Bringing Registration Dossiers into Compliance with EAEU Rules — How to Calculate Marketing Authorization Extension Deadlines After Decision No. 34
31 December 2025 was set to mark the mass expiration of national marketing authorizations (MAs) for medicinal products across the Eurasian Economic Union (EAEU) member states. By that date, thousands of medicinal products registered under individual member states’ national procedures, prior to the transition to unified Union rules, were required to complete dossier alignment with EAEU requirements or lose their lawful circulation status. The pharmaceutical industry was bracing for shortages across hospital and retail pharmacy networks.
That collapse was averted. Decision No. 34 of the Council of the Eurasian Economic Commission (EEC), dated 22 May 2025 (hereinafter, Decision No. 34), replaced the rigid hard-stop cutoff with an extension mechanism tied directly to the date an application is filed. For regulatory affairs managers, this introduces a new timeline arithmetic: a marketing authorization stays valid for exactly as long as calculated from the specific dossier submission date, a date unique to each authorization holder.
How Marketing Authorizations Expired Prior to Decision No. 34
The Rules for Registration and Examination of Medicines for Human Use, approved by EEC Council Decision No. 78 of 3 November 2016 (hereinafter, Decision No. 78), originally established a transitional period for medicinal products registered under member states’ national procedures. Subparagraph «в» of Paragraph 2 of Decision No. 78 permitted extensions of such national authorizations no later than 31 December 2025. Subparagraph «г» required authorization holders to bring their registration dossiers into alignment with Union requirements by the same date, using the procedure set out in Section XIII of the Rules.
Prior to the 2025 amendments, subparagraph «д» made no exception for applicants who had filed their application on time but had not yet completed the review. The authorization ceased to be valid on 31 December 2025, regardless of the procedure’s stage at the Reference State or in the States of Recognition. An applicant who filed a dossier in November 2025 faced the real risk of losing their authorization, even with a review proceeding without any deficiencies.
In addition, Paragraph 30 of the Registration Rules permitted applicants to submit an alternative document package in place of a valid Union GMP (Good Manufacturing Practice) certificate, but only until 31 December 2024. After that date, this alternative pathway was no longer available.
Rules for Marketing Authorization Extensions Under Decision No. 34
Decision No. 34 was officially published on 22 May 2025 and entered into force on 21 June 2025, thirty calendar days after publication. Certain provisions (subparagraphs «в», «г», «е», «п», «р» and «с» of Paragraph 2 of the amendments) apply retroactively to legal relations arising from 1 January 2024.
The timeline rule now splits into two cases. If an applicant filed an alignment application with the Reference State before 31 December 2025, and the procedure is still ongoing as of that date, the authorization is extended for the duration of the procedure, up to a maximum of 3 years from the filing date at the Reference State. An additional extension is granted for the duration of the procedure at each State of Recognition, up to a maximum of 2 years from the date the application reached it. The application to a State of Recognition must be filed before the 3-year period from the filing date at the Reference State expires.
If the procedure at the Reference State was already completed before 31 December 2025, authorizations at the States of Recognition are extended for the time needed to conclude the work there, up to a maximum of 2 years counting from 31 December 2025.
For applicants who did not file by 31 December 2025, no extension applies. Paragraph 164 of the Rules, as amended by Decision No. 34, covers medicinal products manufactured in third countries and imported into the Union. Without a filed application, they may continue to be marketed after 31 December 2025 under the national legislation of the member state that issued the authorization. Such medicinal products lose their Union-wide recognition and shift to a purely national circulation regime in that one country.
At the same time, an addition to Paragraph 165 of the Rules allows previously manufactured batches, whose authorization was extended under subparagraph «е» of Paragraph 2, to be sold until the end of their shelf life, even if the extension period itself has already expired.
Paragraph 164 does not apply to medicinal products manufactured within member states that never entered the alignment procedure — it covers only third-country imports. A more general rule applies to them instead: the base text of Paragraph 165 allows already-released batches to be sold until the end of their shelf life whenever any marketing authorization expires, regardless of where the product was manufactured. The difference from imported medicinal products is substantial: Paragraph 165 preserves the right to sell existing stock and does not restore Union-wide recognition, nor does it permit releasing new batches.
| Parameter | Prior to Decision No. 34 | Under Decision No. 34 |
|---|---|---|
| Application filed, procedure not completed at the Reference State | MA loses validity on 31.12.2025 without exception | Extended for the duration of the procedure, up to 3 years from the filing date at the Reference State |
| Procedure at a State of Recognition | No separate extension provided | Plus up to 2 years from the filing date at the State of Recognition, no later than the expiry of the 3-year period |
| Procedure completed at the Reference State before 31.12.2025 | No extension provided for the States of Recognition | Extension for the States of Recognition of up to 2 years from 31.12.2025 |
| Application not filed (imported medicinal product from third countries) | MA is annulled on 31.12.2025 | Marketing continues under the national law of the issuing state, without recognition in other Union member states |
| Paragraph 30 of the Rules, alternative to the GMP certificate | Applied until 31.12.2024 | No time limit |
Decision No. 34 also gave the authorized bodies of member states the right to reflect extension status in national medicinal product registers. Subparagraph «ж» of Paragraph 2 establishes a right without an obligation: it reads «may indicate.» In practice, an entry reflecting the extended validity period may not appear immediately or consistently across every register. It is best to verify an authorization’s status directly with the competent authority: registry entries can lag behind the actual decision.
