Bringing drug registration dossiers into compliance (harmonization) with Eurasian Economic Union (EAEU) requirements

1. Procedure for Bringing the Registration Dossier into Compliance with EAEU Requirements - Key Features and Challenges

Applicability: All National Drug Product Registrations in EAEU countries. Deadline

All registration dossiers for medicinal products registered as per national procedures in any EAEU member states (Russia, Belarus, Kazakhstan, Kyrgyzstan, and Armenia) should be brought into compliance with the EAEU requirements until the end of 2025. The deadline for the registration dossier EAEU harmonization procedure applies to all currently registered drug products in Russia and other EAEU countries.

This procedure is also called harmonization of the registration dossier with EAEU Rules or simply the EAEU dossier conversion procedure. 

Potential Positive Outcomes of the Procedure

 1. A termless EAEU registration certificate is issued by all applied member states in cases of > 5 years of national registration in the reference state, with no addition of EAEU member states (geographic extension) in the frames of the application.

2. EAEU registration certificate with a 5-year validity term is issued in cases of < 5 years have passed since the national registration in the reference state, or in cases where additional requirements and limitations are issued by the reference state in frames of the procedure.

Total Timeline

As per current EAEU regulations, the total duration of procedure can range from 70 business days (no any “clock stops”) to 250+ business days (case of two “clock stops” with the maximum allowed duration).

In cases where significant changes are required to be implemented and submitted within framework of the procedure, the total duration of the procedure will be extended further to the extent of the duration of the expert examination required for those changes.

Pharegis team prepares the dossier for bringing it into compliance with EAEU rules and requirements after having thorough gap analysis and discussing all steps, translations and modifications with each customer individually. Our sophisticated approach minimizes occurencies of the authorities' requests and corresponding "clock stops", resulting in maximum acceleration of the process overall.

Registration Dossier Requirements and Features of the Procedure

1. Any registration dossier that prepared for procedure of bringing into compliance with EAEU requirements should be submitted in EAEU Common Technical Document (CTD) format.

2. Written confirmation from an applicant that all the documents and contents of the EAEU-compliant registration dossier correspond in their contents to the relevant parts of the national registration dossier of the registered drug product and there are no any changes which impact the quality, efficacy, safety or risk-benefit ratio of that product.

3. It is possible to include non-significant variations to the registration dossier in frames of the procedure, any of such variations are to be prepared and processed as per the EAEU Rules. The reference state has the right to consider such changes within the timeframe of the EAEU dossier harmonization procedure.

4. Also it is possible to include significant changes (type II), duly justified as “required for the submission” (e.g. due to obsolete parts of national registration dossier) in frames of the procedure – in that case total duration of the procedure will be prolonged by the expert examination required for such changes.

5. Risk management plan section is required for all products except: products that are marketed > 10 years containing API with established efficacy and safety profile; homeopathic and herbal drug products

6. Consumer testing of Patient leaflet is not required as part of the dossier in frames of the procedure, but it can be requested by the member states where the product was not registered earlier.

2. Key Regulatory Documents for the Procedure

1. Decision of the Council of the Eurasian Economic Commission №78 dated 03.11.2016 (particularly - section XIII) – the core regulatory document for the procedure.
As of November 2023 there are several decisions of EEC that modify it, namely:
2. Decision of the Council of the Eurasian Economic Commission № 9 dated 30.01.2020 – currently specifies all types of changes that can be submitted together with the procedure.
3. Decision of the Council of the Eurasian Economic Commission № 34 dated 23.04.2021
4. Decision of the Council of the Eurasian Economic Commission № 36 dated 17.03.2022 –contains major update of the core Decision №78;
5. Decision of the Council of the Eurasian Economic Commission № 60 dated 22.05.2023;
6. Decision of the Council of the Eurasian Economic Commission № 114 dated 20.10.2023.
The latest Decision in 2023 dated 20.10.2023 has amended the core regulation with many significant changes.

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