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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