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.
