DIRECTORATE OF REGISTRATION AND REGULATORY AFFAIRS
GUIDELINES FOR CHANGE OF MANUFACTURER’S REPRESENTATIVE
FOR REGISTERED IMPORTED REGULATED PRODUCTS
1. These guidelines are for the interest of the general public and in particular, industries in Nigeria that have registered imported regulated products.
2. It is necessary to emphasize that, no regulated product shall be manufactured, imported, exported, advertised, sold or distributed in Nigeria unless it has been registered in accordance with the provisions of Act Cap F33 LFN (formerly
decree 19 of 1993) and the accompanying guidelines.
3. These guidelines are intended for manufacturers with representative companies in Nigeria with whom their products have been registered but may decide to change such representative.
4. The NAFDAC Registration certificate of the product(s) should be valid at the time of transfer and must be sourced from the same registered source.
5. Change of manufacturer’s representative at renewal will be treated as a renewal process.
6. The new representative in Nigeria, whether a corporate body or an individual with the new Power of Attorney will be held responsible for ensuring that the competent authority in the country is informed of any serious hazard newly associated with the 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, counterfeited or sub-standard products.
1. An application for change of representative and transfer of product certificate should be made by the manufacturer to the Director General with the following documents
(i) Letter of Notification from manufacturer to NAFDAC informing on revocation of former power of attorney and introduction of the new representative.
(ii) Power of Attorney issued to new agent which should be:
(a) Notarized by a Notary public in the country of manufacture.
(b) Issued by the manufacturer of the product.
(c) Signed by the responsible officer of the Company.
(iii) Copy of notarized Revocation of Power of Attorney to the former representative copying the new agent/representative and NAFDAC.
(iv) Certificate of Registration of Brand Name with the trademark Registry in the Ministry of Commerce in Nigeria which should be in the name of the Manufacturer.
(v) Certificate of Business Incorporation of the company from the Corporate Affairs Commission in Nigeria. (except for drug applications)
(vi) Current Annual Licence to Practice of the Superintendent Pharmacist issued by the Pharmacists Council of Nigeria. (Drug applications only)
(vii) Current Certificate of Registration/Retention of Premises issued by the Pharmacists Council of Nigeria. (Drug applications only)
(viii) Copy of product registration certificate.
All fees to the Agency shall be in bank draft in favour of National Agency for Food and Drug Administration and Control.
OTC drugs: N 500,000:00 + 5% VAT
Ethical drugs: N 125,000:00 + 5% VAT
Medical devices: N 125,000:00 + 5% VAT
Cosmetics: N 375,000:00 + 5% VAT
Vaccines and Biologicals: N 75,000:00 + 5% VAT
Veterinary drugs: N 125,000:00 + 5% VAT
Pesticides: N 100,000:00 + 5% VAT
Herbal products: N 137,500:00 + 5% VAT
Nutraceuticals and food supplements: N 375,000:00 + 5% VAT
Food: N 375,000:00 + 5% VAT
(i) Transfer must be completed before importation, advertisement, distribution could be made.
(ii) NAFDAC reserves the right to revoke, suspend or vary the certificate during its validity period.
(iii) Failure to respond promptly to queries on enquiries raised by NAFDAC on the application, may lead to suspension of further processing of the application.
(iv) All documents must be found satisfactory before any payment is made.
All correspondence in respect of the above application should be addressed to The Director, Registration and Regulatory Affairs, National Agency for Food & Drug Administration & Control, Lagos.
E-mail address: email@example.com
Telephone number: 1-4772452, 01-4748627