Law in details

Traditional Medicine Practice Act, 2000 (Act 575)

Section 22: The Board may revoke, suspend or refuse to renew a licence of a practice where the Board is satisfiedthat(a) the provisions of this Act are not being satisfactorily complied with,(b) the continued operation of the practice creates risk to public health, safety or is indecent,(c) the services provided in the practice have deteriorated below the required standard,(d) qualified practitioners have not been employed by the owner or operator of the practice,(e) a practitioner in the practice is not a fit or qualified person to be so employed,(f) there is a breach of quality control requirements in the preparation of the herbal medicinedispensed by the practice, or(g) there has been a breach of any of the provisions of sections 11 to 26 of the Food and DrugAct, 1992.2(2)

Procedures 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

Legon, Accra
Email:info@fda.gov.gh
Website:https://www.fdaghana.gov.gh/

Relevant Forms to Download

Not Available

Fees / Charges




Not Avaiable