical use or a legal entity authorized by him, in the form approved by the authorized federal executive body;

2) copy of production license medicines or a copy of the opinion on the compliance of the manufacturer of medicinal products with the requirements of the rules of good manufacturing practice issued by the authorized federal executive body in relation to the production site of the medicinal product for medical use, the state registration of which is confirmed if the production of the medicinal product for medical use is carried out in the Russian Federation;

3) a copy of the license issued by the authorized body of the manufacturer's country for the production of a medicinal product for medical use and its translation into Russian, duly certified, as well as a copy of the conclusion on the compliance of the manufacturer of medicinal products 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 the 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 previous edition)

4.1. With regard to biological medicinal products for medical use, the applicant additionally submits the results of the measures provided for by the risk management plan approved by the authorized federal executive body during the state registration of the medicinal product for medical use.

4.2. The application for confirmation of the state registration of a medicinal product for veterinary use shall be accompanied by documents containing the results of monitoring the efficacy and safety of the medicinal product for veterinary use, carried out by the holder or owner of the registration certificate for the medicinal product for veterinary use or by a legal entity authorized by him, in the 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. With regard 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 shall not be provided. With regard to medicinal products for veterinary use obtained using genetically modified organisms or containing such organisms, the information specified in Clause 13 of Part 3 of Article 17 of this Federal Law shall be additionally provided.

(see text in previous edition)

4.3. With an application for confirmation of the state registration of a medicinal product, the applicant submits a copy of the document confirming the payment of the state fee for confirmation of the state registration of the medicinal product, or may submit this document on his own initiative. In case of failure to submit the specified document, the authorized federal executive body checks the fact of payment of the state fee by the applicant by using the information on the payment of the state fee contained in the State information system on state and municipal payments, on the basis of a copy of the document submitted by the applicant confirming the payment of the state fee.

5. Within ten working days from the date of acceptance of the application for confirmation of the state registration of the medicinal product and documents containing the results of monitoring the efficacy and safety of the medicinal product, conducted 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 ratio of the expected benefit to the possible risk of using the medicinal product based on the results of monitoring the efficacy and safety of the medicinal product, conducted 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) notify in electronic form or in writing the applicant and the expert institution of decision or in the event of a decision to refuse to conduct an examination, indicate the reasons for such a refusal.

6. If unreliability and (or) insufficiency of the information contained in the documents submitted by the applicant is revealed, the authorized federal executive body sends the applicant a request for clarification of the specified information. The request of the authorized federal executive body may be handed over to the authorized representative of the applicant in person against receipt, sent by registered mail or transmitted electronically via telecommunication channels. If the request of the authorized federal executive body is sent by registered mail, it shall be deemed 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 shall be suspended from the day the request is sent to the applicant by the authorized federal executive body until the day he receives the appropriate 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 ratio of the expected benefit to the possible risk of using the medicinal product is the submission of documents containing the results of monitoring the efficacy 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 in the course of the state registration of the medicinal product, in an incomplete volume, the lack of information confirming the fact of payment of the state fee for confirmation of the state registration of the medicinal product, or the applicant’s failure to provide a response to the request of the authorized federal executive body specified in Part 6 of this Article authorities, as well as the absence in these documents of information that should be reflected in them.

9. Examination of the ratio of the expected benefit to the possible risk of using the medicinal product in order to confirm the state registration of the medicinal product is carried out by a commission of experts of the expert institution within a period not exceeding forty working days.

