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DIRECTORATE OF REGISTRATION AND REGULATORY AFFAIRS
GUIDELINES FOR PACK SIZE EXTENSION OF ANY REGULATED PRODUCT
NAFDAC/RR/014/00

A. GENERAL
1. These guidelines are for the interest of the general public and in particular, companies in Nigeria that have registered regulated products with the agency.

2. It is necessary to emphasize that, no regulated product shall be manufactured, imported, exported, advertised, sold or distributed in Nigeria unless it has been registered in accordance with the provisions of Act Cap F33 LFN 2004 (formerly decree 19 of 1993) and the accompanying guidelines.

3. Pack Size Extension refers to introduction of new net contents of already registered products which could be in packages as originally registered or in new primary packages e.g. bottles, jars, blisters, etc.

4. Where there is a change in the primary package of a product requiring size extension, a laboratory evaluation should be done to ensure that the product quality is not compromised.

5. Applicants embarking on pack size extension are not required to complete new application form.

B. APPLICATION
1. A product for pack size extension must have been registered by the Agency and assigned a NAFDAC Registration Number.

2. An applicant should submit a formal application letter to the Director, Registration and Regulatory Affairs stating name of the product, (generic name), brand name (where applicable) and name of manufacturer.

3. Applicant should pay the prescribed fee of fifty thousand Naira only (=N=50,000:00) plus 5% VAT in bank draft in favour of NATIONAL AGENCY FOR FOOD & DRUG ADMINISTRATION & CONTROL (NAFDAC).

4. A formal letter conveying approval of the new pack extension (s) should be issued to the applicant if application is satisfactory.

C. DOCUMENTATION.
1. Evidence of NAFDAC registration of the product.
2. Three (3) vetting samples each of the new pack extension.
3. Evidence of receipt of payment.

D. LABELING
Labeling must be as originally approved in accordance with the Agency’s labeling regulations (as applicable).

E. All correspondence in respect of pack size extension should be addressed to:

The Director,
Registration & Regulatory Affairs
NAFDAC
Central Laboratory Complex
Oshodi, Lagos.
NAFDAC website: www.nafdac.gov.ng
e-mail address: registration@nafdac.gov.ng
Telephone number: 01-4772452, 01-4748627

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