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                                                                              Requirements for Registration of foreign manufacturers

 

        i.          Requirements for registration of Medicines manufacturers:

1.       A cover letter from the local agent.

2.       Registration form of foreign company available in the website of NMPB.

3.       Original agency agreement authenticated by the registrar of companies.

4.       A valid copy of manufacturing license issued by the health authority in the country of origin.

5.        Original valid GMP certificate from the competent authority in the country of origin authenticated by the Ministry Of Foreign Affairs, Sudan.

6.       Provision of the Site Master File (SMF) containing all necessary information.

       ii.          Requirements for registration of Cosmetics manufacturers:

1.       A cover letter from the local agent.

2.       Registration form of foreign company available in the website of NMPB.

3.       Original agency agreement authenticated by the registrar of companies.

4.       A valid copy of manufacturing license issued by the competent authority in the country of origin.

5.       Original Free sale certificate issued by the regulatory authority in the country of origin authenticated by the MOFA-Sudan (Ministry of Foreign affairs).

6.       Original valid GMP certificate from the competent authority in the country of origin authenticated by the Ministry of Foreign Affairs, Sudan, or quality certificate (ISO 22716).

7.       Provision of the Site Master File (SMF) containing all necessary information.

 

     iii.          Requirements for registration of Medical devices and Consumables:

1.      A cover letter from the local agent.

2.      Registration form of foreign company available in the website of NMPB.

3.      Original agency agreement authenticated by the registrar of companies.

4.      A valid copy of manufacturing license issued by the competent authority in the country of origin.

5.      Original valid GMP certificate from the competent authority in the country of origin authenticated by the Ministry of Foreign Affairs, Sudan, or quality certificate (ISO 13485).

 

     iv.          Requirements for registration of Food supplements and health products:

1.      A cover letter from the local agent.

2.      Registration form of foreign company available in the website of NMPB.

3.      Original agency agreement authenticated by the registrar of companies.

4.      A valid copy of manufacturing license issued by the competent authority in the country of origin.

5.      Original valid GMP certificate from the competent authority in the country of origin authenticated by the Ministry of Foreign Affairs, Sudan, or quality certificate (ISO 22000) or HACCP certificate.

6.      Provision of the Site Master File (SMF) containing all necessary information.

 

Secretariat General

National Medicines and Poisons Board