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      A.General Requirements

1.        The manufacturing plant should be registered within the board’s registry, a copy should be attached.

2.        The pharmaceutical product with the same specifications should be registered and freely sold in the country of origin, and if not please give justifications.

3.        A copy of a valid local agent importation license should be submitted.

4.        A copy of the agency agreement from the Commercial Registration Department – Ministry of Justice should be submitted.

5.        The application form should be filled by the applicant (this form is available at the website of the NMPB).

6.        The registration dossier should be complete and include all the required correct documents in Arabic and/or English language.

7.        Samples should be submitted.

8.        The prescribed fees should be paid.

 

      B. Specific Requirements for Registration of Human Medicines

 The registration file submitted should be as it has been prepared by the manufacturer, as hard or soft copy, it could be in CTD or non CTD format and should include the following fundamental documentation:

The application form

  Two copies.

1.   Certificate of a Pharmaceutical Product (CPP)

      Original and issued by the competent authority in the country of origin authenticated and stamped by Sudan Ministry of Foreign Affairs, (it is preferred to be a WHO type Certificate or at least containing the same information).

2.   Marketing licensing or authorization in other countries

Provide a list of the countries in which this product has been granted license for marketing with copies of marketing authorizations in each of these countries.

 

3.   Composition formula

Provide complete composition and quantitative formula for the product issued from the manufacturer with the reference for it.

 

4.   Stability data

Provide the stability studies according to the WHO protocol (Climatic zone 4A) for the proposed shelf life. In case of any differences between the conditions of the provided stability studies and the required conditions for scientific reasons and specificity of the products, please provide the supporting scientific justification with the reference for it.

 

5.  Declaration from the manufacturer of the finished product that the product is free from alcohol for oral liquid products.

 

6.   Certificate stating that the product is free from (TSE / BSE) and a Halal Certificate if the source of the active, in-active and/or any other substance within the product is of animal origin.

7.   Bioequivalence Study for the targeted generic preparations (published on the website of the NMPB).

8.   Provide one sample of the product.

 

Secretariat General

National Medicines and Poisons Board