Making Amendments to Registration Documents
Complete Cycle of Amending Documentation for Medicinal Products: Analysis, Unification, Submission, and Monitoring.
To make amendments to the documents contained in the registration dossier for a registered medicinal product intended for medical use:
1. The applicant (the holder or owner of the registration certificate for the medicinal product, or another legal entity authorized by them) submits an application via the unified portal to the authorized executive body or to the personal account of the authorized body.
2. The application must be signed with a qualified electronic signature and composed in the form established by the authorized body.
3. Documents that must be attached:
- Amendments to the specified documents.
- Documents supporting the necessity of the amendments.
- Documents confirming payment of the state fee.
4. Conducting the Evaluation:
- An evaluation of the proposed amendments is conducted regarding the quality of the medicinal product.
- An evaluation of the expected benefit versus the potential risk of the medicinal product for medical use.
5. Decision-Making on the Evaluation:
- The decision to conduct the evaluation is made in accordance with the approved classification of amendments made to the registration dossier documents.
6. Review Timelines:
- According to the Federal Law of the Russian Federation dated April 12, 2010, No. 61-FZ "On the Circulation of Medicines," the decision to approve or deny the amendments is made within:
- 90 working days for amendments requiring evaluation.
- 30 working days for amendments not requiring evaluation.
According to the Decision of the Council of the Eurasian Economic Commission dated November 3, 2016, No. 78, the review timelines are:
- For changes of type IA and IB — from 20 to 60 working days.
- For changes of type II — from 40 to 60 working days + 90 working days for a response to the inquiry.
Services and Stages:
- Analysis of submitted documents
- Unification of documents in accordance with registration rules as per Federal Law 61-FZ dated April 12, 2010, or the Decision of the EAEU Council No. 78 dated November 3, 2016
- Preparation of necessary documents, formation of a dossier, submission of the dossier to the Ministry of Health of the Russian Federation
- Monitoring the evaluation process (including pharmaceutical evaluation)
- Completion of the process for amending documentation, obtaining documents that were amended.
To make amendments to the documents contained in the registration dossier for a registered medicinal product intended for medical use:
1. The applicant (the holder or owner of the registration certificate for the medicinal product, or another legal entity authorized by them) submits an application via the unified portal to the authorized executive body or to the personal account of the authorized body.
2. The application must be signed with a qualified electronic signature and composed in the form established by the authorized body.
3. Documents that must be attached:
- Amendments to the specified documents.
- Documents supporting the necessity of the amendments.
- Documents confirming payment of the state fee.
4. Conducting the Evaluation:
- An evaluation of the proposed amendments is conducted regarding the quality of the medicinal product.
- An evaluation of the expected benefit versus the potential risk of the medicinal product for medical use.
5. Decision-Making on the Evaluation:
- The decision to conduct the evaluation is made in accordance with the approved classification of amendments made to the registration dossier documents.
6. Review Timelines:
- According to the Federal Law of the Russian Federation dated April 12, 2010, No. 61-FZ "On the Circulation of Medicines," the decision to approve or deny the amendments is made within:
- 90 working days for amendments requiring evaluation.
- 30 working days for amendments not requiring evaluation.
According to the Decision of the Council of the Eurasian Economic Commission dated November 3, 2016, No. 78, the review timelines are:
- For changes of type IA and IB — from 20 to 60 working days.
- For changes of type II — from 40 to 60 working days + 90 working days for a response to the inquiry.
Services and Stages:
- Analysis of submitted documents
- Unification of documents in accordance with registration rules as per Federal Law 61-FZ dated April 12, 2010, or the Decision of the EAEU Council No. 78 dated November 3, 2016
- Preparation of necessary documents, formation of a dossier, submission of the dossier to the Ministry of Health of the Russian Federation
- Monitoring the evaluation process (including pharmaceutical evaluation)
- Completion of the process for amending documentation, obtaining documents that were amended.
Moscow, 117105, Varshavskoye Highway, Building 1, Block 6.
© ООО «ФармРегС»
