Draft of the long-awaited amendments to the Registration Rules is finally published (extension of national Reg.Certificates for the period of harmonization and recognition, and an open-ended paragraph 30).
On April 15, 2025, the Union Legal Portal published Order of the EEC Collegium No. 46 of April 14, 2025 “On the Draft Decision of the Council of the Eurasian Economic Commission ‘On Amendments to the Decision of the Council of the Eurasian Economic Commission No. 78 of November 3, 2016’”
Key points of the draft:
Renewal is possible both in the reference state (for a maximum of 3 years from the date of filing the application in the reference state) and in the states of recognition (for a maximum of 2 years from the date of filing the documents in the state of recognition).
‼‼ IMPORTANT - the actual transition period (until 31.12.2025) does not change, as it is fixed in the Agreement on Common Principles.
Direct link to the text of the document: https://docs.eaeunion.org/upload/iblock/7c1/jbcbmsiccpl089qzphiur0a0pa5nodoy/Rasporyazhenie-Kollegii-_-46-ot-15-aprelya-2025-g.pdf
The above described is NOT a Council Decision but a draft, the Decision itself will be approved shortly and will enter into force within 30 days from the date of its publication.
On April 15, 2025, the Union Legal Portal published Order of the EEC Collegium No. 46 of April 14, 2025 “On the Draft Decision of the Council of the Eurasian Economic Commission ‘On Amendments to the Decision of the Council of the Eurasian Economic Commission No. 78 of November 3, 2016’”
Key points of the draft:
- Retention (in the form of extension of validity) of national registration certificates in the EAEU member countries after 31.12.2025, provided that an application is filed in the reference member country to bring the registration dossier into compliance with the mandatory indication of the countries of recognition.
Renewal is possible both in the reference state (for a maximum of 3 years from the date of filing the application in the reference state) and in the states of recognition (for a maximum of 2 years from the date of filing the documents in the state of recognition).
‼‼ IMPORTANT - the actual transition period (until 31.12.2025) does not change, as it is fixed in the Agreement on Common Principles.
- Clause 30 became open-ended, allowing instead of the EAEU GMP certificate to provide a package of supporting documents + the obligation to undergo inspection within 3 years after receiving the RI, while stricter requirements were established in clause 159 regarding the consequences of failure to fulfill this obligation.
- The format of the expert report and annexes to the expert report was significantly improved and expanded in accordance with the practice of authorized bodies and expert organizations.
- The possibility of amending the registration dossier in the reference State during the period of the recognition procedure in the recognizing States.
- Approaches to amendments relating exclusively to recognition states have been clarified.
Direct link to the text of the document: https://docs.eaeunion.org/upload/iblock/7c1/jbcbmsiccpl089qzphiur0a0pa5nodoy/Rasporyazhenie-Kollegii-_-46-ot-15-aprelya-2025-g.pdf
The above described is NOT a Council Decision but a draft, the Decision itself will be approved shortly and will enter into force within 30 days from the date of its publication.