1.What happens to registration certificates obtained by national procedure?
EEU Council Decision No. 46 implying discontinuance of registration certificates obtained under the national procedure on December 31, 2021, continues to be in effect as of today. However, the participants of European Economic Union agreed that these documents would be amended, namely:
- Registration certificates obtained by the national procedure of the member states after December 31, 2021 will continue to be in effect until expiration, namely:
- Russian Federation: termless
- Republic of Belarus: 5 years
- Republic of Kazakhstan: 5 years
- Kyrgyz Republic: termless
- Procedure of amending documents contained in registration dossier of medical products registered by the national procedure will remain possible and will occur according to the current legislation of the member states.
- The registration of medical products by national procedure of the EEU member states after December 31, 2021 will become impossible.
2. If we submit the registration dossier at the beginning of 2021, the registration procedure does not complete until December 31, 2021, then what kind of registration certificates will be issued to us?
In case the dossier is at the first stage of registration expertise (verification of completeness and authenticity of documents) on the stated date, it will be returned to the applicant as a result of discontinuance of the national procedure.
If the dossier is handed over to expertise organization, a refusal will be received as a result of discontinuance of the national procedure.
3. Is it possible to extend the effect of registration certificate only for one EEU country in case of registration under the standards of EEU?
No, it is not possible. There must be a reference country and at least one member state concerned.
The review of current regulatory legal acts is possible.
The only situation in which the registration certificate obtained by EEU procedure will be effective in only one state is that the expert organization of reference state issues affirmative conclusion and the expert organization of member state concerned (expert organizations of the member states concerned) does not agree with that conclusion. In this situation, the registration certificate will be effective only in the reference state.
4. How is the state fee for conformance of the expert conclusion by the reference state and member state concerned shall be paid? What is the amount?
After receiving a positive conclusion from authorized body of reference state, the applicant should pay state fees within 20 working days. For this, the applicant should enter into agreement with expert organizations of appropriate states. The amount of state fee is determined by the appropriate state expert organization in accordance with current price lists (depending on risk class of medical product, sterility / non-sterility, numbers of options for executions and other factors).
If the member state concerned is the Russian Federation, you should not enter into the agreement with an expert organization. Bill for state fee is simply being downloaded from the web-site of Federal Service for Supervision of Healthcare, filled and paid. The amount of state fee for conformance is determined by the Tax Code of the Russian Federation.