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DIRECTORATE OF REGULATORY AND REGISTRATION AFFAIRS

GUIDELINES FOR CHANGE OF PLANT ADDRESS FOR
MANUFACTURERS OF IMPORTED REGULATED PRODUCTS
NAFDAC/RR/015/00

A GENERAL
1. These guidelines are for the interest of manufacturers with registered products that relocated their plants to new sites for which a new address have been given.

2. Manufacturers may not source from the new site until an approval has been given by the Agency.

B. APPLICATION
A letter should be addressed to the Director, Registration and Regulatory Affairs Directorate notifying on the new location.

C. DOCUMENTATION
The following documents should accompany the application:

1 Certificate of Manufacture for the new location
a) Issued by a relevant health/regulatory body
b) Authenticated by the Nigerian Embassy in the country of origin. In countries where no Nigerian Embassy exists, British High Commission or any Commonwealth or ECOWAS country commission can authenticate.

2 Current Good Manufacturing Practice (GMP) Certificate of the facility (as applicable)
a) Issued by the relevant health/regulatory body
b) Authenticated by the Nigerian Embassy in the country of origin. In countries where no Nigerian Embassy exists, British High Commission or any Commonwealth or ECOWAS country commission can authenticate.

3. Comprehensive Certificate of Analysis.
a) Issued by the manufacturer.
b) Name and designation of the analyst should be indicated.

4. Current Pharmacists Annual Licence to Practice of the Superintendent Pharmacist issued by the Pharmacists Council of Nigeria.

5. Current Certificate of Registration/Retention of Premises issued by the Pharmacists Council of Nigeria.

6. A letter of Invitation to inspect the new factory which should state the full location address of the manufacturer, Name of contact person, e-mail address, current phone no. & fax no., guide map illustrating the shortest land/air route to the factory.

D. TARIFF
1. The process should attract a fee of one hundred and fifty thousand Naira only plus 5% VAT (=N=150,000:00 + 5% VAT) in bank draft payable to the National Agency for Food and Drug Administration and Control (NAFDAC).

2. All documents must be found satisfactory before any payment is made.

All correspondence in respect of the above should be addressed to:
The Director,
Registration and Regulatory Affairs Directorate,
Central Laboratory Complex,
Oshodi, Lagos.

Website: www.nafdac.gov.ng
E-mail address: registration@nafdac.gov.ng
Telephone number: 01-4748627, 01-4772452, 01-4772455

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