Displaying the NAFDAC Registration Number across Packaging Levels in Nigeria

1. Key takeaways

The rules for displaying the registration number (NAFDAC REG. NO.) are set out in Regulation 23 of the Regulations, and the labelling rules add three operating points. Together they determine which packaging level carries the number — a question that decides artwork structure for every product line.

1. Regulation 23(1): the packaging components of devices, IVDs and related products must clearly display, in the manner prescribed by the Agency, the registration number (NAFDAC REG. NO.) as it appears on the registration certificate;
2. Regulation 23(2): where a device has tertiary, secondary and primary packaging materials, and the contents of the unit pack may reasonably be regarded as dispensed or sold as a whole to the end user, or are for single use, the registration number need only be displayed on the tertiary and secondary packaging materials;
3. Regulation 23(3): where the primary packaging is itself the Trade Item, the registration number must be assigned to the primary packaging.

IVDs carry a supplementary point: where the name and postal address of the authorised applicant, local technical representative (LTR), importer or distributor are provided by the manufacturer, the additional label must not obscure any label of the manufacturer. This single sentence has real artwork consequences for imported IVDs, because the local information cannot simply be layered over the original label wherever space happens to remain; the placement must be designed before the artwork is finalised, and verified again whenever the artwork is revised.

The three limbs of Regulation 23 should be read in order: first classify the packaging structure, then test whether the relief in 23(2) is available, and only then decide where the number goes. Skipping the classification step is the most common cause of mislabelling found at port inspection.

2. Legal basis

3. Expert insights

Insight one: the Regulations define the three packaging layers first, which is what makes the classification exercise evidence-based. Regulation 51 provides: primary packaging material means packaging in direct contact with the product (bottles, blister foils, aluminium foil and the like); secondary packaging material means material enclosing the primary packaging; tertiary packaging material means the outer carton holding multiple saleable units (the shipping carton). Companies should first classify their own packaging structure against these definitions and only then apply Regulation 23. The classification should be documented per product, because inspectors and port officers will apply the same definitions when they form their own view, and a written rationale removes the scope for disagreement.

Insight two: Regulation 23(2) is a relief clause, but it has two alternative preconditions. The preconditions are: (a) the contents of the unit pack may reasonably be regarded as dispensed or sold as a whole to the end user; or (b) the product is for single use. Where the preconditions are met, the registration number only needs to reach the tertiary and secondary packaging. If the product is a multi-dose or repeated-use format from which users draw multiple times, the relief clause cannot be invoked automatically. The evaluation should be recorded in the design dossier, because it is exactly the kind of judgement an inspector will re-test against the physical product on the shelf.

Insight three: where the primary packaging is the trade item, the registration number must reach the primary level. Regulation 23(3) addresses the situation of a single retail unit that is itself the primary packaging (for example, a single-unit retail pack). In that case the number cannot appear only on the shipping carton — this is a common mislabelling point for imported products, where the export carton carries the number but each retail unit does not. Correcting this after arrival means re-labelling in-country, which multiplies cost and introduces its own compliance questions.

Insight four: additional labels on IVDs must not obscure the manufacturer’s labels. The labelling rules for IVDs provide that where the name and postal address of the authorised applicant, LTR, importer or distributor are supplied by the manufacturer, the additional label should not obscure any label of the manufacturer. For imported IVDs this means the position of the local information sticker must be designed in advance, not applied on arrival wherever space is left. A sticker that covers the expiry date, batch number or UDI of the original label destroys traceability and invites detention.

Insight five: the registration number and registration status are two different things. The guidelines are explicit that submitting an application or paying the application fee does not itself confer registration status (2025 guideline §11.5 / 2024 guideline §12.5). Therefore NAFDAC REG. NO. must not be printed before the registration certificate has been obtained — and against Regulations 47(1) and 48, doing so is a risk of criminal-penalty magnitude. Marketing teams and printers should be told this explicitly, because the request to add the number often originates outside the regulatory department.

4. Practical recommendations

1. First classify the packaging structure as primary, secondary or tertiary under the Regulation 51 definitions, then determine the display level.
2. Test the two preconditions of Regulation 23(2) (dispensed as a whole to the end user, or single use) and document whether the shipping-carton-only option is available.
3. For products whose primary packaging is the trade item, place the registration number on the primary packaging.
4. Design the placement of locally required information on imported IVDs in advance, ensuring no manufacturer label is obscured.
5. Do not print NAFDAC REG. NO. before the certificate is issued, to avoid constituting false marking.

Each of these points costs little to implement at artwork stage and is expensive to fix after shipment. Build the classification decision into the artwork approval form so it is signed, dated and stored with the artwork history.

5. Verification checklist

• □ The packaging structure has been classified under the primary, secondary and tertiary definitions.
• □ Whether the relief preconditions of Regulation 23(2) are met has been assessed.
• □ Where the primary packaging is the trade item, the registration number appears on the primary packaging.
• □ The registration number format matches the content of the registration certificate.
• □ IVD additional labels do not obscure the manufacturer’s labels.
• □ NAFDAC REG. NO. is printed only after the registration certificate has been obtained.

Regulatory information verified as of 29 October 2026. All provisions cited above were checked against the Regulations (S.I. No. 42 of 2024, Regulations 23 and 51), the labelling rules and the registration guideline (VBM-R&RA-GDL-001-01 §7.0; §11.5) as published on the NAFDAC website; this review is refreshed whenever the regulations are updated.

GRZAN supports manufacturers entering the Nigerian market with registration documentation and conformity files, including classification determination, registration pathway selection, technical documentation to the IMDRF ToC, GMP and foreign inspection readiness, advertisement permits, vigilance and PMS reporting, change management and renewal. Local resources in Nigeria cover licensed import entities and authorised representative services, NAPAMS online submission, dossier screening permit liaison, import permits, sample delivery and laboratory analysis support. Contact: hito.lin@grzan.cn; website www.grzan.cn.