Procedure for bringing the registration dossier in line with the requirements of the EAEU
Bringing the registration dossier into line with the requirements of the EAEU every day becomes an increasingly urgent task. This is quite natural, because the registration dossier for each medicine must pass this procedure until 31.12.2025. According to the single register of registered medicines of the Eurasian Economic Union (https://portal.eaeunion.org/sites/commonprocesses/ru-ru/Pages/DrugRegistrationDetails.aspxhttps://portal.eaeunion.org/sites/commonprocesses/ru-ru/Pages/DrugRegistrationDetails.aspx) 68 registration certificates have passed this stage.
Compliance includes the provision of registration dossier documents for a registered drug in the format of a common technical document (CTD).
The composition of the CTD for this procedure includes:
- Application form;
- Documents confirming the payment of the fees for the conformance;
- Modules 1-3 of the registration dossier;
IMPORTANT: it is not possible to make changes to the documentation as part of the procedure of bringing in line the dossier with the EAEU requirements.
This is evidenced by paragraph 171 of the Rules: the applicant shall submit a written confirmation that the documents and data contained in the submitted updated registration file in the format of the common technical document, are identical in content to the registration file of the registered drug and do not contain changes to the registration file, which affect the quality, effectiveness, safety or benefit – risk ratio of a medicine.
Further, before bringing the dossier into line, it is necessary to determine where the drug is planned to circulate. This information will need to be specified in the application form and the format of providing information for the patient will depend on the choice of geography. In case the circulation is planned only in the territory of the Russian Federation, within the framework of compliance it will be necessary to provide the current Instructions on medical use. If it is planned to expand the geography, namely the circulation is planned on the territory of, for example, Russia, Belarus and Kazakhstan, then it is necessary to provide a Patient Leaflet and a Summary of Product Characteristics (SmPC). Read our section about the requirements for the patient leaflet and readability test.
In terms of the procedure itself, the applicant shall submit the above documents to the authorized body of the referent State.
Further, in the case of the Russian Federation, the Ministry of Health carries out an assessment of completeness, and correctness of the registration dossier within 14 working days before sending it for expertise.
At this stage, MoH can request more information. The applicant is given 90 calendar days to eliminate the request.
Further, the examination of quality, efficiency and safety is carried out — 50 working days. There is also additional information can be requested (to eliminate 90 calendar days).
Notice of the decision — 14 working days.
Following the results of compliance with the requirements of the Union, the applicant has the right to initiate the procedure of recognition of the expert report on evaluation in the member states of the Union, in which the drug was registered earlier under national procedures.
Learn more about the alignment procedure: email@example.com
- Council of the EURASIAN ECONOMIC COMMISSION N 78 ON THE RULES OF REGISTRATION AND EXAMINATION OF MEDICINES FOR MEDICAL USE;
- Materials of the Scientific and Practical Conference “Expertise and Registration of Medicines in the EAEU” REGLEC — EAEU 2020.