The National Agency for Food and Drug Administration and Control has the responsibility of ensuring that all drug products placed on the Nigerian market for use meet the requirements for Quality, Safety and Efficacy throughout the lifecycle of the product.
The procedure for renewal of the license of all drug products outlines the process to be followed and the technical requirements to be met before a product can be continually placed on the Nigerian market.
A product authorized for marketing in Nigeria will be issued a Certificate of Registration valid for 5 years and should be continually renewed upon expiration.
These guidelines are intended to provide guidance on the technical and other general data requirements when applying for renewal of product license for all drug products.
The steps involved in certification renewals for human and veterinary drugs are thus itemized below:-
Step I
Application Letter for Renewal of Product Licence
– An application for renewal should be initiated not later than 30 calendar days to the date of expiration of the current/valid Licence.
-An application for the renewal of all drug products should be submitted and processed online.
-The renewal application should be addressed to the Director-General (NAFDAC).
-A separate application form should be submitted for each product.
Step II
Documentation
The following documents are the requirements for submission of an application for renewal of product license:-
Annual License/Premises Registration
-The current Annual Licence to practice and the Certificate of Retention of Premises for the
Superintendent Pharmacist issued by the Pharmacy Council of Nigeria (PCN) should be submitted.
Manufacturing Licence
-Issued by a relevant health/regulatory body in the country of manufacture (For products manufactured outside Nigeria).
– This license is to be authenticated by the Nigerian Embassy or High Commission in the country of origin. In countries where no Nigerian embassy exists, any Commonwealth or ECOWAS country can authenticate.
– It should also indicate the name and address of manufacturer and the products to be registered.
Certificate of Pharmaceutical Product (COPP-WHO Format)
– This is to be issued by a relevant health/regulatory body in the country of manufacturer (For products manufactured outside Nigeria).
– This certificate is also to be authenticated by the Nigerian Embassy or High Commission in the country of origin. In countries where no Nigerian embassy exists, any Commonwealth or ECOWAS country can authenticate. Indicate Name and address of manufacturer and the products to be registered.
Evidence of expired NAFDAC license
-A copy of the expired Certificate of Registration for the product (s).
Evidence of Registration of Brand Name/Trademark
– This should be done in the name of the owner of the Trademark/Brand name.
A Notarized Declaration
-A declaration by the applicant regarding the correctness, completeness and accuracy of all documents submitted should be provided.
-The format should be in line with the template attached as Annex 2 in this guideline. This document must be notarized by a notary public.
Power of Attorney/Contract Manufacturing Agreement (where applicable)
– At the expiration of a product license, the Power of Attorney or Contract Manufacturing Agreement may have lapsed except in cases when a specific expiration date was specified in the original power of attorney or contract manufacturing agreement or a statement that the power of attorney is for an indefinite period.
– Except in the cases stated above, an Applicant will be required to submit a new power of attorney or contract manufacturing agreement at renewal.
-The document shall give details of:
a). The Issuer and the Receiver of the Power of Attorney and in the case of a Contract Manufacturing Agreement, the parties involved with their specific roles and the terms of the contract agreement.
b). A list of the products covered by the Power of Attorney (this can come as an annexure for large number of products but must form part of the power of attorney with a specific reference to the annexure stated on the Power of Attorney).
c).State ownership of Brand name/s or Trademark.
d). The validity of the Power of Attorney should be stated, and it should not be less than 5 years.
e). The document must be signed by the authorized person(s) and should be notarized by a Notary Public in the country of manufacture.
f). A list of Approved Variations for the product (where applicable). This should Indicate the type of variations and respective dates of approval.
g). Product Quality Review (PQR) and current Quality Information Summary (QIS)
Step III.
Good Manufacturing Practice (GMP)
-For Information on the Inspection of manufacturing facility, Applicant should visit the Drug Evaluation and Research (DER) Directorate section of NAFDAC.
– The GMP status of the manufacturing facility will be considered before the renewal of the product license is issued.
Step IV
Issuance of Notice of Renewal
– Upon satisfactory review of submitted documents and satisfactory GMP, a Notice of Renewal (NOR) shall be issued.
Step V
Submission of laboratory samples:
-For Imported products, samples for laboratory analysis should be submitted while samples will be drawn for locally manufactured products during the GMP Inspection.
-The following documents are required:-
a). Letter for submission of laboratory samples.
b). Evidence of payment of processing fee
c).Certificate of analysis :-
The Certificate of Analysis must be presented on a letter-head of the quality control laboratory where the sample was tested/evaluated and should contain the under-listed information:
(i).The brand name of the product
(ii).The batch number of the product
(III). The manufacturing and expiry dates
(iv).The name, designation, and signature of the Analyst
(v). A copy of Notice of Renewal
Step VI
Product Approval meeting
-Upon meeting all regulatory requirements, product is presented for Approval Meeting.
Step VII
Issuance of Certificate
-For products approved at the meeting, an electronic certificate of Renewal of Product Registration is issued to the applicant.
Product Label
– The product label at renewal should be the same as first approval unless an approval for a change in Labelling was gotten.
–Tariff :- Tariff information is to be procured on direct checks with NAFDAC
It should be noted that :-
– A failure to comply with these requirements may result in the disqualification of the renewal application or lead to considerable delay in the renewal process.
-A successful renewal application will be issued a Certificate of Registration with a validity period of another five (5) years.
– The renewal of 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. Simultaneous submission of renewal and advertisement applications are not allowed.
– NAFDAC reserves the right to revoke, suspend or vary a certificate during its validity period.
– Filing an application form or paying an application fee does not confer renewal of license status.
-Failure to respond promptly to queries or enquiries raised by NAFDAC on the renewal application (within 45 working days) will automatically lead to the closure of the Application.
-The timeline for Renewal of Certificate of Product Registration from acceptance of submissions to issuance of Registration number is ninety (90) working days.
– Please note that the clock stops once compliances are issued.
