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DIRECTORATE OF REGULATORY AND REGISTRATION AFFAIRS

GUIDELINES FOR CHANGE OF PRODUCT PACKAGE LABEL DESIGN OF
ALL REGULATED PRODUCTS IN NIGERIA
NAFDAC/RR/013/00

A. GENERAL
1. These guidelines are for the interest of the general public and in particular companies in Nigeria that 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 (formerly decree 19 of 1993) and the accompanying guidelines.

3. Change of package design refers to any change(s) in the design of an already registered product (colour, shape, labeling) without change in the product formulation.

4. Where there is a change in the primary packaging, a laboratory evaluation of the product may be required to ensure that the stability and shelf life of the product are not compromised due to the change.

5. Applicants embarking on change of package design are not required to complete a new application form.

B. APPLICATION
1. A product for change of package design must have been registered by NAFDAC and assigned a NAFDAC Registration Number.

2. An application shall be made to the Director, Registration and Regulatory Affairs, stating name of the product, generic name, brand name (where applicable) and name of manufacturer.

3. A formal letter conveying approval of the new pack design shall be issued to the applicant if application is satisfactory.

C. DOCUMENTATION AND OTHER REQUIREMENTS

1. Copy of NAFDAC registration certificate of the product.

2. Three (3) vetting samples each of the old product and new design (visual artwork acceptable).

D. LABELLING
The labeling information must be as originally approved in compliance with the Agency’s labeling regulations (as applicable).

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

F.  Time line for processing is ten (10) work days.
All correspondence in respect of change of package design should be addressed to:
The Director,
Registration & Regulatory Affairs
NAFDAC, Oshodi, Lagos.
Website: www.nafdac.gov.ng
E-mail address: registration@nafdac.gov.ng
Telephone numbers: 01-4772452, 01-4748627

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