Adverse Event Reporting after 30 July 2026: Gosfarmnadzor Takes Over in Belarus

1. Key takeaways

From 30 July 2026, the collection, registration, analysis and notification to the Ministry of Health of adverse event information related to the use (operation) of medical devices in Belarus is handled by the State Institution for State Pharmaceutical Supervision (Gosfarmnadzor), and is no longer the responsibility of the Unitary Enterprise Center for Expertise and Testing in Healthcare. The body to which manufacturers submit adverse event reports changes accordingly. Nothing in the reporting obligation itself disappears, and the procedural instrument approved by Resolution No. 177 remains in force. What changes is which authority receives and processes the information, and that single change has practical consequences for every contact point, acknowledgment mechanism and escalation route that a manufacturer has built around post-market vigilance in Belarus. Companies that fail to redirect their submissions risk having reports filed with an authority that no longer owns the function, which in turn weakens the evidentiary value of their compliance records. This article explains what Resolution No. 378 changed, what it deliberately left untouched, and how manufacturers should reorganize their reporting workflows so that every adverse event detected after 30 July 2026 reaches the correct authority within the applicable framework.

2. Legal basis

3. Expert insights

Insight 1: this is a change of receiving window, not a cancellation of the obligation. The adverse event reporting obligation itself continues to exist, and its procedural carrier — the regulation approved by Resolution No. 177 — remains fully valid. What has moved is only the authority that receives and processes the reports. When manufacturers update their internal procedures, the work therefore concentrates on changing the recipient and the contact persons, not on redesigning the content of the reports. Companies that treat the transfer as a reason to pause or rewrite their vigilance system are spending effort in the wrong place; the faster and cleaner the redirection of the submission channel, the lower the compliance risk in the transition period.

Insight 2: the transferred functions go well beyond adverse events. Resolution No. 378 simultaneously transfers to the new authority the inspection of the quality and safety of medicines and medical devices (including devices that have been seized, impounded or nationalized), the registration of maximum ex-factory prices of medicines, the maintenance of the database of substandard and counterfeit medical devices, and the administrative procedure for conclusions on the qualification to repair and maintain medical equipment. This means that the surface of contact between a manufacturer and Gosfarmnadzor will expand significantly. A company that previously dealt with one expert body for review matters and a separate enterprise for post-market matters now faces a single supervisory institution across most of the circulation cycle.

Insight 3: the legislative purpose of the transfer is to strengthen the effectiveness of supervision. The government press service explained that the move is intended to ensure effective supervision of the circulation of medicines and medical devices. Viewed from the perspective of regulatory design, separating technical review (an expert body) from post-market supervision (a supervisory body) is the classic separation of technical and enforcement functions. Manufacturers should expect the enforcement character of the post-market phase to increase, and should align their documentation quality, response speed and escalation discipline with that expectation rather than with the former expert-enterprise relationship.

Insight 4: the specific national reporting time limits must be confirmed against the national provisions. The Union-level monitoring rules set tiered deadlines by the severity of the event (see the article on Union monitoring rules in this series), but the specific number of days in the Belarusian national regulation has not been obtained in official source text by GRZAN, and this series treats it as pending verification. Union figures must not be applied on their own as national statutory deadlines. Until the national figures are confirmed, the prudent course is to work to the shortest applicable Union timeline as an internal target while keeping the national requirement as the formal reference point.

4. Practical recommendations

1. Update the recipient in the submission workflow. Redirect all adverse event submissions to the State Institution Gosfarmnadzor, and rebuild the contact-person list, the acknowledgment mechanism and the escalation route around the new recipient before the first report after the transfer date is due.
2. Build a cross-agency affairs list. List every function transferred by Resolution No. 378 — quality and safety inspections, price registration, the counterfeit database, repair and maintenance qualification conclusions — and confirm, item by item, the responsible counterparty and the submission window for each.
3. Keep records spanning the changeover date. For reports that straddle 30 July 2026, retain submission receipts and timestamps on both sides of the date, so that point-in-time compliance can be demonstrated if the choice of recipient is ever questioned.
4. Confirm the national reporting deadlines in writing. Ask the local representative to confirm the specific number of days in the national regulation, and do not substitute Union figures for the national statutory deadlines in any formal procedure document.

5. Verification checklist

• □ The recipient of adverse event submissions has been updated to Gosfarmnadzor
• □ A cross-agency affairs list has been built and each liaison window confirmed
• □ Submission evidence for reports spanning the changeover date has been retained
• □ The national reporting deadlines have been confirmed in writing with the local representative
• □ Awareness is documented that Resolution No. 378 entered into force on 2026-07-30

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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