Cosmetics Registration in Sudan
Regulatory Authority:
National Medicines and Poisons Board (NMPB)
Link for RA:
Local regulation:
Pharmacy, Poisons, Cosmetics and Medical Devices Act
Who can register :
Data to be communicated :
The Applicant Should Submit the Following:
- Free Sale Certificate from Country of Origin (FSC):
This Certificate should be provided by the exporting country’s competent regulatory authority. It should include the product’s name, the manufacturer’s name and address, and a statement stating that the cosmetics items are freely sold in the country of origin.
The Sudan Ministry of Foreign Affairs should authenticate and stamp the FSC.
- Composition Formula:
Provide a comprehensive composition formula for the product’s active and inactive ingredients, the purpose of use for each, the CAS No. and the colour index (CI) for colourants.
- Inner and outside pack artwork, information leaflet (if applicable), and product photo
- Certificate of Analysis for the Finished Product:
Original Certificate of analysis displaying results of all physical, chemical, and microbiological testing and the product’s name, batch number, manufacturing, and expiry dates.
- Certificate of Analysis for the Active and Inactive Ingredients:
Original Certificate of analysis displaying results of all physical, chemical, and microbiological testing and the product’s name, batch number, manufacturing, and expiry dates.
- Manufacturing Method of the Finished Product:
Detailed manufacturing method.
Process:
General Requirements:
- The manufacturing plants should be listed in the National Manufacturing Plants Database (NMPB) (not required for listing cosmetics products).
- The applicant must complete the application form.
- A valid cosmetics manufacturing licence for national products is required of the applicant.
- The product must adhere to the Sudan legalisation annexes (on the NMPB website).
- Pork derivatives should not be present in the product.
- Alcohol should not be present in mouthwashes.
- All documentation must be written in either English or Arabic.
- If fees are mentioned, they should be paid.
Specific Requirements:
- In the country of origin, the cosmetic product should be freely sold (not required for national cosmetics products).
- The applicant must have an importation permit.
- Sudan Registrar of Companies, Ministry of Justice, has certified a copy of the agency agreement (not required for national cosmetics products).
Timeframe and fees:
Additional information:
The following information shall appear on the container and packaging of cosmetic products, in Arabic and English and should be indelible and readable:
- Name of the product.
- Name and address of the manufacturer or Marketing Authorization Holder.
- Country of origin.
- Manufacturing and expiry date of minimum durability.
- List of all ingredients.
- The batch number or reference for identifying the product.
- Nominal content (e.g. ml/mg).
- The product’s function (unless it is clear from the presentation).
- Precautions.
- Storage condition.