How the 90-Calendar-Day Time Limit Counts in Belarus

1. Key takeaways

90 calendar days is the overall time limit; 150 calendar days is the cap after agreement of the parties — the two are not the same concept. Under Resolution No. 211 and the government press service announcement, the total duration of preliminary technical works before national registration may not exceed 90 calendar days. The period may be extended, but only with the consent of both sides, and in no case beyond 150 calendar days. Three consequences follow for planning. First, the clock that matters for downstream commitments — certificate hand-over to distributors, tender deadlines, launch dates — is the 90-day baseline, not the extension. Second, an extension is not unilateral: the organising body cannot simply add time on its own initiative, and the applicant’s agreement is a procedural condition. Third, because the limit covers the works as a whole, every work item inside the phase competes for the same budget of days, so the way the 90-day clock is modelled — calendar days versus working days — determines whether the entire project plan is realistic from the outset.

2. Legal basis

3. Expert insights

Insight 1: Calendar days, not working days. The announcement uses the term in the Russian original, календарных дней — calendar days. The difference in scheduling terms is substantial: 90 calendar days is roughly 3 calendar months, whereas 90 working days approaches 4.5 months. A company that builds its project model on working days will systematically overestimate the time available, and the overestimate propagates outward — to customer commitments on certificate dates, to distributor onboarding plans and to tender windows that assume the product will be registered by a given month. The error is not corrected later in the process, because no step ever announces that the clock is calendar-based; it simply runs. Correcting the model at the kick-off stage costs nothing. Correcting it after commitments have been made to customers or channel partners costs credibility and, in the worst case, a lost tender slot. The modelling choice should therefore be treated as a compliance decision, not an administrative detail.

Insight 2: Extension happens by agreement of the parties — it is not the organising body’s unilateral right. The announcement’s wording is explicit: extension occurs by agreement of the parties. This gives the applicant a dual position. On one hand, the applicant can decline an unjustified extension request, and the refusal has procedural weight because consent is a required condition; an organising body cannot simply restart the clock on its own motion. On the other hand, where additional time is genuinely needed for reasons attributable to the applicant — late samples, slow responses to technical queries, incomplete equivalence documentation — the applicant must proactively raise the extension and obtain agreement, rather than letting the deadline lapse silently. How extensions are initiated and documented should be agreed with the local representative at the project kick-off meeting, so that both sides know who proposes, who consents and in what written form.

Insight 3: The consequence of overrun is not automatic approval but loss of rhythm control. What Resolution No. 211 establishes is a time-limit constraint on the organising body; exceeding it does not produce a deemed-approval legal effect of any kind. The practical consequence of overrun is uncontrolled project rhythm — milestones slip relative to downstream contracts, and the slippage cascades into distributor agreements, tender deadlines and launch sequencing. This is why the productive question is not what remedies exist after overrun, but how to avoid triggering an extension at all: front-loading sample logistics, locking laboratory slots early and answering technical queries within agreed internal turnaround times. Remedies after overrun are, in any event, thin; prevention through scheduling discipline is the only lever that actually protects the commercial calendar.

Insight 4: Whether applicant response time counts must be fixed contractually. When technical queries arise during the works, whether the time the applicant spends preparing its answers counts toward the 90 days is the single most dispute-prone point in practice. GRZAN recommends writing the chosen treatment explicitly into the service contract or project plan — either applicant response time is excluded from the overall limit, or it is included — together with the mechanism for proving when a query was received and when the answer was dispatched. Without this, a late registration invites mutual recrimination: the organising body points to applicant delay, the applicant points to procedural slowness, and neither position is provable. A one-clause fix at contracting removes the entire category of dispute.

4. Practical recommendations

1. Model the schedule in calendar days, not working days. Convert the 90-day limit into approximately 3 calendar months when entering it into the master plan, and convert all downstream dependencies the same way so the whole chain stays consistent.
2. Put the response-time treatment into the contract. State explicitly whether the applicant’s time for answering queries counts toward the overall limit, and define the evidence — timestamps of queries and responses — used to measure it.
3. Set an internal early-warning line. Conduct a mid-phase review when the 90-day progress passes its midpoint, judge whether an extension is likely to be triggered, and prepare a negotiation position in advance rather than improvising one.
4. Keep written records of extension negotiations. Where an extension toward 150 days is discussed, retain the written correspondence; it serves both as the basis for schedule explanations to stakeholders and as the demarcation of responsibility between the parties.

5. Verification checklist

• □ Schedule modelled in calendar days (90 days ≈ 3 calendar months)
• □ Contract states whether applicant response time counts toward the overall limit
• □ Mid-phase review point set at the halfway mark of the 90 days
• □ Written record mechanism established for extension negotiations
• □ Aware that the extension cap is 150 calendar days and requires agreement of the parties

Regulatory information verified as of 2026-10-30.

On the Eurasian Economic Union market, GRZAN’s core capabilities concentrate on three points. First, distinguishing the applicable conditions and remaining time windows of the two pathways — Union-wide registration versus national registration in each member state: the national registration procedure for medical devices in Belarus has been switched wholesale by Council of Ministers Resolution No. 211 of 2026-04-28 (state register No. 6-1/55925, effective 2026-05-01), which compressed the total time limit for preliminary technical works to 90 calendar days, closed the list of such works and prohibited the organising body from expanding it, while the window for filing applications under the national procedure treats 2027-12-31 as the critical cut-off — pathway selection must therefore be decided in step with the time window. Second, authorised representative services: GRZAN can act as the manufacturer’s statutory representative in Belarus, undertaking registration filings, responses to technical queries, registration dossier amendments and post-market reporting obligations, and has synchronised its coordination mechanisms after Council of Ministers Resolution No. 378 of 2026-07-27 (effective 2026-07-30) transferred adverse-event functions to the state organisation for pharmaceutical supervision. Third, quality system and testing support: assistance in establishing a quality management system conforming to ISO 13485, and in organising technical documentation according to the target pathway — the national pathway follows the annex to Ministry of Health Resolution No. 55, while the Union pathway follows EEC Council Decision No. 46.

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