Confirmation of State Registration of a Medicinal Product
Regulations for Issuing the Marketing Authorization for Medicinal Products in the Reference State and in the Member States of the Union:
The validity period of the registration certificate for a medicinal product registered for the first time in the reference state is 5 years. Upon expiration of this period, a perpetual registration certificate is issued, provided that the registration (re-registration) is confirmed. In cases related to pharmacovigilance, the authorized body may reissue the registration certificate for a 5-year term upon confirmation of registration (re-registration).
For a medicinal product registered under the legislation of a member state for 5 years or more, a perpetual registration certificate is granted if the product is intended for circulation only in that member state's market.
A registration certificate for a medicinal product registered under the legislation of member states, as specified in the application for compliance with Union requirements, which has been on the market of the reference state for 5 years or more, is issued for an unlimited period as part of the alignment process with Union requirements.
Services and Stages:
- Analysis of submitted documents
- Unification of documents in accordance with registration rules as per the EAEU Council Decision No. 78 dated November 3, 2016
- Preparation of necessary documents, formation of a dossier (both paper and electronic), submission of the dossier to the Ministry of Health of the Russian Federation
- Monitoring the expert evaluation and registration process (documentary and pharmaceutical expertise), providing consultations, and responding to inquiries from experts of the Ministry of Health of the Russian Federation and FGBU NC ESMHP
- Completion of the registration process, inclusion in the Register of Medicines, and obtaining the Registration Certificate
The validity period of the registration certificate for a medicinal product registered for the first time in the reference state is 5 years. Upon expiration of this period, a perpetual registration certificate is issued, provided that the registration (re-registration) is confirmed. In cases related to pharmacovigilance, the authorized body may reissue the registration certificate for a 5-year term upon confirmation of registration (re-registration).
For a medicinal product registered under the legislation of a member state for 5 years or more, a perpetual registration certificate is granted if the product is intended for circulation only in that member state's market.
A registration certificate for a medicinal product registered under the legislation of member states, as specified in the application for compliance with Union requirements, which has been on the market of the reference state for 5 years or more, is issued for an unlimited period as part of the alignment process with Union requirements.
Services and Stages:
- Analysis of submitted documents
- Unification of documents in accordance with registration rules as per the EAEU Council Decision No. 78 dated November 3, 2016
- Preparation of necessary documents, formation of a dossier (both paper and electronic), submission of the dossier to the Ministry of Health of the Russian Federation
- Monitoring the expert evaluation and registration process (documentary and pharmaceutical expertise), providing consultations, and responding to inquiries from experts of the Ministry of Health of the Russian Federation and FGBU NC ESMHP
- Completion of the registration process, inclusion in the Register of Medicines, and obtaining the Registration Certificate
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