Amendment of registration certificates

According to applicable Russian legislation, any medical product being sold at pharmacies or other organizations must be accompanied by a valid registration certificate. This requirement is established by the provisions of Article 38 of RF Federal Law No. 323-FZ dated 21 November 2011, which deals with issues of public health and welfare. That said, the information contained in the RC must comport with the current characteristics of both the product itself as well as those of its manufacturer. This means that if they have changed since the moment of its issuance, the document must be updated.

Grounds for the updating of registration certificates

The issuance to the applicant of a registration certificate is undertaken by the responsible state agency, in this case – Roszdravnadzor. The department makes its decision based on its review of the registration dossier, reflecting the corresponding documented conclusions stemming from tests of the product’s quality, safety and efficacy. Thereafter, the product dossier continues to be stored for the entire duration of the certificate’s validity period and must always comport with the most up-to-date information on the product.

Thus, in the event of a change in the product’s parameters or the manufacturer’s details, this information must also be reflected in the registration certificate. Pursuant to Roszdravnadzor Order No. 3371 dated 6 May 2019, there are two distinct grounds for reviewing the contents of the registration dossier – those requiring and not requiring the performance of a follow-up expert evaluation of the medical product’s characteristics. A follow-up expert evaluation is conducted in cases involving a change in the product’s key parameters impacting its prophylactic, diagnostic, therapeutic and/or other critical medical properties. Pursuant to Clause 12(3) of Order No. 3371, in this situation, the responsible department is given no more than 35 business days to make the required amendments. The cost of the follow-up expert evaluation depends on the potential-risk class of the product’s use.

In all other cases, the performance of a follow-up expert evaluation is not required. In particular, such situations involve changes to:

• information about the name, form of incorporation and/or business address of the applicant or the individual/legal entity in whose name the registration certificate has been issued. If the concerned party is an individual entrepreneur, the dossier must reflect any changes to their last, first and middle names, passport details and/or place of residence;
• the product’s manufacturing address;
• validity periods of the documents forming the registration dossier;
• information on the manufacturing company’s authorized representative.

Pursuant to Clause 12(2) of Order No. 3371, the making of such amendments to the registration dossier should take Roszdravnadzor 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.

Procedure for replacing a RC

Any change in the data that must be reflected in the dossier and that entail the replacement of the registration certificate must be properly documented. Pursuant to Clause 38 of Resolution No. 1416, the applicant must prepare the required documents and submit them to Roszdravnadzor, together with the corresponding application for reissuance of the RC, within 30 business days of the onset of the respective circumstances. If the document is being replaced on grounds that do not entail the performance of a follow-up expert evaluation, that is – if the product’s fundamental medical properties have not changed, the manufacturer must enclose the respective conclusion by an expert organization or other documentation serving as confirmation of that fact. The absence of such documentation could serve as grounds for a denial of the RC’s reissuance. Other grounds for such a denial could be the inaccuracy of the information provided by the applicant. The application must also be enclosed with the original of the previously-issued registration certificate slated for replacement.

Having reviewed the submitted documents, Roszdravnadzor makes a decision on the application and notifies the addressee to that effect in regular paper or electronic form. Together with the notice, in the event of a positive decision, the applicant receives another two documents: the reissued registration certificate and the old RC, stamped invalid. For the swift organization of certificate replacement, you can contact the Center for the Registration of Medical Products. Our specialists will collect all of the required documents, send the application to Roszdravnadzor and oversee compliance with the requirements governing the provision of this state service.