Post-2028 Transition of Russian Registration Portfolios to Union Rules

1. Key takeaways

Existing Russian national registration certificates do not lapse after 2028: the validity of the rules of Decision No. 1684 has been extended to 31 December 2028, and variation applications submitted before that deadline are still processed under the national rules; meanwhile, new applications from 1 January 2028 can only be filed under the Union rules. The result is a pattern of existing certificates remaining manageable while new volume switches tracks. A portfolio that mixes old and new products therefore runs two regulatory tracks simultaneously, each with its own obligations, timelines and documentation standards.

The practical consequence is that the year 2027 becomes the pivot year. Variations that a company knows it will need should be brought forward and submitted under the national rules before 31 December 2028, while evidence packages for any product that will need a Union application must be built to Union depth during 2027. Companies that treat 2028 as a distant deadline typically discover in the second half of 2027 that expert organisations, laboratories and authorised representatives are fully booked.

The ratification step also deserves monitoring rather than assumption. The Protocol was signed on 29 December 2025 and ratified by the Russian side through Federal Law No. 288-FZ of 4 August 2026, and the checklist of transition planning should record whether the Protocol applies provisionally or is already in force at the time of each decision, because the applicability status determines which timetable governs a specific application. Re-checking that status at each planning round is a five-minute task that prevents a systematically wrong schedule.

2. Legal basis

The transition architecture is defined by the extension of the national rules, the protocol amending the 2014 agreement and its ratification, and the Union rules that apply to new applications after 2028. The instruments are summarised below.

3. Expert insights

Insight 1: existing certificates and new volume must be managed in separate registers. The compliance actions for existing certificates — variations, monitoring, marking — can continue under the national rules until the end of 2028, while the path for new products switches to the Union rules from the beginning of 2028, since new applications from 1 January 2028 can only be submitted under the Union rules. The two registers carry different checklists, and merging them is the most common source of missed deadlines in a transition portfolio: an action planned on the national timetable but executed against a Union requirement, or the reverse.

Insight 2: switching tracks is in substance an upgrade of the dossier. The evidentiary depth demanded by the Union path is higher than that of the national path: the quality management system (in the direction of EEC Decision No. 106), biological evaluation (in the direction of Decision No. 38), and communication with reference countries and recognised countries all have to be prepared in advance. The gap analysis between the existing national dossier and the Union evidence package should be run early, because some evidence — particularly biological evaluation data — has long lead times that no amount of late scheduling can compress.

Insight 3: the Union path is not opening only in 2028. Choosing to move to the Union path early, within the window still available, avoids the concentrated queue at the end of 2027 and makes it easier to position in several member states at once. For portfolios with genuine multi-country ambitions, the Union route is not only a compliance necessity after 2028 but also an efficiency choice before it: one application, several markets, and a single evidence standard maintained thereafter.

4. Practical recommendations

The recommendations below separate the maintenance workload from the transition workload, which is the core of transition planning.

1. Establish dual registers for existing certificates and for new volume, and schedule preliminary studies of the Union path for every incremental product, so that the 2028 switch does not arrive as a surprise.
2. Execute the evidence preparation planned for 2027 at Union depth, so that one investment of effort serves both the national maintenance and the future Union application.
3. For products serving only the single Russian market with no successor models planned, maintain them under the national rules until 2028 — a Union application would be investment without a return.
4. Bring forward to 2027 the variations that are already foreseeable for 2028, and track the submission dates in the register rather than in individual memories.

5. Verification checklist

The checklist below confirms that the portfolio is split, scheduled and evidenced for the transition.

• □ The portfolio has been split into two registers: maintenance of existing certificates and transition of new volume
• □ Variations planned for 2028 have been brought forward to begin in 2027
• □ The evidence gaps for the Union path — QMS, biological evaluation and related items — have been assessed
• □ The reference country scheme for multi-member-state market plans has been determined
• □ The applicability status of the Protocol (provisional application / in force) has been re-checked
• □ The date 2028-12-31 as the close-out deadline for existing certificate variations is recorded in the register

Regulatory information verified as of 29 October 2026.

GRZAN advises manufacturers on the post-2028 transition of their Russian portfolios, including dual-track register design, gap analysis against Union evidence requirements, reference country selection and variation scheduling ahead of the 31 December 2028 close-out, together with post-market vigilance, recall and inspection support. For transition planning assistance, contact us at info@grzanglobal.com.