Modifications to the registration documents

If the applicant wishes to make modifications to the documents listed under subparagraph a of paragraph 54 of the Rules, the applicant must submit a request to Roszdravnadzor to introduce changes, accompanied with supporting documents confirming the respective changes.

If it is required to make modifications to documents listed in subparagraphs c and d of paragraph 10 of the Rules, the modifications can be introduced following the results of a expert examination similar to the quality, efficiency and safety tests of medical products for their state registration carried out in compliance with paragraph 21 of the Rules.

The Tax Code of the Russian Federation does not stipulate any state duty for making modifications to registration documents.

The grounds for an expert opinion on the impossibility of making modifications to the documents listed in subparagraphs c and d of paragraph 10 of the Rules are the following:

a) unauthenticity of the information provided to justify the modifications made;

b) lack of information confirming that the function and/or functional principle of the medical product remains unchanged following the modifications in the documents.

Within 2 working days upon receiving the expert opinion, Roszdravnadzor makes a decision regarding the possibility of introducing modifications to the documents listed in subparagraph a of paragraph 54 of the Rules and notifies the applicant of its decision by registered post or in electronic form by any means of telecommunication.

If the registration authority receives from the expert body an opinion regarding the impossibility of making changes to the medical product registration documents, it may refuse making such modifications.

The registration file is preserved by the registration authority in accordance with the procedure adopted by the Russian legislation on archiving.

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