Application Process

Applications for the registration of imported Vaccine products must be submitted by the foreign manufacturer or an authorized foreign merchant exporter through a legal agent accredited by the Ministère de l’enregistrement des produits et de l’autorisation du commerce du Bénin (MOHBENIN).

A separate application is required for each individual product.

Required Documentation and Procedural Steps

The accredited legal agent will assist the applicant in preparing and submitting the necessary documentation. Upon successful submission, the documents undergo thorough processing and review.

1. Application Letter

Addressed to the Director-General of MOHBENIN, with attention to the Director, Ministère de l’enregistrement des produits et de l’autorisation
du commerce du Bénin (MOHBENIN), Cotonou, Republic of Benin.

2. Power of Attorney (POA)

The accredited legal agent must provide notarized evidence of a Power of Attorney from the manufacturer or authorized exporter. This document authorizes the agent to represent the principal in all matters related to product registration.

• It must be issued and signed by a senior executive (e.g., Managing Director, General Manager, Chairman, President, or Owner).
• It shall specify the product names and explicitly grant authority for registration with MOHBENIN under the Ministry of Health of Benin.
• The POA must be notarized or legalized at the Tribunal de Commerce in Benin and remain valid for a minimum of two years (24 months).

3. Contract Manufacturing Agreement

(if applicable) Where the applicant owns the brand name or trademark but is not the manufacturer, a formalized Contract Manufacturing Agreement must be submitted, signed by both parties.

• It must clearly list the products, include designations of signatories, and use unambiguous language.
• The agreement shall be legalized at the Tribunal de Commerce in Benin.

4. Certificate of Manufacture and Free Sale Issued by the relevant health or regulatory authority in the country of origin, confirming that the manufacturer is licensed to produce Vaccine products and that their sale complies with local laws.
   • It must include the manufacturer’s name, address, and details of the product.
   • Copies must be legalized at the Tribunal de Commerce in Benin.
5. Product Labels/Artwork

Labels must be informative, accurate, and fully compliant with MOHBENIN Vaccine Products Labelling Regulations. Essential elements include:

• Manufacturer’s name and address
• List of ingredients with quantities
• Storage instructions
• Manufacturing date
• Batch number
• Expiry date or “Best Before” date

6. Letter of Invitation for Good Manufacturing Practice (GMP) Inspection Issued by the manufacturer, inviting MOHBENIN to inspect the overseas production facility. The letter must detail:
   • Manufacturer’s company name, full factory address (not administrative office), email, phone number, and contact person details.
   • Local importer’s company name, address, phone number, email, and contact person details in Benin.
   • Full list of brand names and products submitted for registration.
7. Comprehensive Certificate of Analysis Issued on the letterhead of the testing laboratory, including:
   • Brand name, batch number, manufacturing and expiry dates
   • All relevant technical parameters
   • Name, designation, and signature of the analyst

Subsequent Stages

8. Import Permit and Laboratory Analysis

Following satisfactory document screening, an electronic import permit is issued, allowing product submission for laboratory testing (where required).

9. Submission for Laboratory Analysis

Accompanied by a submission letter, proof of fee payment, and the Certificate of Analysis.

10. Product Approval Committee Review A dedicated three-member committee evaluates the analysis results.
11. Issuance of Registration Certificate Upon approval, an electronic Certificate of Product Registration is issued, valid for five (5) years.
12. Tariffs Please refer to the official MOHBENIN Tariff section for applicable fees.

Important Notes

• Non-compliance with these requirements may result in application rejection or significant processing delays.
• Product registration does not include authorization for advertising; a separate application and approval from MOHBENIN are required.
• For details on advertising approvals, consult the Guidelines for Regulated Products in Benin.

All correspondence should be directed to:
Director-General, MOHBENIN

Attention: The Director
Ministère de l’enregistrement des produits et de l’autorisation
du commerce du Bénin (MOHBENIN), Ministry of Health Cotonou,
Republic of Benin