The Closed-List Principle for Preliminary Technical Works in Belarus

1. Key takeaways

Resolution No. 211 does something fairly rare in regulatory practice: it fixes the list of preliminary technical works in writing and expressly prohibits the organising body from expanding it. The government announcement is unambiguous — the specific list of preliminary technical works has been established, and the Republican Unitary Enterprise Healthcare Appraisal and Testing Centre, which is responsible for organising and implementing the works, is prohibited from enlarging that list. For applicants, this changes the character of every conversation about additional requirements. Before the closure, a request from the organising body to add a work item was in effect unanswerable: the applicant had to either perform the work or argue against it from a position with no textual anchor. After the closure, any request for work outside the list can be met with a rule-based objection — the applicant can point to the closed list and ask the organising body to identify where, in that list, the requested work is grounded. The burden has shifted, and with it the negotiating posture of every applicant in the market.

2. Legal basis

3. Expert insights

Insight 1: The rule changes the allocation of the burden of justification. Before the list was closed, when the organising body required an additional work item, the applicant had to argue why the work was unnecessary — a defensive posture with almost no textual footing, since the pre-2026 framework gave no enumeration the applicant could point to. After the closure, the direction reverses: the organising body must show where in the list the requested work sits. This looks like a mere change of wording, but it is a genuine transfer of the burden of argument, and it materially strengthens the applicant’s position in every exchange about scope. To use the shift effectively, however, the applicant must know the list itself well enough to say, concretely, that a demanded item is absent from it. That means the closed list is not only a shield; it is a reason to invest in understanding Resolution No. 55’s enumeration of works before the project starts, not after the first dispute arises.

Insight 2: The carrier of the list is Resolution No. 55, not Resolution No. 211. Resolution No. 211 establishes the principle that the list is closed, but the specific items of the list still reside in Ministry of Health Resolution No. 55 and its annexes. An objection built only on the principle is incomplete: the organising body can properly answer that the requested work is in fact on the list, at which point the applicant needs the text of No. 55 to verify or concede the point. Effective defence therefore always cites both documents together — No. 211 supplies the rule that the list may not be expanded, and No. 55 supplies the factual content of the list. Companies should keep both texts, in current versions, in the project’s regulatory reference set, and should verify the amendment status of No. 55 before each filing, since amendments to its annexes change the factual ground on which any closed-list argument rests.

Insight 3: What is closed is the set of work items, not the depth of each item. The closure prohibits adding work items outside the list; it does not prohibit stricter review of items that are on it. An applicant can still be required to correct deficiencies within a listed work item — for example, a toxicological study may be challenged on its protocol design, sample size or acceptance criteria without any new work item being added. Conflating the two categories weakens the applicant’s credibility: a blanket refusal of every additional request, including legitimate depth requirements within listed items, invites the organising body to dismiss the closed-list argument altogether. The disciplined approach is to sort every incoming request into one of two buckets — an item outside the list, which is contested under No. 211, or a depth requirement inside a listed item, which is handled through the ordinary correction process — and to argue each bucket with its own reasoning.

Insight 4: The value of the principle lies in predictability, not in convenience. GRZAN’s assessment is that the primary commercial value of the closed list is that cost and duration become calculable. A company can enumerate, before the project starts, the test items its product requires and attach a price to each, instead of having the budget grow item by item during review. This matters most in two situations: quoting fixed-fee registration services to an internal business unit or an external client, and bidding for tenders where the registration cost must be locked in months ahead. In both, the closed list converts regulatory scope from an open-ended risk into a defined line item. Companies that internalise this — and reflect it in their quotation assumptions — gain a pricing stability that competitors relying on vague scope descriptions do not have.

4. Practical recommendations

1. Run a list comparison before project kick-off. Enumerate, under Resolution No. 55, the work items this product should undergo and record them as an expected-work list; this becomes the baseline against which every later request is measured.
2. Establish a register for out-of-list requests. For every supplementary requirement received during review, mark it in-list or out-of-list; register out-of-list requests separately and prepare the objection for each.
3. Separate items from depth when objecting. Contest new out-of-list items by citing Resolution No. 211; handle depth requirements on listed items through the normal correction flow. Do not merge the two, and do not oppose everything indiscriminately.
4. Write the closed list into quotation assumptions. State in client quotations that, under the closed-list principle of Resolution No. 211, test items are limited to the list in Resolution No. 55 — this pre-empts later disputes about additional costs.

5. Verification checklist

• □ Expected work list for the product built under Resolution No. 55
• □ Classification register for in-list and out-of-list requests in place
• □ Objection materials cite both Resolution No. 211 (the principle) and Resolution No. 55 (the list)
• □ Distinction established between new items and depth requirements on listed items
• □ Quotations note the closed-list assumption

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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