After 2028: What the EAEU Takeover Means for Registration in Belarus

1. Key takeaways

National registration is a channel with an end point. On the currently verifiable account, the transition period has been extended to 31 December 2027, with the possibility retained of accepting expert evaluation and registration applications under member-state legislative procedures until 31 December 2028; once the window closes, new registrations can in principle follow only the Union rules. The direction of travel is therefore fixed even though some of the dates still carry differing accounts in public statements. For manufacturers, the strategic meaning is simple: the national path is a transitional instrument with a calculable remaining lifetime, not a permanent alternative to the Union system. Every planning decision — dossier preparation, clinical evaluation strategy, budgeting for renewals — should be taken with the window closure in view, because work not completed inside the window will have to be redone under a different and structurally different procedure after it closes.

2. Legal basis

3. Expert insights

Insight 1: the original timetable has been postponed by two years, but the direction has not changed. The Agreement was originally designed so that registration would shift entirely to the Union rules from 2026-01-01. The protocol pushed the date back, but the direction — the final shift to the Union rules — has never changed. Manufacturers should therefore understand the national path as a transitional tool, not as a long-term option. Investment in the national path makes sense only inside the window; investment that pretends the window does not exist will end up stranded, and the sooner a company internalizes this, the less rework its regulatory plan will need.

Insight 2: three time dimensions must be understood separately. The transition period (2027-12-31) governs the institutional switch. The acceptance retention period (2028-12-31) governs whether applications can still be filed under member-state procedures. The continuation of circulation (until 2027-12-31, conditional on the registration documents remaining valid) governs how long already registered products may be sold. The three dates do not coincide, and mixing them leads to systematic misjudgment — for example, assuming that a product registered under the national path remains sellable as long as applications are still being accepted, when in fact circulation continuation ends a year earlier and is subject to a validity condition.

Insight 3: the structure of the Union path differs from the national path. Union registration uses a two-stage structure of reference-country assessment plus recognizing-country confirmation (following Council Decision No. 46), which is different from the Belarusian national structure of preliminary technical work plus a decision by the Ministry of Health. Before switching, manufacturers should redesign their project flow rather than reuse the scheduling model of the national path: the two stages involve different countries, different reviewers and different expectations about dossier format, and a schedule built on the national template will mislead management about both cost and duration.

Insight 4: preparing the Union path early yields high marginal returns. Since the switch itself is certain and only the timing still carries differing accounts, advancing the preparation of Union-path materials during the window allows a company to avoid starting from zero after the window closes. The preparation work — dossier mapping against Union expectations, identification of a reference country, alignment of quality system evidence — is largely transferable and loses nothing from being done early, which makes it one of the rare regulatory investments with a strictly positive option value.

4. Practical recommendations

1. Move Union-path preparation forward into the window period. Do not wait for the window to close before starting; begin the mapping and reference-country work while the national path is still available.
2. Redo the schedule on the two-stage model. Estimate the reference-country assessment and the recognizing-country confirmation separately, and present them to management as distinct phases with distinct risks.
3. Manage the validity of registration documents as the premise of continued circulation. Certificates that expire, are suspended or are cancelled fall outside the circulation continuation, so track validity dates as market-access deadlines.
4. Track the formal publication of the protocol. For the current differences between the 2027 and 2028 accounts, defer to the official text of the protocol and the interpretation of the competent authorities as they become available.

5. Verification checklist

• □ Preparation of Union-path materials has started within the window period
• □ The schedule has been redone on the two-stage model of reference country and recognizing country
• □ The validity of registration documents is managed as the premise of continued circulation
• □ The official text of the protocol and the interpretations of the competent authorities are being tracked
• □ The dates of 2027 and 2028 have not been merged into a single statement

Regulatory information verified as of 30 October 2026.

In the Eurasian Economic Union market, GRZAN concentrates its core capabilities on three fronts. First, distinguishing the applicable conditions and the remaining time windows of the two channels — Union-level unified registration and national registration in each member state. The national registration procedure of Belarus has been fully restructured by Council of Ministers Resolution No. 211 of 28 April 2026 (state registration number 6-1/55925, in force 1 May 2026): the total time limit for preliminary technical work is compressed to 90 calendar days, the scope list is closed and implementing organizations are prohibited from expanding it, while the window for filing applications under the national procedure takes 31 December 2027 as the key milestone, so path selection must be decided in step with the time window. Second, local authorized representative services: GRZAN acts as the statutory representative of the manufacturer in Belarus, handling registration filings, responses to technical queries, changes to the registration dossier and post-market reporting obligations, and it has already synchronized its liaison mechanisms after Council of Ministers Resolution No. 378 of 27 July 2026 (in force 30 July 2026) transferred adverse event functions to the State Institution for State Pharmaceutical Supervision (Gosfarmnadzor). Third, quality system and testing support: GRZAN helps establish a quality management system conforming to ISO 13485 and organizes technical documentation according to the target path — the national path follows the annex to Ministry of Health Resolution No. 55, while the Union path follows Eurasian Economic Commission Council Decision No. 46. For post-market compliance in the Belarusian market — vigilance, recalls and responses to supervisory inspections — GRZAN provides end-to-end support built on the same framework.

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