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Rwanda Cosmetic Product Registration

COSMETIC REGISTRATION IN RWANDA

Regulatory Authority

Rwanda food and Drug authority

Link for Regulatory Authority

https://rwandafda.gov.rw/.

Local Regulation

Rwanda FDA law No 003/2018 of 09/02/2018, Article 8)

Who can Register?

Process to Register Cosmetic Product

Application for registration of medicated cosmetics: To introduce medicated cosmetics to the Rwanda market, they must first be registered with the authority, as per the regulations outlined herein. Any individual or entity intending to manufacture, import, or export such products must apply for registration of medicated cosmetics to the Authority. 

This application should be made in writing and can be submitted by either the Marketing Authorization Holder, the manufacturer, or the local technical representative.

Application Requirement for Registration of Medicated Cosmetics

  • Requests for the registration of medicated cosmetics must be submitted both in hard copy and electronically, following the specifications outlined in the guidelines titled “Submission Documentation Guidelines for Registration of Medicated Cosmetics No. DHT/GGL/023.”
  • Each medicated cosmetic with distinct ingredients, formulation, intended use, forms, or site of manufacture requires a separate and comprehensive registration application.
  • A distinct and complete registration application is necessary for products sharing the same ingredients and formulation but differing in colour and/or fragrance.
  • Unless otherwise specified in these Regulations, it is prohibited to manufacture, sell, supply, import, export, or administer any product without proper registration and the requisite license issued under these Regulations.
  • All medicated cosmetics manufactured, imported, exported, distributed, sold, and used in Rwanda must adhere to packaging and labelling requirements outlined in this regulation.
  • Registration shall be denied for products containing substances prohibited or suspended from use in Rwanda or listed as banned or suspended in international conventions ratified by Rwanda.

The authority is responsible for publishing a list of prohibited, restricted, suspended, and banned ingredients permissible for use in medicated cosmetics.

Timeframe and Fees

Additional Information

A certificate of full registration granted pursuant to Article 16 shall remain valid for a duration of five (5) years from the issuance date, unless suspended or revoked prior to expiration. Renewal of the certificate is possible upon payment of the prescribed annual retention fees.

Renewal of a Registration

Application for the renewal of a registration certificate must be submitted to the Authority at least ninety (90) calendar days prior to its expiration. A grace period of ninety (90) days after the designated expiry date will be provided for renewal. Failure to renew within this grace period will result in the application being treated as new. The application must adhere to the prescribed format outlined in the Rwanda FDA guidance for the renewal of medicated cosmetics.

Additional Information 

Packaging materials must be composed of substances or materials that are safe and suitable for their intended purpose, ensuring the product is housed in containers capable of maintaining its safety and quality. Cosmetic labels must provide informative, accurate, prominent, distinct, and legible information, maintaining these qualities throughout the normal conditions of sale and use during the cosmetic’s useful life. 

Labelling must be presented in at least one of the official languages used in Rwanda and comply with the International Nomenclature of Cosmetic Ingredients (INCI) for ingredient listing. Cosmetic products must not be described or presented in a deceptive, false, misleading, or potentially confusing manner regarding their nature, quality, quantity, or origin. 

The outer packaging, immediate container, or accompanying leaflet of all medicated cosmetic products must include the following information:

  • Brand name (if applicable)
  • Product name
  • Manufacturer’s name and physical address
  • Marketing authorization holder (if applicable)
  • Lot or batch number
  • Manufacturing date
  • Expiry date
  • Net content (weight/volume)
  • List of ingredients (INCI name)
  • Function of the cosmetic product
  • Instructions for use
  • Country of origin
  • Storage conditions
  • Warnings and precautions