10. In case of insufficiency of the materials submitted to the expert for giving an opinion, the expert shall apply to the head of the expert institution to provide him necessary materials. The head of the expert institution shall submit a relevant request to the authorized federal executive body that issued the task to conduct an examination of the ratio of the expected benefit to 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 of the head of the expert institution, the specified federal executive body sends the applicant a request for the submission of the necessary materials, which can be transferred to the authorized representative of the applicant personally against receipt, sent by registered mail or transmitted electronically via telecommunication channels. . If the request of the authorized federal executive body is sent by registered mail, it shall be deemed 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 said request. The authorized federal executive body that issued the order to conduct an examination of the ratio of the expected benefit to the possible risk of using the medicinal product on the basis of a document containing the results of monitoring the efficacy 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 authorities sends this answer to the expert institution. If, after sixty working days, the applicant fails to provide a response to this request, the authorized federal executive body that issued the assignment for conducting an examination of the ratio of the expected benefit to the possible risk of using the medicinal product on the basis of a document containing the results of monitoring the efficacy 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 day the request of the expert institution was sent to the authorized federal executive body until the day the expert institution received 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 the medicinal product on the basis of a document containing the results monitoring the efficacy and safety of the medicinal product.

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 previous edition)

14. During the period of 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 the state registration, in accordance with the information contained in the documents of the registration dossier for the medicinal product before the date of such a decision. .

(see text in previous edition)

Certification of medicinal products is intended to prevent the possibility of substandard or dangerous medical products reaching the consumer. Certificates are issued for medical preparations only by authorized certification centers accredited in this area. One of such companies is our certification center Expert-Test. With our professional help, certification of the quality of medicines will be a simple procedure for you.

Conformity assessment features

To drugs medical purpose include medicines of artificial and natural origin, which can be produced in the form of mixtures, tablets, solutions, ointments, and so on. Certification of medical products is mandatory for drugs intended for anesthesia, radiopaque drugs, psychotropic, narcotic and other substances.

To find out in detail about what kind of permit document you need to order and issue for your products, please contact the specialists of our expert center for advice. In the shortest possible time, you can order a TR CU certificate, a declaration of conformity, as well as other permits at an affordable price in Moscow from us.

The price for certification of medical products will depend on several factors, but the main criterion determining the cost of specialist services is the complexity of the product conformity assessment procedure in Moscow or other regions of the country. The list of medical products subject to such a procedure as certification of the quality of medical products is regulated by the Decree of the State Standard of the Russian Federation No. 60, and is also indicated in the Letter of the State Committee for Standardization and Metrology dated January 15, 2003.

How permits are issued

Certificates for medicines are issued only after laboratory testing of the sample in a special research laboratory. Only those laboratories that are accredited by Rosstandart can conduct laboratory tests of medicines.

In order to immediately start issuing a certificate of conformity with GOST R or other required documents products, you can seek professional help from us. Here you can apply, buy and obtain all the necessary permits that are required for the legal sale of medical products in Russia.

Company Expert-Test for reasonable prices provides a wide range of services in Moscow for conformity assessment various kinds products to the requirements of relevant standards and regulations. You can buy a TR CU declaration, a certificate or a letter of refusal from us for almost any type of product. We provide professional certification services not only in Moscow and the region, but throughout Russia.

Falsification of drugs in modern pharmaceuticals is not uncommon. By purchasing low-quality medicine, the consumer not only does not get rid of the existing disease, but it is also likely to be poisoned. How to protect yourself from buying a fake? One of the most reliable options in this case would be to check whether the drug has a certificate of conformity.

Certification of medicines on the territory of the Russian Federation is considered a mandatory procedure.

One can talk about the quality of medicines only if there are four types of certification documents:

• Certificate of Conformity. This version of the permit document confirms the compliance of the quality of medicines with the requirements of GOST;
• The registration certificate allows you to sell medicines on the territory of all subjects of the Russian Federation;
• Production certificate - confirms the fact that in the process of manufacturing medicines in pharmacological production, quality control is carried out in accordance with established requirements;
• A certificate of a medicinal product that confirms its quality for the purpose of further export from the country.

AT modern conditions Russian market quality control and certification of medicines are of great importance. The increase in the price of medicines leads to the activation of their handicraft production and an increase in the level of falsification. The need for certification for medications arises also because the proportion of marriage has greatly increased in the pharmacological production.

When buying drugs at a pharmacy, the consumer has every right to ask for a sanitary and epidemiological conclusion. It is necessary to issue a certificate for medicinal products imported into Russia from abroad.

