Law in details

Traditional Medicine Practice Act, 2000 (Act 575)

Section 18: (1) A person may apply to the Council for a licence for a practice through the district office of theCouncil within the area in which the practice is to be operated in the form determined by the Board.(2) There shall be attached to the application,(a) the block plan of the premises for the practice,(b) provisional approval from the district planning authority or relevant authority on land use,(c) evidence of ability of proposed practitioners in the practice and proof of their registration,(d) testimonials of each proposed practitioner in the proposed practice from the Association,(e) two passport size photographs of each proposed practitioner in the practice,(f) a list of the types of services to be rendered by the practice, and(g) the prescribed licensing fee.(3) A licence shall not be granted to an applicant unless the Board is satisfied that the applicant(a) is registered as a practitioner under this Act,(b) has the experience and competence to manage the practice in accordance with this Act, and(c) has complied with any other requirement specified by the Board and any other relevant law.(4) The Board may request from the applicant where necessary(a) clearance or an appropriate permit from the Environmental Protection Agency, and(b) evidence of financial viability for the ownership and operation of the practice.19. Issue and renewal of licence(1) Where the Board is satisfied that an applicant has fulfilled the conditions required under this Actfor licensing of a practice, it shall approve the application and issue the applicant with a licence.(2) The licence shall expire on the 31st day of December of each year and may be renewed subject tothis Act.(3) The applicant shall pay, in respect of the licence or a renewal of the licence, the prescribed fee anda licence or renewal shall not be issued or made unless the prescribed fee has been paid.

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