NAFDAC Registration Timeline: 120 or 240 Working Days?

1. Key takeaways

Nigeria currently has two official timeline benchmarks that can be consulted at the same time, and any citation must carry the document reference and its date. The two figures are set out below.

GRZAN schedules on the basis of the 240 working days of the 2025 VBM guideline, on the grounds that this guideline was issued by the VBM-R&RA Directorate, which now handles device registration, and has the later effective date. At the same time, the 120 working days of the 2024 guideline is stated truthfully wherever the older benchmark is relevant.

One circulating claim must be clearly rejected: the tiered statement found online and in some industry materials, to the effect that Class A takes 120 working days and Classes B/C/D take 240 working days, does not appear in either of the two official NAFDAC guideline texts verified for this review. That tiering is handled as a practical estimate and is not presented as a conclusion.

2. Legal basis

3. Expert insights

Insight one: the two figures are not a contradiction but two versions coexisting.

Both guidelines are published in the guideline section of the NAFDAC website, and neither declares the other repealed. The difference lies in the responsible directorate: R&R-GDL-008-02 comes from the former Drug Registration and Regulatory Affairs directorate system, while VBM-R&RA-GDL-001-01 comes from the VBM-R&RA Directorate that has taken over device registration. For scheduling, companies should adopt the newer and functionally relevant guideline and document internally why that choice was made.

Insight two: 240 working days is a maximum, not an average.

The wording of the 2025 guideline at §11.7 is a maximum of two hundred and forty (240) work days. This is an upper-bound commitment; the actual duration depends on dossier quality, whether queries are raised, and arrangements for overseas inspections. Conversely, the wording of the 2024 guideline at §12.7, is one hundred and twenty (120) working days, is declaratory in tone and reads closer to a target value than a binding cap.

Insight three: the timeline counts only acceptance to issuance, not the stages before or after.

The wording of both guidelines is from acceptance of submissions to issuance of the registration number. Preparatory actions such as the Dossier Screening Clearance, the import permit application and sample shipment are therefore not counted within these 120 or 240 working days. Companies must add the front-end segment to the total duration separately when planning.

Insight four: the clock-stop rule is the official position that the query period does not count against the authority.

§11.8 and §12.8 state: please note that the clock stops once compliances are issued. For companies this cuts both ways. The benefit is that the authority does not pad its timeline with the applicant’s query-response time; the drawback is that every query extends the total calendar duration, while sample shelf life, warehousing and staffing costs keep accruing in parallel.

Insight five: the regulation layer sets no working-day deadline; the timeline exists only at guideline level.

Regulation 4 of S.I. No. 42 of 2024 governs the procedure for application, review, decision and issuance but contains no working-day figure. The timeline commitment therefore belongs to the guideline layer, with weaker legal enforceability than the regulation. Follow-ups should cite the guideline, not assert a statutory deadline.

4. Practical recommendations

1. Adopt 240 working days as the single internal planning benchmark, and state in external documents that the basis is VBM-R&RA-GDL-001-01 §11.7 (effective 10 April 2025).
2. Add the front-end segment (dossier screening, import permit, sample shipment) to the total duration separately; do not fold it into the 240.
3. Reserve a buffer for each round of queries (clock suspension), and model one query as one additional block of calendar time.
4. Do not cite the unattributed tiered claim of 120 for Class A and 240 for B/C/D externally; if it must be mentioned, label it as a practical estimate.
5. Chase progress by citing the guideline provisions, not a statutory deadline, and keep written records of all exchanges.

5. Verification checklist

• □ The planning benchmark has been fixed at 240 working days, with the source document and effective date noted.
• □ The Dossier Screening Clearance, import permit and sample shipment are listed as a separately timed front-end segment.
• □ A query-response mechanism is in place to avoid crossing the 90-day closure line.
• □ The team is aware that the clock stops when compliances are issued, and of the effect on calendar duration.
• □ No unattributed tiered timeline statements appear in external documents.
• □ The two layers — regulation-level procedure and guideline-level timeline — are kept distinct.

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

GRZAN support for the Nigerian market: GRZAN coordinates local licensed import entities and authorised representative resources in Nigeria, covering online submission on NAPAMS, liaison for the Dossier Screening Clearance, import permits, sample delivery and laboratory analysis support. Service capabilities include classification decisions, selection of the registration pathway, preparation of technical documentation on the IMDRF ToC, handling of the CMFS and notarisation or legalisation, GMP and overseas inspection readiness, advertisement permits, vigilance and PMS reporting, variation management and renewal. Contact: hito.lin@grzan.cn; website www.grzan.cn.