ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of June 2, 2020 No. 804

About modification in particular addresses of medical products, including state registration of series (batch) of medical product

The government of the Russian Federation decides:

1. Approve the enclosed changes which are made in particular the addresses of medical products, including state registration of series (batch) of medical product approved by the 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" (The official Internet portal of legal information (www.pravo.gov.ru), 2020, on April 6, No. 0001202004060033).

2. This resolution becomes effective from the date of its official publication.

Approved by the Order of the Government of the Russian Federation of June 2, 2020 No. 804

Changes which are made in particular addresses of medical products, including state registration of series (batch) of medical product

1. In Item 1 to "appendix" shall be replaced with words the word to "appendix No. 1".

2. To add the paragraph of the eighth of Item 3 after the words "In case of Carrying Out" with the words "in the Russian Federation".

3. Add item 4 with paragraphs of the following content:

"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.".

4. In the subitem "d" of Item 5 "appendix" shall be replaced with words the word "appendix No. 1".

5. Item 6 in paragraph one to replace figure "3" with figure "2".

6. Add with Items 7 (1) - 7(4) following contents:

"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 the field of health care:

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.

7(3). The statement for modification and documents, stipulated in Item 7(2) this documents, are represented by the applicant to the Federal Service on supervision in the field of health care on paper directly or go the registered mail with the assurance of receipt and the inventory of investment or in electronic form.

The Federal Service on supervision in the field of health care adopts the statement for modification and documents, stipulated in Item 7(2) this documents, according to the inventory.

7(4). Within 3 working days from the date of receipt of the statement for modification and documents, stipulated in Item 7(2) this documents, the Federal Service on supervision in the field of health care performs completeness and reliability of the data containing in them and performs:

a) decision making about modification of the documents containing in the registration file which is drawn up by the order of the Federal Service on supervision in the field of health care, entering into the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products, the corresponding data or decision making about return of the statement for modification and documents, stipulated in Item 7(2) this documents with motivated reasons for return reasons;

b) the notification in writing the applicant about the made decision the registered mail with the assurance of receipt with appendix of the renewed registration certificate (in case of modification of it) and earlier issued registration certificate with mark about its invalidity (with indication of date).".

7. In Item 8:

a) add the subitem "a" with words ", and also the statement for modification and documents, stipulated in Item 7(2) this documents";

b) add the subitem "g" with the words "and copies of the notifications which are drawn up by the Federal Service on supervision in the field of health care".

8. In Item 10:

a) the offer first of paragraph one to state in the following edition:

"10. Import to the Russian Federation without receipt of permission of the Federal Service on supervision in the field of health care of the unregistered medical products according to the list provided by appendix No. 1 to this document in the amount necessary for carrying out testing (researches), state registration and the subsequent realization is allowed.";

b) in the paragraph the second:

shall be replaced with words the words "Realization Is Allowed" "Import to the Russian Federation, realization, transportation, storage, application and utilization (destruction) are allowed";

"appendix" shall be replaced with words the word "appendix No. 1";

c) third to state the paragraph in the following edition:

"The applicant shall within 3 working days from the date of import to the Russian Federation of the unregistered medical products send to the Federal Service on supervision in the field of health care of the data on series (batches) of medical products according to appendix No. 2 to this document.";

d) the fifth to state the paragraph in the following edition:

"The applicant weekly, till January 1, 2021, concerning unregistered and registered according to this document and with Rules of registration of the medical products specified in Items 21 - the 30th appendices No. 1 to this document, sends to the Federal Service on supervision in the field of health care of the data according to appendix No. 2 to this document on their realization, about export from the territory of the Russian Federation or about destruction according to this document.".

9. To state appendix to the specified features in the following edition:

"Appendix No. 1

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