4. Requirements to the Application Dossier and its Documents for the Submission for EAEU Dossier Harmonization Procedure

Obligatory parts of the dossier for EAEU Dossier Harmonization procedure

An applicant shall submit the following documents and dossier parts to the authorized body (expert organization) of the reference state where the drug product is registered:

1. The application (hardcopy or electronic document signed with an electronic signature);

2. Documents confirming payment of the state duty for bringing into compliance with the EAEU requirements (hardcopy or electronic document);

3. Modules 1-3 of the registration dossier of the medicinal product on electronic media and (or) in the form of electronic documents.

Key features of the dossier for EAEU Dossier Harmonization Procedure.

Lots of significant changes were made since the establishment of the procedure in 2016, the most important modifications we implemented by the Decisions № 9 dated 30.01.2020, № 36 dated 17.03.2022 and № 114 dated 20.10.2023. We have summarized actual features of the EAEU Dossier Harmonization

procedure below.

1. It is allowed to present Module 2 of the dossier in the form of overview sections with the necessary updating of changes (as annexes) in the relevant sections 2.3 to 2.5 of module 2 of the registration dossier.

2. If there are differences in dosages or manufacturing sites in the registration dossier approved in different member states, the applicant shall provide updated information on the differences and their justifications in the form of the document "For the information of experts" within Module 1 of the registration dossier.

3. In the case of different manufacturing sites, comparative studies should be submitted to the authorized body (expert organization) of concerned member state(s).

4. If there are differences in indications for use, dosages and routes of administration of the medicinal product in different member states, the applicant shall submit updated information on the differences and their justification in sections 2.4 and 2.5 of Module 2 of the registration dossier, as well as the reports of relevant studies in Modules 4 and (or) 5 of the dossier.

5. Data of preclinical and clinical studies conducted in accordance with the requirements of the national legislation of the member states should be presented in modules 4 and 5 of the registration dossier in the form of corresponding reports. There is no need for bringing those reports of preclinical and clinical studies into compliance with the rules of execution of such reports established in EAEU.

6. In case of absence of necessary data in modules 4 and 5 of the registration dossier or in case of presence of new relevant safety information of the medicinal product, the authorized body (expert organization) of the reference state during the expert examination may establish additional obligations of the holder of the registration certificate, including limited duration of the registration certificate.

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