Query Closure and Clock-Stop Rules under NAFDAC Registration

1. Key takeaways

Nigeria’s rules on queries and enquiries amount to only two sentences, but both are hard procedural constraints that directly determine whether an application survives.

The first sentence — no response means closure.

• The 2025 guideline VBM-R&RA-GDL-001-01 §11.6: failure to respond promptly to queries or enquiries raised by NAFDAC on the application (within 90 days) will automatically lead to the closure of the application;
• The 2024 guideline R&R-GDL-008-02 §12.6: the equivalent wording is 90 working days.

The second sentence — the clock stops.

• The 2025 guideline §11.8 and the 2024 guideline §12.8: note that once compliances are issued, the clock stops.

Taken together, the practical meaning is this: after the authority issues a compliance instruction, the processing timeline stops running; but if the applicant fails to respond for a long period, the application will be closed — the consequence is closure, not continued waiting. The two rules operate on different clocks and must be managed separately, because the closure rule continues to run while the processing timeline is suspended. A project that treats the two clocks as one will discover, usually late, that an application can be procedurally alive in one sense and already closed in another.

2. Legal basis

3. Expert insights

Insight one: 90 days and 90 working days are two different measures; manage against the shorter one.

Ninety working days, at five days per week, converts to roughly eighteen calendar weeks; ninety calendar days is roughly three months. The gap is nearly a factor of two. GRZAN’s practice is to set an internal red line at 90 calendar days and an escalation line at 60 calendar days, so that neither measure can be breached unnoticed. The escalation line matters as much as the red line: it forces the question of whether evidence can still be assembled in time while there is room to ask NAFDAC for an extension in writing.

Insight two: Regulation 4(4)(a) gives the authority the power to request additional information — that is the legal basis of a query.

Regulation 4(4)(a) provides that in considering an application the authority may require the applicant to supply such further information as it needs to reach a decision. A query is therefore not an extra step but part of the statutory review procedure; the consequences of non-cooperation appear directly in the refusal grounds of Regulation 4(10) and in the automatic closure wording of the guidelines.

Insight three: closure is not refusal, but it is just as costly.

Closure and refusal are two different outcomes: refusal carries the statutory grounds in Regulation 4(10) and the written notification requirement of Regulation 4(6); closure is a procedural termination. For the company, however, both mean that the application fee already paid and the time already spent are not refunded (the guidelines further state that payment does not create any registration status).

Insight four: the clock-stop rule actually favours the applicant, but it is easily misread as permission to delay.

The clock suspension protects the authority’s timeline commitment; it does not give the applicant an open-ended grace period. The 90-day red line keeps running during the suspension, counted from the date the query is issued. Reading the clock stop as an invitation to answer slowly is the most common misjudgement seen in Nigerian projects.

Insight five: queries usually point to reasoning that is insufficient, not to one missing page.

Measured against the dossier compilation guideline, failing to provide required information may lead to the dossier not being accepted, serious delay of the evaluation, or discontinuation of the evaluation process. A high-quality first submission that completes the full argument chain in one pass is therefore more effective than a strategy of rapid piecemeal supplementation. Companies that habitually answer queries with short, minimal responses tend to accumulate several rounds, and each round restarts the same calendar cost.

4. Practical recommendations

1. Maintain a query register recording the issue date, the response deadline (set at 90 calendar days), the responsible person and the escalation point (60 calendar days).
2. Manage internally against the shorter measure, so that no dispute arises over working days versus calendar days.
3. Write the complete argument chain in the first submission, minimising the probability of queries.
4. Map every response point by point to the query numbers, citing the page numbers of supporting evidence, to reduce back-and-forth.
5. If the red line is approaching and evidence is incomplete, proactively explain in writing and request an extension; never wait silently.

5. Verification checklist

• □ A query register is in place, recording the issue date and deadlines under both measures.
• □ The internal escalation line is set at 60 calendar days, ahead of both red lines.
• □ The legal basis of queries has been confirmed as Regulation 4(4)(a) (additional information may be required).
• □ The team understands that the clock stop is not permission to delay.
• □ Response letters map point by point to query numbers and cite evidence page numbers.
• □ A full self-check of the argument chain was completed before the first submission.

Regulatory information verified as of 29 October 2026. All citations above were checked against the registration guidelines published on the NAFDAC website (VBM-R&RA-GDL-001-01 §11.6 and §11.8; R&R-GDL-008-02 §12.6 and §12.8) and the regulation text (S.I. No. 42 of 2024, Regulations 4(4)(a) and 4(10)); this page is reviewed whenever the regulations are updated.

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