Power of Attorney and Authorisation Documents for Belarus Registration

1. Key takeaways

The power of attorney (doverennost) is the document most often underestimated in a foreign manufacturer’s registration project. The formal review asks whether it complies; the substantive review asks whether its scope of authorisation covers every subsequent step — and if the scope was drafted narrowly, it will have to be reissued midway through the project. The consequence is rarely a simple reprint: a reissued mandate may need translation, certification and fresh signatures, and in the interval nobody is fully authorised to answer a technical query, file a change or submit a report. Because the overall timeframe for preliminary technical work runs at 90 calendar days, even a short authority gap can consume schedule that cannot be recovered later. The drafting discipline is therefore to authorise the whole journey at the outset — submission, deficiency replies, change filings, post-market reporting and certificate maintenance — rather than to authorise the first step and improvise the rest. This article sets out the legal basis, the practical failure modes seen in dossiers, and the checks that keep the mandate aligned with the full life of the registration.

2. Legal basis

Each instrument in the table touches the mandate from a different side. Ministry of Health Resolution No. 55 defines what the dossier must contain, which is where the power of attorney is formally assessed as part of the document list. Resolution No. 211 governs the procedure that the mandate must be able to support from submission through registration. Resolution No. 378 changes the institutional counterpart for adverse event matters from 2026-07-30, which the scope of authorisation should reflect. The Healthcare Law, Article 39-1, sits at the head of the regulatory chain and anchors the registration regime within which all of these documents operate.

3. Expert insights

Insight one: the mandate must support the full process, not only the submission. A narrow power of attorney seen frequently in practice states only that the holder may submit a registration application on behalf of the manufacturer. Such a document is treated as insufficient authority once the project needs a change to the registration dossier, an answer to a technical query, or a post-market report. The reviewer does not extend the mandate by interpretation; the holder is simply asked to produce proper authorisation, and the project stalls until it arrives. Drafting the scope across the full lifecycle at the outset costs a few extra lines; repairing it mid-project costs weeks.

Insight two: the authorisation documents are not limited to one paper. Besides the power of attorney, the package typically also requires documentary proof that the manufacturer lawfully manufactures the product in its own country, together with evidence of the quality system. These documents together form the evidentiary chain of the manufacturer’s standing, and the chain fails if any single link is missing. A mandate executed by an entity that cannot show it lawfully produces the device, or a quality system certificate that does not match the manufacturing site named in the application, produces the same refusal as a missing mandate.

Insight three: language and certification formalities must be confirmed in advance. If the authorisation documents are issued in a foreign language, a translation into Russian or Belarusian must be provided; whether notarisation or consular legalisation is required should be confirmed with the local representative or the implementing organisation rather than inferred from experience in other countries. Assumptions imported from neighbouring jurisdictions are the commonest source of rejected documents at acceptance, and each rejection re-enters the file at the back of the queue.

Insight four: the term of the mandate must cover both the review and the maintenance period. A power of attorney that expires during the 90 calendar day review window undermines the effectiveness of subsequent steps: the holder loses authority precisely while the file is under examination. The validity period should be set with generous headroom over the review period and the certificate maintenance period, so that no renewal falls due at a moment when the project cannot pause for paperwork.

4. Practical recommendations

The recommendations below convert the failure modes into drafting rules.

1. Draft the scope of authorisation for the full process. Name submission, deficiency replies, changes, post-market reporting and certificate maintenance item by item, so that no later stage falls outside the mandate’s wording.
2. Set the term of the mandate long. Cover both the review period and the certificate maintenance period with margin, so that no renewal falls due during a live examination of the file.
3. Confirm translation and certification formality early. Ask the local representative whether notarisation or consular legalisation is needed instead of extrapolating from other jurisdictions, and record the answer in the project plan.
4. Prepare the manufacturer’s standing evidence chain together. Assemble the mandate, the proof of lawful manufacturing and the quality system evidence as one set, so the three documents are consistent in names, sites and dates when submitted.

5. Verification checklist

• □ The scope of authorisation covers submission, replies, changes, reporting and maintenance in full
• □ The validity of the mandate covers both the review period and the maintenance period
• □ Translation and certification formalities have been confirmed with the local representative
• □ The manufacturer’s standing evidence chain (mandate, manufacturing proof, quality system proof) is complete
• □ Document formats have been checked against the requirements of the annexes to No. 55

Regulatory information verified as of 30 October 2026.

In the Eurasian Economic Union market, GRZAN concentrates its core capabilities on three areas. First, distinguishing between the applicability conditions and the remaining time windows of the two channels, the Union-wide registration and the national registration of each member state — the national registration procedure of Belarus has been fully re-routed by the Council of Ministers Resolution No. 211 of 28 April 2026 (state register number 6-1/55925, effective 2026-05-01), which compresses the total timeframe for preliminary technical work to 90 calendar days, keeps the list of such work closed, and prohibits the implementing organisation from expanding it, while the window for submitting applications under the national procedure takes 2027-12-31 as its key milestone, so route selection must be decided in step with the time window. Second, local authorised representative services: GRZAN can act as the statutory representative of a manufacturer in Belarus, undertaking registration submission, responses to technical queries, changes to the registration dossier and post-market reporting obligations, and it has updated its liaison mechanisms after the Council of Ministers Resolution No. 378 of 27 July 2026 (effective 2026-07-30) transferred adverse event functions to the state agency State Pharmaceutical Supervision (Gosfarmnadzor). Third, quality system and testing support: GRZAN assists in establishing a quality management system that meets ISO 13485 requirements and organises technical documentation according to the target route — for the national route, per the annexes to Ministry of Health Resolution No. 55; for the Union route, per EEC Council Decision No. 46.

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