Armenia EAEU Accession and Transition Period 2026: Milestones Toward December 31, 2027

1. Key takeaways

Armenia signed the Protocol on its Accession to the Agreement of December 23, 2014 on December 2, 2015, and that date is the time anchor at which the entire batch of Union implementing decisions became effective for Armenia. The transition period itself has passed through three formulations: the original version of Decision No. 46 set it at 2021-12-31; the protocol signed on December 30, 2021 changed the reading to devices registered under national rules remaining in circulation until their registration documents expire, with amendment applications possible until 2026-12-31; and Armenian national law now sets the transition period at 2027-12-31. The GRZAN conclusion: for judgments made inside Armenia, the governing date is December 31, 2027, while Union-level expiry dates of legacy registrations must still be checked product by product. Planning against the wrong layer of rules is itself a compliance risk, because the Union and national dates serve different questions: one governs legacy registration validity, the other governs parallel circulation of unregistered devices.

2. Legal basis

3. Expert insights

Insight 1: the 2015-12-02 Protocol is an entry-into-force trigger, not a transition-period document. GRZAN has verified the entry-into-force clauses of Council Decisions No. 26, 27, 28 and 42: each states that it takes effect 10 calendar days after the entry into force of the Protocol on the Accession of Armenia of December 2, 2015, and in no case earlier than 10 calendar days after official publication. This shows that although Armenia was a late acceding party, the entire body of implementing rules was triggered for it in a single consolidated event, with no item-by-item negotiation of separate effective dates. Project planning can therefore treat one date as the starting line for the whole rulebook.

Insight 2: the original transition period (2021-12-31) has been superseded by two layers of documents. Article 2 of Decision No. 46 once provided, in item a, that during the transition period (to 2021-12-31) registration could be carried out at the choice of the manufacturer (or its authorized representative) either under the Union rules or under the legislation of the member states; item b provided that registration documents issued under the legislation of the member states remained valid until their expiry, but no later than 2021-12-31. After the 2021 replacement by Decision No. 144, both items were carried by the Agreement protocols and by national law, and companies should no longer plan against the end of 2021.

Insight 3: the 2021-12-30 Protocol established a dual track of legacy circulation plus legacy amendments. Under that protocol: medical devices previously registered under the national rules of a member state may be placed on the market and circulated in its territory until the documents evidencing their registration expire; amendments to the registration documents of such devices are allowed where applications are submitted before 2026-12-31; and from 2022-01-01, new medical devices are registered only under the Union rules. GRZAN notes: the rule that new devices can only follow the Union route has never been relaxed; what has changed is only the treatment of legacy devices already on the market.

Insight 4: Armenian national law fixes the cut-off at 2027-12-31. The official page of the Ministry of Health of Armenia states clearly that under the transition period established by the Law On Medical Assistance and Services to the Population, until December 31, 2027, unregistered medical devices may circulate in the Republic of Armenia in parallel with registered medical devices. GRZAN notes that this is a national-law arrangement that operates in parallel with the Union-level rule on expiry of legacy registrations, and that compliance planning in Armenia should follow whichever of the applicable dates expires first for the product concerned.

4. Practical recommendations

1. Treat 2027-12-31 as the master milestone for Armenian projects, while checking for each product the two earlier dates: the expiry date of the legacy registration certificate and the 2026-12-31 cut-off for amendment applications.
2. Do not expect the transition period to cover new devices: from 2022-01-01 new devices are registered only under the Union rules, and the transition period can only address legacy and unregistered devices at import.
3. File legacy amendments early, not late: holders of certificates issued under national rules who intend to amend them should submit applications before 2026-12-31.
4. Monitor regional developments: Belarus approved two draft protocols by Presidential Decree No. 441 on December 17, 2025, including an extension of the transition period to 2027-12-31; GRZAN will continue tracking ratification progress in each member state (practical estimate: the status of domestic procedures for the protocol in each member state follows official publication).

5. Verification checklist

1. □ The triggering role of the 2015-12-02 accession Protocol in the regulatory chain of this product has been confirmed.
2. □ It has been confirmed that the project applies 2027-12-31 under Armenian national law rather than 2021-12-31.
3. □ The expiry dates of legacy registration certificates have been checked product by product.
4. □ It has been confirmed whether any planned legacy amendment will be submitted before 2026-12-31.
5. □ It has been confirmed that new products are subject only to the Union registration rules from 2022-01-01.
6. □ A tracking mechanism for regional protocol ratification progress has been established.
7. □ The three dates have been marked in the product compliance calendar with an alert set 12 months in advance.

Regulatory information verified as of October 30, 2026.

GRZAN services. GRZAN International builds transition-period roadmaps and milestone calendars for manufacturers operating across the EAEU and Armenia. For inquiries, contact info@grzanglobal.com.