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HEALTH PROFESSIONS REGULATORY BODIES ACT, 2013 (ACT 857)

Section 16: A registration shall not be cancelled or suspended unless the Board has given the practitioner at least thirty days notice of its intention to suspend or cancel the registration and has provided the practitioner annopportunity to make representations to the Board.






Subject : Registration (Traditional medicine)  

Procedure to Follow


Registration
1. An application for the registration of Herbal medicinal product shall be made in writing.
2. An application form shall be completed in accordance with the sequence of appendices dated, signed and stamped by the applicant/license holder.
3. This shall be submitted in duplicate (hard and (or) soft copy) and accompanied by:
a.  A covering letter addressed to the CEO of the Authority,
b. Samples of the product as specified in the Authority’s samples Schedule, packed in the final package ready for sale.
c.  A non-refundable fee prescribed in the Authority’s approved fees Schedule.
Registration Variation
1. An application for the variation of registration of a product prior to re-registration shall be made to the Authority. This variation shall be approved by the Authority before any importation of the product shall be made into the country.
2. The application shall be accompanied by:
a. Supporting documentation for the variation.
b. Samples reflecting the variation as specified in the Authority’s samples Schedule.
c. Non-refundable variation fee as specified in Authority’s approved fees Schedule.
Re-Registration
1. An application for the re-registration of Herbal medicinal product should be made 3 (three) months before the expiration of the registration. 2. The application shall be accompanied by:
a.  Supporting documentation for any changes since the product was last registered
b. Samples as specified in the Authority’s Sample Schedule.
c. A non-refundable application fee as specified in the Authority’s Fee Schedule....
Responsible Institution


Food And Drugs Authority

No. 17 Indian Ocean Street, Nelson Mandela Avenue, Shiashie

Relevant Forms to Download

Not Available

Online System

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Fees/ charges

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