NAFDAC REGISTRATION: THE MUST HAVE DOCUMENTS TO REGISTER IMPORTED DRUGS

To register imported drugs and other related products with NAFDAC, there are basic documents
and requirement you must have. These requirements must meet NAFDAC set standard. They
include the followings:  

(a)    Power of Attorney or Contract Manufacturing Agreement. This is legal agreement      
  between manufacturer and applicant. It must be Notarized by Notary Public in the        
country of manufacture and issued by the manufacturer of the products which is duly        
signed by most senior management.
(b)    Manufacturing License/ Certificate (for India and China Only). This is a license or 
       certificate issued by relevant authority in the country of manufacture that empowers 
       the manufacturer to produce such drug products. It also state that the product       
 produced are sold in the country of origin and can be freely sold in other        
countries.
(c)    Certificate of Pharmaceutical Products ( COPP; WHO FORMAT)
(d)    Current Good Manufacturing Practice (GMP) Certificate of the manufacturing facility.
Note: Nos; b,c & d  shall be issued by a relevant health /regulatory body and authenticated 
      by the Nigeria Embassy in the country of origin. In countries where no Nigeria Embassy
      exists, British High Commission or any Commonwealth or ECOWAS country commission can  
      authenticated.
(e)    Brand Letter Confirmation. This issued by manufacturer if the brand name(s) belong  
      to the applicant stating that the brand name(s) belong to the applicant and the       
 applicant should go ahead to register it with NAFDAC.
(f)    Comprehensive Certificate of analysis: issued by the manufacturer with the name and 
       designation of the analysts.
(g)    Certificate of registration of brand name with the trademark Registry in the        
ministry of Commerce in Nigeria.
(h)    Certificate of incorporation with Corporate Affairs Commission in Nigeria .
(i)    Current pharmacists License to practice issued by the pharmacists council of        
Nigeria.
(j)    Valid pharmacists premises license to practice issued by pharmacists council of     
   Nigeria.
(k)    Application letter for import permit by the applicant.
(l)    Notarized Declaration stamped by notary public here in Nigeria.
(m)     A letter of invitation to inspect the factory abroad. This is submitted by the      
applicant and shall state the full location address of the manufacturer, name of        
contact person, e-mail address, phone and fax numbers and nearest airport; and also         
the full name and address of the applicant