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DIRECTORATE OF REGISTRATION AND REGULATORY AFFAIRS

GUIDELINES FOR CHANGE OF BRAND NAME OF REGISTERED
REGULATED PRODUCTS NAFDAC/RR/011/00

A. GENERAL

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

2. It is necessary to emphasize that no regulated product should 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 name refers to a change in the brand name of a registered product without any change in the product formulation. This could be the company’s instance or NAFDAC instance.

4. Applicants embarking on change of product brand name are not required to complete a new application form.

B. APPLICATION

1. The product must have been registered or may be undergoing registration processing with the Agency.

2. An application shall be made to the Director, Registration and Regulatory Affairs stating the new brand name of the product being applied for.

3.
i. 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) per product name for imported products if the change of name is at the instance of applicants.

ii For locally manufactured products, a fee of thirty thousand naira only (=N=30,000:00) plus 5% VAT in bank draft should apply if change of brand name is at the instance of the company.

iii. There is no fee for change of name prompted by the Agency

4. A formal letter conveying approval of the new brand name should be issued if application is satisfactory

5. The time line for processing should be 10 work days.

C. DOCUMENTATION

1) Copy of NAFDAC registration certificate or evidence of product processing for registration

2) Three (3) vetting samples each of the products in the old and new names (visual artwork is acceptable).

3) Evidence of registration of the new brand name with the Trademarks Registry of the Ministry of Commerce

4) Evidence of payment

D. LABELLING

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

E. All correspondence in respect of change of product name should be addressed to:

The Director,
Registration & Regulatory Affairs
NAFDAC
Central Laboratory Complex
Oshodi, Lagos.

Website: www.nafdac.gov.ng
E-mail address: registration@nafdac.gov.ng
Telephone number: 1-4772452, 01-4748627

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