OMC Medical
OMC Medical

Cosmetics Registration in Sudan

Regulatory Authority:

National Medicines and Poisons Board (NMPB)

Link for RA:

http://nmpb.gov.sd

Local regulation:

Pharmacy, Poisons, Cosmetics and Medical Devices Act

Who can register :  

Data to be communicated : 

The Applicant Should Submit the Following:

  1. 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.

  1. 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.

  1. Inner and outside pack artwork, information leaflet (if applicable), and product photo    
  1. 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.

  1. 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. 

  1. 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.