Amendment of registration dossiers

The rules governing the mandatory state registration of medical products are set forth by RF Governmental Resolution No. 1416 dated 27 December 2012. This regulation establishes that the procedure is to be performed on the basis of the applicant’s presentation of the corresponding registration dossier. The dossier is a set of documents confirming the product’s quality, safety and efficacy.

That said, the content of these documents must fully reflect the actual, and even more importantly – current characteristics of the product circulating on the market. Thus, in the event of a change in the product’s characteristics, or a change in the information about its manufacturer, the registration dossier must be updated with the respective amendments. The procedure for the making of such amendments is differentiated, depending on their significance.

Amendments not requiring the performance of follow-up expert evaluation

While the updating of details concerning the product’s manufacturer doesn’t usually require the performance of a follow-up expert evaluation of the product’s quality, safety and efficacy, these new details must nevertheless be reflected in the registration dossier. This is done in case of changes involving:

• details concerning the holder of a valid registration certificate, including the name of the company and/or its form of incorporation or, in the event that the holder is an individual entrepreneur – details concerning the holder’s last, first and middle names, passport details and place of residence;
• address of the location where the medical products are being manufactured;
• product name;
• product characteristics or functional properties not associated with its mode of operation or intended purpose, provided that such changes are aimed at the improvement and enhancement of its performance. For example, such changes can involve the addition or exclusion of supplemental accessories intended for the product’s use, an increase or decrease in the number of the product’s component parts, the updating of packaging and labeling, the creation of additional design variants, etc.
• details on the validity period of the documentation forming the registration dossier;
• information on the manufacturing company’s authorized representative.

Pursuant to Roszdravnadzor Order No. 3371 dated 6 May 2019, in such cases, the responsible agency must update the set of registration documentation for the product with the new information within a period of no more than 15 business days. Pursuant to Article 333.32.2 of the RF Tax Code, the state fee for this service amounts to RUB 1,500.

Amendments requiring the performance of follow-up expert evaluation

In case of changes involving the product’s key characteristics that have a significant impact on its therapeutic, diagnostic, prophylactic and/or other medical properties, a follow-up expert evaluation is scheduled in order to determine its current quality, safety and efficacy parameters. In this situation, the amount of the state fee for the completion of the respective actions is determined by the risk class of the product’s potential use. Pursuant to Clause 12(3) of Order No. 3371, in this case, the timeframe given to the department for making the respective updates to the registration dossier is increased to 35 business days.

At the Center for the Registration of Medical Products, you can order a comprehensive service for the handling of amendments to the registration dossier. Our experts will prepare the necessary documents using the standard forms, submit the application to the department and provide oversight to ensure that the service is provided in accordance with the applicable rules.