Advertising Approval under Law No. 225-Z in Belarus

1. Key takeaways

Advertising of medical devices and medical equipment in Belarus may be placed only after consent has been obtained from the Ministry of Health. The exceptions are narrow and confined to professional settings directed at medical and pharmaceutical personnel: placement at exhibition venues and the like, or publication in professional print media included on the list approved by the Ministry of Health. Everything aimed at the public — including all online channels — falls outside the exception and needs approval. Two practical consequences follow. First, the approval is a distinct administrative service with its own named service item and its own timeline, so marketing calendars must schedule it as a separate step rather than assuming it travels with the registration. Second, approval presupposes registration: the advertising content must stay within the registered product information, so the compliance review for any campaign is a comparison against the certificate and the register, not merely against the marketing brief. Campaigns planned before the approval path is confirmed run the risk of media bookings that cannot lawfully run on schedule.

2. Legal basis

The first row is the operative rule: Article 15 of the Advertising Law No. 225-Z of 2007-05-10 makes Ministry of Health consent the general condition and defines the narrow professional exception. The second row shows that the approval is an institutionally provided service, listed by name on the expert institution’s service list. The remaining rows locate the rule in the wider regime: registration bounds what the advertising may claim, and the 2026 functional adjustments sit alongside as institutional context. Together the rows show both the legal requirement and the concrete administrative route through which it is satisfied.

3. Expert insights

Insight one: advertising approval is a fee-charging service explicitly listed in the institution’s service list. The expert institution lists on its website the item covering approval of advertising of medicines, medical devices, medical equipment and the related categories. This means the approval has a defined intake path; it is not a vague case-by-case matter. When scheduling market promotion, companies should treat approval as an independent step with its own lead time and fee, sequenced before media bookings rather than discovered during them. A campaign plan that names the approval as a milestone is auditable; one that assumes it implicitly is not.

Insight two: the boundary of the exception is doubly limited, by audience and by channel. The exception in Article 15 applies where the audience consists of medical and pharmaceutical personnel, and the channel is limited to exhibition venues and comparable settings, or to professional print publications on the Ministry of Health’s approved list. Any channel aimed at the public, including online placements of every kind, falls outside the exception. Marketing teams should therefore classify each planned placement by both dimensions — who sees it and where it appears — because a professional audience reached through a public channel still requires approval.

Insight three: advertising content must not exceed the registration scope. Approval presupposes that the product has completed registration, and the advertising content must correspond to the registered information. Advertising an unregistered product cannot be approved at all and may itself constitute a violation. The practical discipline is to draft campaign copy from the certificate and register entry rather than from global marketing materials, checking product name, intended use and registration details item by item before the file goes for approval.

Insight four: the approval authority and the registration authority may be the same institution, but the procedures are independent. Although the advertising approval and the preliminary technical work for registration are both handled by the expert institution, they are separate service items. No assumption should be made that registration approval implies advertising approval: the files are separate, the fees are separate and the lead times are separate. Treating them as one approval is a scheduling error that surfaces as a blocked campaign launch.

4. Practical recommendations

The recommendations below embed the approval into campaign planning as a controlled step.

1. Schedule advertising approval into the promotion plan. Reserve time and budget for it as an independent step, keeping it separate from the registration workflow and its timeline.
2. Confirm first whether the audience and channel fall within the exception. Treat all public-facing promotion as requiring approval by default, regardless of the professional standing of parts of the audience.
3. Align advertising content with the registration information. Check product name, intended use and registration details item by item, so that no claim exceeds what the registration supports.
4. Retain the approval documents. Archive the granted approval as evidence of placement compliance, available for any later inspection of the campaign.

5. Verification checklist

• □ It has been confirmed that advertising requires Ministry of Health consent under Article 15 of the Advertising Law No. 225-Z
• □ Whether the audience and channel fall within the professional setting exception has been checked
• □ Advertising content has been aligned with the registration information
• □ Advertising approval has been scheduled into the promotion plan as an independent step
• □ The approval documents have been archived

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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