A separate duty falls on the Reference State. Paragraph 170 of the Rules, as amended by Decision No. 34, requires the competent authority of the Reference State to notify the competent authorities of the States of Recognition within 5 business days about applications filed as of 31 December 2025, and to keep them informed of subsequent decisions as the procedure progresses. For an authorization holder, this is an extra channel for verification: if a State of Recognition has no record of your application, ask the Reference State whether the notification was sent.
How to Confirm GMP Compliance Without a Valid EAEU Certificate
If a manufacturing site has no valid document confirming compliance with the Union’s Good Manufacturing Practice requirements, Paragraph 30 of the Registration Rules allows submitting an alternative package of six elements instead:
a valid national GMP certificate issued by the competent authority of the manufacturing country;
a copy of the report on the results of the site’s most recent inspection over the past 3 years;
information on the results of all GMP inspections of the site over the same period;
data on quality complaints for products from this site over 3 years;
consent to undergo a pharmaceutical inspection for compliance with Union GMP;
a copy of the manufacturing site’s master file.
Until 31 December 2024, this option applied as a temporary measure. Decision No. 34 removed the date limit, and Paragraph 30 now applies with no expiration.
The Reference State decides for itself when to carry out the inspection. Under Paragraph 31 of the Rules, based on a risk assessment, it either orders an unscheduled inspection during the registration or alignment procedure itself, or adds the site to an inspection plan for the first 3 years after the procedure is completed. If a site is on that plan and fails to pass inspection once those 3 years have elapsed, Paragraph 159 of the Rules, as amended by Decision No. 34, names this directly as grounds for suspending or revoking the authorization.
Combining Alignment with Dossier Variations
Before Decision No. 34, an authorization holder generally had to wait for alignment to finish in every declared member state before making any changes to the dossier. Decision No. 34 reworked Paragraph 66 of the Rules and added Paragraph 2.5 to Annex No. 19: an applicant may now initiate a variation procedure at the Reference State before registration is completed at the States of Recognition.
The mechanism depends on the type of variation. For minor variations (type IA and IANU) approved by the Reference State during the recognition procedure, the applicant, once that procedure concludes, files a variation application with the competent authority of the State of Recognition together with a copy of the Reference State’s decision. For major variations (type IB and II), a similar scheme applies, with an added request for access to the assessment report. The Reference State must grant that access no later than 5 business days. The State of Recognition must decide on the variation no later than 20 business days from receiving the application and supporting documents.
For a regulatory affairs manager, this removes a common obstacle in migration: previously, any update to the package leaflet, a specification, or a manufacturing scheme had to wait until the procedure finished simultaneously in every Union country where the product was registered. Now variations can be filed in parallel with the recognition procedure, without waiting for the outcome in each individual state.
Action Plan
Determine the status of each authorization. Split the portfolio into three groups: application filed and the procedure is ongoing; application filed and the procedure is completed at the Reference State; application not filed by 31 December 2025.
Record the filing date at the Reference State. Both the 3-year extension period and the deadline for filing with the States of Recognition are counted from it. For example, an application filed on 15 December 2025 gives a 3-year window that ends on 15 December 2028 — by that date, the procedure at the Reference State needs to be complete and applications need to be filed with every State of Recognition.
Check the filing status at every State of Recognition. If an application has not yet been filed there, work out the time remaining before the 3-year period from the Reference State filing date expires, and file the documents well in advance to allow for preparation. Do not wait for the procedure to finish in every country at once if the package leaflet or a specification needs updating: Paragraph 2.5 of Annex No. 19 allows initiating variations at the Reference State in parallel with the recognition procedure.
Prepare the alternative GMP package under Paragraph 30 of the Rules if there is no valid EAEU certificate, and confirm the site is ready for an unscheduled inspection.
For non-migrated authorizations, decide on the next step. Paragraph 164 of the Rules covers medicinal products manufactured in third countries and imported into the Union: without a filed application, such a product is marketed under the national law of the issuing state and loses recognition in the rest of the Union. For medicinal products manufactured within a member state, Paragraph 165 applies instead: already-released batches can be sold until the end of their shelf life. Union-wide recognition is not restored. Either way, decide whether to start a full registration under Union rules from scratch or stay limited to the national market.
Decision No. 34 preserved the transition period and made it manageable. Companies that filed their documents before 31 December 2025 got a predictable timeline instead of a hard cutoff. That predictability requires precisely tracking the filing dates in every state. Those who missed the deadline face a choice between the national market of a single country and a full registration under Union rules from the ground up.
Regulatory Framework:
1. EEC Council Decision No. 78 of 3 November 2016, «On the Rules for Registration and Examination of Medicines for Human Use» (as amended on 26 November 2025)
2. EEC Council Decision No. 34 of 22 May 2025, «On Amendments to Decision No. 78 of the Council of the Eurasian Economic Commission of 3 November 2016»