It is possible to obtain a permit document for medical preparations at the ACM Certification Center only if the results of the examination of the samples obtained in the conditions of an accredited laboratory meet the quality requirements.

The procedure for obtaining a certificate for any type of medicinal products is as follows:

• The manufacturer submits an application to our certification center;
• Responsible and qualified employees of the organization analyze the application and the submitted documents;
• Next is drawn up detailed diagram certification;
• In the laboratory conditions, a thorough check of samples of medicinal products provided by the manufacturer is carried out;
• The research results and technical documentation are analyzed;
• Employees of the certification center make a decision on the issuance of permits for medicines or refusal;
• Carrying out the procedure for issuing a certificate;
• Inspection of certified medicines already in circulation;
• Performance corrective work aimed at bringing finished medicinal products to the required standards.

If you want to quickly and efficiently issue a certificate of conformity for medicinal products, contact . Our specialists will do everything possible so that you can obtain the necessary permits in a short time. Employees of our certification center for a long time engaged in the preparation of documents for pharmaceutical products. By contacting us by phone, you can get comprehensive information regarding certification of medicines . We are ready to provide you with qualified assistance in obtaining a certificate of conformity for any type of pharmaceutical products.

These Rules define the basic principles and requirements related to the procedure for certification of registered in State Register medicines of domestic and foreign production in order to protect the rights and interests of consumers and conduct a unified public policy in the field of providing the population with high-quality medicines.

II. Order mandatory certification medicines

1. General requirements to the procedure for mandatory certification of medicines are established by the Procedure for Certification of Products in the Russian Federation (Resolution of the State Standard of the Russian Federation of September 21, 1994 N 15) with Amendment N 1 of the Procedure for Certification of Products in the Russian Federation (Resolution of the State Standard of the Russian Federation of 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 N 14 of July 25, 1996).

2. The certificate of conformity of the medicinal product is issued by the certification bodies of medicinal products after checking the medicinal product for compliance with the requirements normative documents, approved by the federal executive body in the field of healthcare, on the applicant.

The validity period of the certificate for a batch (series) of medicinal products is not established. The certificate is valid for the delivery, sale of a batch of products during the shelf life of the medicinal product, established by regulatory documents.

3. Bodies for the certification of medicines must use the test results issued by any testing laboratory accredited in the prescribed manner, in the event that 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:

Submission of an application to the certification body;

Consideration 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 it is provided for by the certification scheme;

Analysis of the results of tests, inspections and decision-making on the issuance (refusal to issue) a certificate of conformity;

Registration and issuance of a certificate of conformity;

Implementation of inspection control over certified products (if it is provided for by the certification scheme);

Corrective actions in case of violation of product compliance with established requirements and incorrect application of the mark of conformity;

Information about certification results.

6. To carry out work on the certification of medicines, the applicant sends an application to the certification body.

7. The certification body considers 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 for the certification of medicines and test methods approved by the federal executive body in the field of healthcare.

Tests of medicinal products of domestic and foreign production during certification should be carried out only according to regulatory documents approved by the federal executive body in the field of healthcare (general pharmacopoeia articles, pharmacopoeial articles, pharmacopoeial articles of enterprises, regulatory documents for foreign-made medicines).

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. Sampling is carried out at the warehouse of the applicant in the amount necessary to conduct 3 analyzes for all indicators provided for by regulatory documents.

8.4. Sampling is formalized by an act. The selected samples are isolated from the main products, packed, sealed or sealed at the place of sampling. The release of selected samples (samples) of medicinal products is issued 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 authority in the field of healthcare. Identification is carried out: for belonging to the declared party; 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 package, by evaluating the indicators "description", "packaging", "labeling".

When identifying by the certification body, the following documents are considered:

A copy of the license for the right to manufacture (sale) of medicines, certified by a notary;

The manufacturer's analysis protocol (for domestic medicinal products) or the company's analysis certificate and its translation (for foreign medicinal products) with the results of checking the quality of medicinal products for compliance with the requirements of regulatory documents upon release;

A document confirming the origin (acquisition) of medicines;

Documented information on the quantity of the medicinal product being certified.

