Guidelines for Registration of Imported Herbal & Cosmetic Products in Benin

General :
These Guidelines are for the interest of the general public and in particular, foreign manufactures / exporters and local importers of Food products in Benin. It is necessary to emphasize that, no Herbal & Cosmetic products shall be manufactured, imported, exported, advertised, sold, distributed or used in Benin unless it has been registered in accordance with the provisions of ABREP -2020, and other related Legislations and the accompanying Guidelines.

Application:
The Application for the registration of all imported Herbal & Cosmetic products shall be made by either the foreign manufacturer or the authorized foreign merchant exporter through ABREP accredited legal agent.

Step I

1.  

The ABREP accredited legal agent will guide the applicant on the necessary documents for product registration. After successful submission, the documents will be processed accordingly.

• A single application form shall be submitted for the product(s)
• The application letter addressed to the Director-General (ABREP),

      Attention: Director, Agence Béninoise de Régulation et

      d’Enregistrement des Produits (ABREP)

      Cotonou – Republique du Benin

2. Power of Attorney.

The accredited legal agent representing the applicant outside Benin or the applicant must file an evidence of Power of Attorney (POA) from the manufacturer or the authorized merchant exporter which authorizes the legal agent to speak for his Principal or the applicant speak for himself: on all matters relating to the product approval / registration.

• The Power of Attorney shall (be):

 Issued by the manufacturer, the authorized merchant exporter of the product authorizes, better still by applicant or the legal agent to speak for his Principal; on all matters relating to the latter’s specialties.

• The Power of Attorney shall (be):

 Signed by the Managing Director, General Manager, Chairman, President or Owner of the company or the Applicant Legal Agent stating the names of the product to be registered.

• The Power of Attorney shall also indicate ‘Authority to register the product with ABREP of the Ministry of Health Benin.
• The Power of Attorney must be notarized or legalized in the Tribunal de Commerce Benin.
• The Power of Attorney must be valid for at least 2 years (24 Months).

3. Certificate of Manufacture and Free Sale:

The manufacturer must show evidence that the company is licensed to manufacture Herbal & Cosmetic 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 of product
• Indicate the name and address of the manufacturer and product to be registered
• Copies of the above papers must be legalized in the Tribunal de Commerce Benin.

4. Product Labels/artwork:
5. Labeling of Herbal & Cosmetic products should be informative, accurate and in conformity with the ABREP Cosmetics Products Labeling Regulations and any other relevant Regulations

Labels of the products must include, but not limited to;

• Name / address of manufacturer
• Ingredients used
• Direction for Storage
• Date of manufacture
• Batch number
• Date of expiry or Best Before date

5. Comprehensive Certificate of Analysis.

The product 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 all relevant technical parameters of interest in addition to 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.

Step II

6. Submission of products for laboratory analysis

After successful vetting of products, laboratory samples are submitted. The following documents are included;

• Letter of submission of products for analysis
• Payment Receipt of applicable fee
• Certificate of analysis

Step I11

7. Product Approval Meeting:

A 3 member approval committee will review the product’s analysis report for approval.

11.  Issuance of Certificate of Product Registration:

After the Product Approval meeting, an electronic Certificate of Product Registration is issued to the Applicant.

8.  Tariff:

See ABREP Tariff section (Tariff)

9. Submission of products physical sample(s) for laboratory analysis

Sending of product physical sample is optional,but should be directly sent to the appropriate receiver for Quality Inspection, as authorized by ABREP,however,product analysis report remains top priority for the registration of product(s)

After successful submitting of product sample, the following documents are included;

• Letter of submission of products for analysis
• Payment Receipt of applicable fee
• Certificate of analysis

10.   Note:

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

• A successful application will be issued a Certificate of Product 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 ABREP shall be required if the product is to be advertised.
• For further information on advert approvals, see Guidelines for Regulated Products in Benin

 All correspondences should be addressed to:-

Director-General (ABREP),

Attn: The Director

Agence Béninoise de Régulation et

d’Enregistrement des Produits (ABREP)

Ministere de la Sante,

Cotonou, Republique du Benin.

Email: gouv-santebj@gouvsantebj.com