ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of April 3, 2020 No. 430

About features of the address of medical products, including state registration of series (batch) of medical product

According to part 5.1 of article 38 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" and Item 2 of part 1 of article 17 of the Federal law "About Modification of Separate Legal Acts of the Russian Federation concerning the Prevention and Liquidation of Emergency Situations" Government of the Russian Federation decides:

1. Approve the enclosed features of the address of medical products, including state registration of series (batch) of medical product.

2. This resolution becomes effective from the date of its official publication and is effective till January 1, 2028.

Approved by the Order of the Government of the Russian Federation of April 3, 2020 No. 430

Features of the address of medical products, including state registration of series (batch) of medical product

1. This document is applied in case of the address of medical products which are intended for application in the conditions of military operations, emergency situations, the prevention of emergency situations, prevention and treatment of the diseases constituting danger to the people around, diseases and defeats received as a result of impact of adverse chemical, biological, radiation factors according to the list according to appendix No. 1 (further - medical product), including state registration of series (batch) of medical product.

2. The registration certificate on series (batch) of medical product is issued valid through January 1, 2028.

3. For state registration of medical product the developer, the producer (manufacturer) of medical product, the authorized representative of the producer (manufacturer) or person performing import of medical product to the Russian Federation for the purpose of its state registration (further - the applicant), represents or sends to the federal state budgetary institutions which are under authority of the Federal Service on supervision in health sector (further - expert organization), in electronic form and (or) on paper:

the statement for state registration of medical product according to requirements of Item 9 of Rules of state registration of the medical products approved by the order of the Government of the Russian Federation of December 27, 2012 No. 1416 "About approval of Rules of state registration of medical products" (further - Rules of registration);

the copy of the document confirming powers of the authorized representative of the producer (manufacturer) (in the presence);

the documents confirming accessory of series (batch) of medical product to the applicant on legal causes;

technical documentation of the producer (manufacturer) on medical product (in the presence);

the operational documentation of the producer (manufacturer) on medical product conforming to the requirements approved by the Ministry of Health of the Russian Federation;

photographic images of general view of medical product together with the accessories necessary for application of medical product to destination (the size at least 18 by 24 centimeters);

the documents confirming results of technical testing of medical product, toxicological researches of medical product which use assumes availability of contact with human body, the clinical testing of medical product which are carried out according to the standard program of testing depending on type of medical product developed by expert organization (further - the standard program), and published on the official sites of expert organizations on the Internet (on applicability). In case of carrying out in the Russian Federation testing (researches) on the program, excellent from standard, the expert organization determines sufficiency of such researches (testing) for the purposes of state registration of series (batch) of medical products according to this document;

other documents characterizing quality, efficiency and safety of medical product (in the presence);

list of documents.

If the specified documents are constituted in foreign language, they are represented with the translation into Russian certified by the applicant.

The requirements established by the Ministry of Health of the Russian Federation about evaluating compliance of medical products in the form of technical testing, toxicological researches, clinical testing for the purpose of state registration of medical products, are not obligatory for testing (researches) of the medical products included in the list. This provision is applied before liquidation of threat of emergence of emergency situation or liquidation of emergency situation. The medical products which did not undergo the specified assessment of conformity are subject to repeated registration in accordance with the legislation of the Russian Federation.

4. The expert organization within 3 working days from the date of receipt of the documents specified in Item 3 of this document carries out assessment of their completeness, sufficiency and completeness, including sufficiency of amount of the carried-out testing (researches) of medical products for the purposes of state registration of series (batch) of medical products according to this document, draws up the conclusion about possibility (impossibility) of state registration of series (batch) of medical products in the form established by the Ministry of Health of the Russian Federation for the purposes of examination of quality, efficiency and safety of medical product and sends it to the Federal Service on supervision in health sector.

The documents submitted by the applicant according to Item 3 of this document are attached to the conclusion of expert organization.

In case of insufficiency for pronouncement of the conclusion of materials by expert organization and the data containing in the documents submitted by the applicant, sends stipulated in Item 3 this documents, expert organization within 2 working days from the date of receipt of the specified documents to the applicant the registered mail with the assurance of receipt or in electronic form, signed by the digital signature, or electronically on telecommunication channels request about submission of necessary data with indication of nature of notes and method of their elimination (further - request).

The applicant shall submit the reply to the request of expert organization in time which is not exceeding 5 working days from the date of receipt of request. The expert organization prepares the conclusion within 2 working days from the date of receipt from the applicant of reply to the request.

In case of non-presentation after 5 working days by the applicant of reply to the request the expert organization prepares the conclusion based on the documents which are available at its order.

5. The conclusion about impossibility of state registration of series (batch) of medical products is drawn up by expert organization in the presence of the following bases (one or several):

a) there are no proofs of compliance of medical product to requirements of documentation of the producer (manufacturer);

b) there are no proofs of safety of medical product;

c) quality, and (or) efficiency, and (or) safety of medical product are not confirmed with the obtained data;

d) the risk of damnification to health of citizens and health workers owing to application of medical product exceeds efficiency of its application;

e) the medical product is absent in the list provided by appendix No. 1 to this document;

e) the documents specified in Item 3 of this document are not provided in full.

6. The Federal Service on supervision in health sector within 2 working days from the date of receipt of the conclusion specified in item 4 of these features:

a) makes the decision on state registration of series (batch) of medical product which is drawn up by the order of the Federal Service on supervision in health sector, directs to the applicant the registration certificate to medical product the registered mail with the assurance of receipt or in electronic form, signed by the digital signature, or electronically on telecommunication channels, enters in the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products, data on the registered series (batch) of medical product (in case of receipt of the conclusion about possibility of state registration of series (batch) of medical product);

b) makes the decision on refusal in state registration of series (batch) of medical product and directs to the applicant motivated refusal by the registered mail with the assurance of receipt or in electronic form, signed by the digital signature, or electronically on telecommunication channels (in case of receipt of the conclusion about impossibility of state registration of medical product).

7. The registration certificate on series (batch) of medical product is drawn up according to requirements of Item 56 of Rules of registration with indication of in it in addition the term of its action, number of series (batch) of medical product, serial numbers of medical products (in the presence).

7(1). Concerning the medical products specified in Items 1 - the 18th appendices No. 1 to this document, modification of the name of medical product regarding change of data on its serial number (in the presence), number of series (batch) is allowed if other data containing in documents of the registration file did not change.

7(2). For entering into the documents containing in the registration file, the changes specified in Item 7 (1) this document, the applicant represents (sends) to the Federal Service on supervision in health sector:

the statement for modification of the documents containing in the registration file (further - application for modification), issued according to Item 9 of Rules of registration;

the copy of the document confirming powers of the authorized representative of the producer (manufacturer) (in the presence);

the documents confirming accessory of series (batch) of medical product to the applicant on legal causes;

photographic images of general view of medical product together with the accessories necessary for application of medical product to destination (the size at least 18 by 24 centimeters);

the document of the producer, confirmatory that medical product with the declared serial numbers (in the presence), numbers of series (batch) to identically medical product registered originally according to this document;

original of the registration certificate;

list of documents.

If the specified documents are constituted in foreign language, they are represented with the translation into Russian certified by the applicant.

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