The applicant, in order to reduce the period of work on certification, submits the documents considered during the identification of medicinal products simultaneously with the filing of the application.

If, based on the results of product identification, it is established 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 performed.

8.6. Medicinal product samples are transferred by the certification body to the testing laboratory with an appropriate referral indicating the types of required certification tests and a copy of the drug sample (sampling) act.

Samples of medicinal products remaining from the 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 the execution of a transfer certificate, those that do not satisfy are destroyed with execution of the act of destruction. Requirements for marking and accounting of samples are established in the documents of the certification body.

8.7. The test results are drawn up in the form of a test report, which must reflect the actual data of the experimental verification, 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 duplicate is submitted to the certification body or, if the applicant applied directly to the testing laboratory in order to conduct tests on all indicators of regulatory documents - to the applicant. Test reports are subject to storage during the entire shelf life of the medicinal product.

8.8. In the event of a discrepancy between the quality of medicines and the requirements of regulatory documents, the testing laboratory sends a conclusion with the test report to the certification body for medicines and the federal executive body in the field of healthcare.

The terms of storage of test protocols for medicinal products, the quality of which does not meet the requirements of regulatory documents, are established for testing laboratories by the federal executive body in the field of health care, but cannot be less than 6 months.

Information on the identification of non-compliance of a medicinal product with the requirements of a regulatory document during certification is sent by the certification body of medicinal products 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, it is recommended that samples of these medicinal products with accompanying documents be sent to the Institute for State Control of Medicines. Samples of medicinal products are sent for testing in the amount necessary to conduct 3 analyzes for all indicators provided for by regulatory documents, including testing for microbiological purity, with a cover letter, a sampling report, an original or a certified copy of the analysis protocol carried out by the manufacturer.

8.9. The certification body, after product identification, analysis of test reports, certification of the quality system (production) (if it is established by the certification scheme) and analysis of the submitted documents, assesses the compliance of medicines with regulatory documents. The test results must fully and reliably confirm the compliance of products with the requirements of regulatory documents.

It is allowed to reduce the scope of tests (controlled indicators of regulatory documents) of medicines manufactured by domestic manufacturers and foreign manufacturers, and which do not have claims to the quality of their 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 opinion. Based on this conclusion, the certification body decides to issue a certificate of conformity, draws up a certificate and registers it.

In case of negative results of the conformity assessment of medicines, the certification body issues a reasoned decision to refuse to issue a certificate.

9. Inspection control over certified products

9.1. Inspection control over certified products is carried out (if it is 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 manufactured and sold products continue to comply with the 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 of receipt of information about claims to the quality of medicines from consumers, trade enterprises, medical institutions, as well as bodies that carry out state control and supervision of the products for which the certificate is issued.

9.4. The results of inspection control are documented in an act. The act 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 the 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 on the suspension or cancellation of the 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 terms for communicating this information are established by the federal executive body in the field of healthcare.

10. Certification bodies send information on the results of certification and information on the conduct of inspection control to the central body of the System in a timely manner.

11. The provision of certification bodies and testing laboratories with regulatory documents is entrusted to the federal executive body in the field of healthcare.

Trade secret.

3. The drug certification body maintains the registration and recording system in working order. Registration records should reflect the procedure for certification of medicines.

4. The drug certification body keeps records of the certificates issued by it in accordance with the established procedure and sends information about them to central authority for the certification of medicines.

5. Maintaining the register of certified medicinal products is carried out by certification bodies that send relevant information to the Central Authority for maintaining a consolidated register of certified medicinal products in the Russian Federation.

IV. Test laboratories

1. Testing laboratories (centers) accredited in accordance with the established procedure, 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 tests 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 carries out tests of domestic and foreign medicines 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. In case of disputes and conflict situations between certification participants within the System, the interested party(s) may (may) file an appeal with the Appeal Commission of the federal executive body in the field of healthcare.

2. Decisions of the certification bodies, the appeal commission may be appealed in court in accordance with the established procedure.

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