Friday, February 24, 2017


By now I believe you’re familiar with the step by step involve in registering any product with NAFDAC. Having known that, let’s talk about those things that may cause your registration process halted or rejected entirely. Products getting compliance are the major challenges people face while registering their products. It has cost and time implications. For most people, it takes weeks or even months to comply with the directives given to them, depending on the nature of the compliance. On the other side, if it require for change of document, that is additional cost to you plus time wastage. So, when you hear people say such things like; it is difficult, frustrating and time consuming to register products with NAFDAC, this is the cause. In fact, the essence of writing this report, hinges on this aspect. So I’m handing over to you what has made many to consider NAFDAC as no go area. Now, enough of story, let’s go into details of those reasons.
i.                   Incomplete documents required. There are must have documents for each product registration. That is why NAFDAC lists all the necessary documents needed to register each product. If anyone is missing, know that compliance will be given or registration turned down. I employ you to make sure that all the documents are complete before thinking of approaching NAFDAC for registration. For this reason, I’ve included the downloaded packages for each product from NAFDAC, so use the one that is meant for you.
ii.                 Expiry documents. If any of the document presented, has expired, this causes the compliance directives. This is mostly common with the imported products. For instance, Power of Attorney, Manufacturing License, GMP, COPP, Free sales certificate etc. Make sure that the validity dates of the documents are long enough. I’m saying this because, you may submit document(s) that its validity date is okay, but expires during the registration process, compliance will be issued at the stage it expired once it’s noticed. You may say after all I submitted when it still okay. No, NAFDAC doesn’t consider such thing. Remember, I told you in the previous sections that your product can get compliance directives at any
           stage. It may successfully pass one stage, only to get compliance
               in another stage. This is one of the reasons.
iii.              Information on the document(s) not specific. There is where there are contradictions in the information the documents carry. For instances, (a) where the name and address of manufacturer in the Power of Attorney contradicts with other documents. (b) Where the agreement between the applicant and the partner is not specific e.g who owns the trade mark; is the applicant authorized to register the product(s) with the NAFDAC. (c) If the product is freely sold in the country of origin and can sold in the other countries. (d) If the applications are not addressed specifically to NAFDAC. I’ve seen some documents addressed to ministry of Health or ministry of commerce and industry and the registration was rejected because of that. So inform your partner to address any letter to DG NAFDAC specifically.
iv.              Documents not Notarized/Authenticated. This is where any of the documents issued by the manufacturer is not notarized by the notary public in the country of origin and/or authenticated by Nigeria Embassy in that country. Ensure that the necessary documents are notarized and authenticated appropriately.
v.                 Brand Name/Trademark Issue. There are cases that arise with regard to trademark registered ranging from (a) who owns the brand name. (b) Pass-off. If the brand name sounds alike to already registered product. (c) When name registered is not ideal. Some will bring names that are deceptive or meaningless. I’ve seen names like Satan will submit, men follow, Emeka vitamin C and other funny names like that. Such names are not acceptable by NAFDAC. Your brand name should at least have element of generic name of the product in it. My advice is to carry out name search with NAFDAC before registering your trademark, unless you’re creative enough to craft unique name. It only cost N2500 + 5% VAT for each name search. This will save you thousands of Naira and time.
vi.              Ceiled/Banned products. If any product is among the lists of drugs, foods, cosmetics and chemicals that are ceiled by NAFDAC not to be registered or banned by Federal Government from being imported into the country, definitely the registration will be rejected. This is done to encourage local manufacturers. So check
          for the lists before thinking of the process of registration. They are
          available at the NAFDAC office.
vii.            Product labels. There are minimum information each product labeling is required to carry. E.g Manufacturer’s address, batch No, production and expiry date, provision for NAFDAC Reg NO (must be written like this: NAFDAC REG NO:), pack sizes, Net contents e.t.c. The labels must be informative and must be written in English language. Where the label is written in any other language, it must be transcribed in English.
viii.         Information in the Leaflet. This is especially for drugs. There are minimum information the leaflet must carry. E.g Composition, presentation, indication, dosage and administration, side effect, contraindication, pharmacology, manufacturer’s address etc.
ix.              Factory Layout/Equipment. This is for locally manufactured products. Those basic requirements have to be in place before inviting NAFDAC for product inspection. This is where many small businesses find it difficult to meet.

Sunday, January 9, 2011


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        
(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  
(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        
(j)    Valid pharmacists premises license to practice issued by pharmacists council of     
(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

Tuesday, January 4, 2011


Stages involve to register products with NAFDAC in Nigeria is procedural. Every process needed to register any product must be followed to the later.First, know that NAFDAC categories registration of products basically into two parts; namely, imported products and locally manufactured products. Again, each part has classes under which products are registered such as Drugs, Foods, Cosmetics, Medical Devices, Herbal products, Narcotics, Pesticides, Packaged Water e.t.c.
Now, there five(5) stages each imported product must pass in order to license number:

Stage one: Documentation:
Here you are required to present the necessary documents specified by NAFDAC to register each products. These documents differ in some aspect depending on the class of product you want register. Some of the documents include Power of Attorney or contract manufacturing Agreement; Manufaturing license and free sale certificate, Trademark registration,certificate of incoporation/business name and many more.
Note: All the necessary documents must be found satisfactory before any other process can be carried out. 
Stage two: Import Permit:
If the documents complied with the NAFDAC requirements, permit to import samples of products is issued to the applicant. The applicant is requited to import specified samples to be used for vetting and Lab analysis.

Stages Three: Vetting of samples:
At this stage, samples of products presented are vetted. Such vetting includes checking the labels, leaflets, drugs information. There are minimum requirements for product labeling such as name of the medicine brand name, name and address of the manufacturer, production and expiry date, batch no, provision for NAFDAC NO and so on.
Documents to be submitted during the vetting are:
a. copies of import permit and receipt of payment
b. dossier according to NAFDAC format for drugs and pesticides
c. 3 samples for each product
d. Letter of invitation for inspection.
e.      Comphrensive Certificate of Analysis

Stage Four: Lab Analysis:
After the vetting is done, you are required to bring some samples for lab analysis. You’ve to submit specified quantities of sample products along with copies of receipt for the processing fee and application letter for the submission of samples. Then your product(s) goes to lab for analysis to ensure compliance with standard specification.

Stage Five: Meeting:
At this stage, if the product(s) successful meets the lab test, then the product will be presented at the meeting. Here, decisions are taken on whether the product qualifies to be given NAFDAC license Number or not. They usually seat two times over the product. If the product meets all the requirements, license number will be issued.

Stage Six: Collection of Notification Number:
Once the product is given license number, you will go ahead to collect the notification number. You’ve to pay the specified amount for the license certificate and present the receipt and your notification number will be given to you. You are now qualified to import the product for commercial purpose while you wait for the certificate to come out. It takes six months or so for your certificate to be ready. The certificate usually last for the period of five (5) years.