Imported-NAFDAC Registration

PRODUCT REGISTRATION WITH NAFDAC

It is necessary to emphasize that, no drug/veterinary drugs/ herbal/food&cosmetics shall be manufactured, imported, exported, advertised, sold distributed or used in Nigeria unless it has been registered in accordance with the provisions of NAFDAC Act CAP N1 (LFN) 2004,

PRODUCT REGISTRATION FLOW

Step I

 An written application for registration of imported drug/food/cosmetics should be made on the company’s letter
head paper to the Director-General (NAFDAC), ATTENTION: The Director, Registration &
Regulatory Affairs (R & R) Directorate, Ground Floor, NAFDAC Office Complex, Isolo Industrial
Estate, Oshodi-Apapa Express Way, Isolo, and Lagos State.
Ø  The application letter should include the generic name of product and brand name (where
applicable).
Ø  An online application form for Product Registration should be purchased at;
http://registration.nafdac.gov.ng and completed.
Ø  A separate application form should be submitted for each product.
 

Step II

Import Permit and Label vetting
Ø  Upon successful screening of documentation and review of supporting documents, an Import
Permit shall be issued after which products are submitted for vetting.
 

STEP III

Submission of samples for laboratory analysis
After successful vetting of product labels, laboratory samples are submitted. The following
documents are included;
Ø  Evidence of payment to the Agency
Ø  Certificate of analysis.
Ø  Evidence of submission for vetting.

Step IV

Product Approval meeting
Ø  Upon satisfactory Dossier(drug) review, satisfactory GMP of the production facility and satisfactory
laboratory analysis of product, products are presented for Approval Meetings.
Ø  For products labels with compliance issues, compliant artworks may be submitted with a
commitment letter from the manufacturer (stating that the commercial products will be in
compliance).

Step V

Ø  Issuance of certificate
Ø  For products approved at the meeting, Notification of Registration or Listing is issued to the
applicant while compliance directive is issued to those not approved.

Labelling Guidelines for Imported Drugs
Visit http://registration.nafdac.gov.ng for more details

Timeline

Submission of application – 0 days
Document verification – 10 days
Facility inspection/sampling – 10 days for food, 20 days for drugs
Laboratory analysis – 30 days for food, 40 days for drugs
Final vetting – 10 days
Approval meeting/issuance of NAFDAC registration number(certificate of registration) – 20 days
Total number of days: 90 days for food, 120 days for drugs

For Imported Food & Cosmetics

Required documents

  • CAC certificate
  • Notarized Declaration
  • Power of Attorney or Contract Manufacturing Agreement
  • Contract Manufacturing Agreement
  • Certificate of Manufacture and Free Sale
  • Comprehensive Certificate of Analysis
  • Evidence of Registration of Brand Name with Trademark Registry in the Ministry of Industry
  • Label or artwork of the product
  • Letter of Invitation for Good Manufacturing Practice (GMP) inspection

Detailed Explanation

  1. Evidence of Business Incorporation of the importing company with the Corporate Affairs Commission in Nigeria.
  2.  Notarized Declaration to be completed (typed), signed by Declarant and notarized by a Notary Public in Nigeria.
  3.  Power of Attorney or Contract Manufacturing Agreement. An applicant on behalf of a manufacturer outside Nigeria must file evidence of Power of Attorney from the manufacturer which authorizes him to speak for his principal, on all matters relating to the latter’s specialties. The Power of Attorney shall (be):
    • Issued by the manufacturer of the product.
    • Signed by the Managing Director, General Manager, Chairman or President of the company, stating the names of the products to be registered. The power of attorney shall also indicate ‘Authority to register product with NAFDAC
    • State ownership of Brand name(s)/Trademark.
    • Notarized by a Notary Public in the country of manufacture.
    • Valid for at least five (5) years.
  4. Contract Manufacturing Agreement: An applicant filing an application on behalf of his company, and being the owner of the product, shall provide a Contract Manufacturing Agreement, which shall be signed by himself (or his competent representative) and the manufacturer. The Agreement shall be
    • Notarized by a Notary Public in the country of manufacture.
    • Signed by both parties stating names and designations of the signatories with the names of all the products to be registered and other relevant clauses clearly explained in an unambiguous language.
  5. Certificate of Manufacture and Free Sale. The manufacturer must show evidence that the company is licensed to manufacture cosmetics products and that the sale of the product does not constitute a contravention of the laws of that country, i.e., Free Sale Certificate (Certificate of Manufacture and Free Sale). The Free Sale Certificate should:
    • Be issued by a relevant Health/Regulatory body in the country of manufacture.
    • Indicate the name of manufacturer and products to be registered.
    • 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 the document.
  6. Comprehensive Certificate of Analysis. The certificate of analysis must be presented on a letter-headed paper of the Quality Control Laboratory where the sample was tested/evaluated and should contain the under listed information:
    • The brand name of the product
    • The batch number of the product
    • The manufacturing and expiry dates
    • The name, designation and signature of the analyst.
  7. Evidence of Registration of Brand Name with Trademark Registry in the Ministry of Industry, Trade and Investment. This should be done in the name of the owner of
  8.  Label or artwork of the product
  9.  Letter of Invitation for Good Manufacturing Practice (GMP) inspection: A letter of invitation to inspect the factory abroad shall be written by the manufacturer and shall state the following:
    • MANUFACTURER INFORMATION: Name of Company, full location address of factory (not administrative office address), e-mail, and current phone number. Details (name, phone number and email) of contact person overseas.
    • LOCAL AGENT INFORMATION: Name of company, full location address, functional phone no., e-mail address. Details (name, phone number and email) of contact person. Names(s) of product(s) for registration

