DIRECTORATE OF REGISTRATION AND REGULATORY AFFAIRS
GUIDELINES FOR REGISTRATION OF IMPORTED COSMETICS IN
NIGERIA.

NAFDAC/RR/001/00

A. GENERAL

1. These guidelines are for the interest of the general public, and in particular, cosmetics manufacturers and importers in Nigeria.

2. It is necessary to emphasize that no cosmetics products shall be manufactured, imported, exported, advertised, sold or distributed in Nigeria unless it has been registered in accordance with provisions of ACT CAP F33 LFN 2004 (Formerly decree 19 of 1993)

B. APPLICATION

1. (a) An application for the registration of a cosmetic product should be made by the manufacturer.

(b) In case of a manufacturer outside Nigeria, such should be represented in Nigeria by a duly registered company or individual with facilities to effect a recall of the product when necessary.

(c) An applicant for 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 original Power of Attorney is to be notarized by a Notary Public in the country of origin and submitted to NAFDAC.

Or

Contract Manufacturing Agreement:

a. Notarized by a notary public in the country of manufacture.

b. Should be 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

NOTE:

The representative in Nigeria, whether a corporate body or an individual with the Power of Attorney, will be responsible for ensuring that the competent authority in the country is informed of any serious hazard newly associated with a product imported under the provisions of the Act or of any criminal abuse of the certificate in particular, to the importation of falsely labeled, spurious, corrosive, or sub-standard cosmetic products.

2(a) The applicant must submit to the Registration Division, NAFDAC, a written application, stating the name of the manufacturer, name of the product, brand name (where applicable), and obtain the prescribed application form which must be properly filled, with all information required. This form shall be obtained on payment of the prescribed fee per product.

(b) A separate application form shall be submitted for each product

C DOCUMENTATION

1 The manufacturer, in the case of imported product, must show evidence that the company is licensed to manufacture and that the sale of the Product does not constitute a contravention of the Laws that country i.e Free Sale Certificate (Certificate of Manufacturer and Free Sale). Such evidence must be issued by the competent Authority in the country of manufacture, and should be authenticated by the Nigerian Mission in that Country. In countries where no Nigerian Embassy or High Commission exists, any other Embassy or High Commission of any Commonwealth or West African country can authenticate.

2 Comprehensive Certificate of analysis

3 Certificate of Business Incorporation with the corporate affairs commission in Nigeria

4 Certificate of Registration of Brand Name with trademark Registry (where necessary)

5 Applicants shall submit a letter of Invitation to inspect the factory abroad. They shall state the full location address of the manufacturer, Name of contact person, e-mail address, current phone no. & fax no., guide map illustrating the shortest land / air route to the factory.

6 A permit should be issued if documentation is satisfactory.

D LABELING

1. Labeling should be informative and accurate. In addition to the requirements of the regulations on labeling, the following minimum requirements must appear on the label.

(a) Name of Product – Brand Name (where applicable), must appear in bold letters.

(b) The name and full location address of the manufacturer, packer, distributor, importer, exporter or vendor of a cosmetic should be stated on both the inner and outer labels (where necessary) in such a manner that is easily readable.

(c) Batch number, Date of Manufacture (where applicable) and Best Before/Expiry Date.

(d) Net contents of essential ingredients in metric units.

(e) The ingredients must be listed by their common names in order of their predominance by weight.

(f) The label must contain directions for safe use (where appropriate) on the information panel (IP) or on the package insert (PI).

(g) Any regulated 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).

(h) Provision shall be made for NAFDAC Registration Number.

E TARIFF

All payments to the Agency should be in bank draft payable to National Agency for Food and Drug Administration and Control.

1 Application Form per product =N=250:00

2 Per Cosmetic product =N=750,000:00 plus 5% VAT

NOTE:

1 Mercury and its compounds and corticosteroids are not permitted in cosmetic products.

2 Lanolin and Boric Acid are not permitted in baby products.

3 Failure to comply with these requirements may result in the disqualification of the application or lead to considerable delay in processing of registration.

4 A successful applicant will be issued a Certificate of Registration with a validity period of five (5) years.

5 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.

6 NAFDAC may withdraw the Certificate of Registration in the event that the product is advertised without express approval from the Agency.

7 NAFDAC reserves the right to revoke, suspend or vary the certificate during its validity period.

8 Filling an application form or paying for an application fee does not confer registration status.

9 The time line for product registration from submission of samples up to issuance of registration number is eighty (60) work days. However, this depends on satisfactory compliance by the applicant.

All correspondence in respect of Product Registration should be addressed to:

Director,

Registration and Regulatory Affairs Directorate.

Central Laboratory Complex,

Oshodi, Lagos.

Website: www.nafdac.gov.ng

E-mail: registration@nafdac.gov.ng

Telephone numbers: 01- 4772452, 4728627

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