IN D E X

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LCCI BUSINESS YEAR BOOK 2012
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
product, there must be evidence that
such product is registered in the
country of origin, and that the
ingredients are approved raw
materials.
* An applicant shall not be allowed to
register a cosmetic product in more
than one brand name, except in cases
where the manufacturers are
different having different brand
names for the same formulation.
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.
* Adequate warnings where necessary
* Where a brad name is used, there
MUST be the generic name which
should be conspicuous in character,
written directly under the brand
n a m e e . g V E N T O L I N ,
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 years.
NOTE * Failure to comply with these
requirements may result in the
disqualification of the application
areas or lead to considerable delay
in processing of registration.
* In case of processed food and
p a c k a g e d w a t e r , o n l y
manufacturing outfits situated in
industrial areas will have their
Registration Certificate valid for 5
years while those located in
residents areas have one year
validity (yearly 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 a suspension of
f u r t h e r p r o c e s s i o n o f t h e
application.
REGISTRATION OF IMPORTED
PRODUCTS
* DRUGS: OTC Drugs =N=
1,000,000 (one million naira)
1268
Breakdown
=N= 10,000 permit to import
=N= 890,000 processing fees
=N= 100,000 registration certificate
Renewal is 60% of total cost of
registration
* ENTHICAL DRUGS =N=250,000
(Two hundred and fifty thousand
naira)
Breakdown
=N= 10,000 permit to import
=N= 140,000 processing fees
=N= 100,000 registration certificate
Renewal is 100% of total cost of
registration
* ORPHAN DRUGS =N=90,000
(Ninety thousand naira)
Breakdown
=N= 10,000 permit to import
=N= 80,000 processing fees
* FOOD =N=750,000 (Seven
hundred and fifty thousand naira)
Breakdown
=N= 10,000 permit to import
=N= 640,000 processing fees
=N= 100,000 registration certificate
Renewal is 60% of total cost of
registration
* COSMETICS =N=750,000 (Seven
hundred and fifty thousand naira)
Breakdown
=N= 10,000 permit to import
=N= 640,000 processing fees
=N= 100,000 registration certificate
Renewal is 60% of total cost of
registration
* M E D I C A L D E V I C E S :
=N=250,000 (Two hundred and
fifty thousand naira)
Breakdown
=N= 10,000 permit to import
=N= 140,000 processing fees
=N= 100,000 registration certificate
Renewal is 100% of total cost of
registration
* VACCINES/BIOLOGICALS
=N=150,000 (One hundred and
fifty thousand naira)
Breakdown
=N= 10,000 permit to import
=N= 40,000 processing fees
=N= 100,000 registration certificate
Renewal is 100% of total cost of
registration
* CHEM1CALS/PESTC1DES:
=N=200,000 (Two hundred
thousand naira)
Breakdown
=N= 10,000 permit to import
=N= 90,000 processing fees