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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3. The Procedure and Timeline of EAEU Dossier Harmonization

As per the Rules, EAEU dossier harmonization procedure is to be completed within 70 business days from the day of submission of the application.
That is ideal scenario without taking into account clock stops and possible extension of the timeline due to dossier changes that can be added to the basic procedure.
We at Pharegis are always staying tuned, providing you the actual procedure with the latest approved changes as of November 2023. The procedure consists of several stages described below. 

3.1. Completeness and Accuracy Check - 10 Business Days

Within 10 business days from the submission date the authorized body (expert organization) of the reference state verifies the completeness and accuracy of the format of the documents submitted in the registration dossier before the assessment of the registration dossier is started.

Potential “Clock Stop” 1 (maximum term – 90 Business Days)

In case of any observations of the authorized body (expert organization), it issues official request to the applicant in electronic form and shall be considered received after 1 calendar day from the date of its sending.
The maximum time for the response submission is 90 business days, that “clock stop” time provided for the response is not counted in the official procedure timeline.

Evaluation of the Applicant's Response (5 Business Days)

Evaluation of the response is performed in 5 business days from the date of the receipt of the response.

3.2. Expert Examination of the Dossier – 45 Business Days

After the initial phase of assessment of completeness and accuracy of the format of the documents, expert examination of the submitted dossier is performed within 45 business days starting from:
- either the date of finished completeness and accuracy check of the registration dossier,
- or the date of receipt of corresponding official assignment from MoH for the examination by the expert organization

Potential “Clock Stop” 2 and Further “Clock Stops” (maximum cumulative term is 180 Business Days)

In frames of the expert examination the authorized body (expert organization), can issue specific request to the contents of the dossier.
The maximum term for the response submission is limited by 90 business days, that “clock stop 2” term provided for the response is not counted in the official procedure timeline. There can be additional request(s) that can be only related to the contents of the initial expert examination request and any flaws/incompleteness of the corresponding response.
Total timeline granted to the applicant for all such responses is limited by 180 business days.
The expert examination stage ends by the issuance of the expert examination report by the authorized body (expert organization).

3.3. Issuance of the EAEU Registration Certificate - 10 Business Days

In case of positive decision on compliance of the registration dossier with the EAEU requirements, the authorized bodies of the member states where the medicinal product is registered and where the application was submitted, issue the registration certificate of the medicinal product within 10 business days from the date of receipt of the expert assessment report.
Along with the registration certificate, approved essential parts of the dossier, namely: the normative document (ND), SmPC, PIL, packaging artworks for the drug product, as well as (where applicable) SmPC, PIL and packaging artworks in member states languages, and (if needed) - approved risk management plan.

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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.

© Pharegis LLC, 2023