FOR IMPORTED HUMAN AND VETERINARY DRUGS

Required Documents

Ø  Notarized Declaration
Ø  Power of Attorney or Contract Manufacturing Agreement
Ø  Contract Manufacturer Agreement
Ø  Evidence of Business Incorporation (CAC)
Ø  Manufacturing License/Certificate of Free Sale
Ø  Certificate of Pharmaceutical Product (COPP-WHO Format)
Ø  Current Good Manufacturing Practice (cGMP) of the manufacturing facility.
Ø  Reference the Manufacturer’s License Nos Form 25 and Form 28
Ø  CTD Dossiers
Ø  Evidence of valid Premises Retention License for the facility.
Ø  Comprehensive Certificate of Analysis for product(s)
Ø  The Certificate of Analysis for finish product
Ø  Label or artwork of the product
Ø  Letter of Invitation for Good Manufacturing Practice (GMP) Inspection

DETAILED EXPLANATION

Documentation

1.     Notarized Declaration (Appendix I). To be completed (typed), signed by Declarant and
notarized by a Notary Public in Nigeria.
2.     Power of Attorney or Contract Manufacturing Agreement. An applicant on behalf of a
manufacturer outside Nigeria must file evidence of Power of Attorney from the
manufacturer which authorizes him to speak for his principal, on all matters relating to the
latter’s specialties. The Power of Attorney shall be:
Ø  Issued by the manufacturer of the product.
Ø  Signed by the Managing Director, General Manager, Chairman or President of
the Company, stating the names of the products to be registered. The Power
of Attorney shall also state ‘Authority to register product with NAFDAC’.
Ø  State ownership of Brand name(s)/Trademark.
Ø  Notarized by a Notary Public in the Country of manufacture.
Ø  Valid for at least five (5) years.
3.     Contract Manufacturer Agreement. An applicant filing an application on behalf of his
company, and being the owner of the product, shall provide a Contract Manufacturing
Agreement. The Agreement shall be:
Ø  Notarized by a Notary Public in the country of manufacture.
Ø  Signed by both parties stating names and designations of the signatories
with the names of all the products to be registered and other relevant
clauses clearly explained in an unambiguous language.
4.     Evidence of Business Incorporation of the importing Company with Corporate Affairs
Commission in Nigeria.
5.     Manufacturing License/Certificate of Free Sale
Evidence that they are licensed to manufacture drugs for sale in the country of origin
(Manufacturer’s Certificate). The license shall be issued by a relevant Health/Regulatory
body in the country of manufacture.
6.  Certificate of Pharmaceutical Product (COPP-WHO Format)
Ø  There must be evidence by the competent Health Authority, that the sale of the product
does not constitute a contravention of the drug laws of that country. The Certificate of
Pharmaceutical Product (COPP) should;
Ø  Conform to WHO format.
Ø  Be issued by the relevant Health/Regulatory body.
Ø  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 the COPP.
7.  Current Good Manufacturing Practice (cGMP) of the manufacturing facility. This is to be:
Ø  Valid at the time of submission.
Ø  Be issued by the relevant Health/Regulatory body.
Ø  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 the document.
8.     Reference the Manufacturer’s License Nos Form 25 and Form 28
9.  Dossiers should be In a Compact Disc (CD).
Ø  Searchable Portable Document Format (pdf).
Ø  Common Technical Document (CTD) format
10.  Evidence of Registration of Brand Name with Trademark Registry in the Ministry of
Industry, Trade and Investment. This should be registered in the name of the owner of
the Trademark/Brand name as the case may be (Trademark Class 5 for Drugs).
11.  Copy of valid Annual License to practice for the Superintendent Pharmacist issued by
Pharmacists Council of Nigeria.
12.  Evidence of valid Premises Retention License for the facility.
13.  Comprehensive Certificate of Analysis for product(s)
14.  The Certificate of Analysis must be presented on a letter-headed paper of the quality
control laboratory where the sample was tested/evaluated and should contain the under
listed information:
Ø  The brand name of the product
Ø  The batch number of the product
Ø  The manufacturing and expiry dates
Ø  The name, designation and signature of the analyst
15.  Label or artwork of the product
16.  Letter of Invitation for Good Manufacturing Practice (GMP) Inspection: A letter of
invitation to inspect the factory abroad shall be written by the manufacturer and shall
state the following:
Ø  MANUFACTURER INFORMATION: Name of Company, full location address of
factory (not administrative office address), e-mail, and current phone no.
Details (name, phone number and email) of contact person overseas.
Ø  LOCAL AGENT INFORMATION: Name of company, full location address,
functional phone no., e-mail address. Details (name, phone number and
email) of contact person. Names(s) of product(s) for registration.