IN D E X

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LCCI BUSINESS YEAR BOOK 2012
factory is inspected, and a Certificate of
Recognition issued by NAFDAC.
In the case of Imported products:-
* There must be evidence of
registration of such product by the
competent Health Authority of the
country of manufacture i.e. Product
License/Certificate of Registration.
* There must be evidence from the
competent Health Authority, that the sale
of the Product does not constitute a
contravention of the cosmetics Laws that
country i.e Free Sale Certificate
* The documents in respect of (a) and
(b) above shall be authenticated by the
Nigerian Mission in the country.
* In the case of an imported new
substance, there must be evidence that
limited local clinical trials have been
undertaken, and that such product is
registered in the country of origin and
also, in at least e or more developed
countries.
* No combination drug product shall
be registered or considered for
registration unless there is proven
evidence that such a product has clinical
advantage over the single drug available
for the same indications).
* An applicant should indicate the
class or type of registration required
whether it is for a prescription only
product or an over the counter product
* Products found to be of doubtful,
little or no therapeutic value and those
which are sometimes rather harmful and
subject to misuse, shall not be considered
for registration.
* An applicant shall not be allowed to
register a drug formulation in more than
one brand name even where different
doses of the active ingredient(s) are used.
* The product information must be in
Five (5) copies with hard covers per
product (dossiers) made out in
accordance with application format (the
content of the dossier must be in
compliance with the items on the
format).
* All dosage forms of a particular
brand and must contain the same active
ingredient(s) or at least the major active
i n g r e d i e n t ( s ) e . g A c r e a m
B e t a m e t h a s o n e 1 0 m g , A s o a p
Betamethasone20mg
Labeling terms
* Labeling shall be informative and
accurate.
* Minimum requirements on the
package label:
* Name of Product Brand Name and
generic name where applicable. The
generic name must be in similar
characters with the brand name.
* L o c a t i o n A d d r e s s o f t h e
manufacturer.
* Batch No., Date of Manufacture and
Best Before/Expiry Date.
* Dosage regimen on the package.
* Leaflet insert, if prescription
product and hospital packs.
* Indications, frequency, route and
conditions of administration.
* Quantitative listing of all the active
ingredients per unit dose.
* A d e q u a t e w a r n i n g s w h e r e
necessary
* Where a brad name is used, there
MUST be the generic name which
should be conspicuous in character,
written directly under the brand name
e.g VENTOLIN, SALBUTAMOL
* Any drug product whose name,
package or label bears close
resemblance to an already registered
product or is likely to be mistaken for
such registered product, shall not be
considered for registration
* Any drug product which is labeled
in a foreign language shall NOT be
considered for registration unless an
English translation is included on the
label and package insert (Where
applicable).
* Information on indication carried
on packages and leaflet insert of
imported drug product shall not differ
from that in other countries and in
particular the country of origin of the
product.
* Failure to comply with these
requirements may result in the
disqualification of the application or
lead to considerable delays in
processing of registration.
* A successful application attracts a
Certificate or Registration with a
validity period of Five (5) years.
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Note * Failure to comply with these
requirements may result in the
disqualification of the application or lead
to considerable delay in processing of
registration. In case of processed food
and packaged water, only manufacturing
outfits situated in industrial areas will
have their Registration Certificate valid
for 5 years while those located in
residential areas have one year validity
(year listing).
* A successful applicant will be issue a
Certificate of Registration with a validity
period of five (5) years.
* Registration of a product does not
automatically confer advertising permit.
A separate application and subsequent
approval by the Agency shall be required
if the product is to be advertised.
* NAFDAC may withdraw the
Certificate of Registration in the event
that the product is advertised without
express approval from the Agency.
* NAFSAC reserves the right to
revoke, suspend or vary the certificate
during its validity period.
* Filing an application form or paying
for an application fee does not confer
registration status.
* Failure to respond promptly to
queries or enquiries raised by NAFDAC
on the application, will automatically
lead to suspension of further procession
of the application.
Cosmetics General Guidelines
These Guidelines are for the interest of
the General Public, and in particular,
food and beverage industries in Nigeria.
It is necessary to emphasize that no
Processed food shall be manufactured,
imported, exported, advertised, sold or
distributed in Nigeria unless it has been
registered in accordance with Provisions
Of Decree 19 of 1993 as amended by
Food, Drugs and Related products
(Registration) Decree No. 20 of 1999.
Guidelines for Prospective Agents of
Foreign Manufacturers of Regulated
Products
Again, it needs to be emphasized that it is
unlawful to import into Nigeria any
regulated product not duly registered by
N A F D A C . A g e n t s o f f o r e i g n
manufacturers are to take the necessary