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.