Ghana - Get Permit for Herbal Products

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Procedure

Apply In-Person:

1. To Get Permit for Herbal Products in Ghana, the applicant should contact the Foods and Drugs Authority (FDA) office Contact link
2. Applicant must obtain the application form for Herbal Products.
3. These forms must be filled with the necessary details and submitted to the FDA office.
4. The applicant has to make sure he or she has all the required documents that are required for this process to be successful and they can be found under the "Required Documents" section of this page.
5. Payment of appropriate fees should be made and that can be found under the "Fees" section of this page.
6. An application for the registration of Herbal medicinal product shall be made in writing.
7. An application form shall be completed in accordance with the sequence of appendices dated, signed and stamped by the applicant/license holder.
8. All certificates accompanying registration documents shall be submitted in English.
9. The cover letter submitted with the dossier should include a clear statement by the applicant indicating that the information submitted is true and correct.
10. If the applicant is a foreign company, it shall appoint a local agent through whom an application shall be submitted.
11. The local agent shall be a registered pharmaceutical wholesale company or an accredited manufacturer's representative in Ghana.
12. The application should be submitted through the authorized local agent by the regulatory contact person to the Ghana postal address.
13. If you are new applicant, this is an application for registration of a medicinal product that is intended to be placed on the Ghanaian market for the first time.
14. A new application may only be made by the applicant and he/she shall be the person who signs the declaration portion of FDA application form as per module 1.
15. A separate application is required for each product. Products that differ in active ingredient(s), strength, dosage forms, proprietary names though containing the same ingredients, are considered to be different products and hence require separate applications.
16. The registration of any food or drugs/medicinal products product with the FDA is a very slow process and can take between one or two months to be completed from the date samples are submitted for laboratory tests.
17. Applications awaiting additional samples expire after three (3) months from the date of submission of application.
18. A new application will be processed within 6 months of receipt of the application. The applicant will be required to provide any requested additional data within 12 months. In case additional time is required, a formal request must be submitted to the FDA.
19. After verification in the laboratory, if the applicant's documents are correct, the permit will be granted by the FDA.

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Required Documents

Please attach a copy each of the following documents:

• Supporting documentation for the variation.
• Samples reflecting the variation as specified in the Authority’s samples Schedule.
• This shall be submitted in duplicate(hard and (or) soft copy)
• A covering letter addressed to the CEO of the Authority,
• Samples of the product as specified in the Authority’s samples Schedule, packed in the final package ready for sale.
• Business Registration Certificate from the Registrar General’s Department
• One original hard-copy and one electronic copy in a text selectable Portable Document Format (PDF), on a CD-ROM and should include MS-Word document for Module 2- see Annex I
• Samples of the FPP as per FDA sample schedule.
• Reference standard for new chemical entities.
• Non-refundable application fee for registration of medicines (Refer to FDA fee schedule).
• Non-refundable GMP inspection fee for facilities not yet inspected by the FDA (Refer to FDA fee schedule).

Office Locations & Contacts

Cover Letter Addressed To:
The Chief Executive, Food and Drugs Authority
P.O. Box CT 2783, Cantonments – Accra GHANA.
Return Completed Form To:
Chief Executive Officer, Food and Drugs Authority,
17 South Legon Commercial Areas, SHIASHIE, ACCRA.
Contact link

Location: Accra
Address: Food and Drugs Authority
Health consultant in Accra,
Ghana. 17 Nelson Mandela Ave, Accra, Ghana.
JRG9+2Q Accra, Ghana
Contactnumber- +233 30 223 3200
Location link

Eligibility

• Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA.
• Domestic and foreign drug manufacturers, re-packers or re-labellers are also required to list all of their commercially marketed drug products.

Fees

A fee is payable on Permit for Herbal products of this form. Please see the fees on our website Link or Link

Validity

• Permit for Herbal products valid for 3 years.

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• Generally, the processing time for this procedure takes up to 1 or 2 months.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• All applications and supporting documents shall be in English and legible. Where material is not originally in English, a copy in the original language and a full translation should be submitted, the accuracy of the translation is the responsibility of the applicant.
• Authentication of the translation has to be done at the nearest Ghana Embassy or by the National Drug Regulatory Authority of the country from where the document originates.
• Reports submitted only in a language other than English will not be accepted.
• The applicant/license holder should indicate that the information submitted is true and correct. Information on the name, position and signature of the applicant should be provided. The application should be dated and stamped by the applicant.

Required Information

• Applicant name
• Residential address of the applicant
• Email id address of the applicant
• Name of contact person
• Current phone and fax numbers
• The name, physical address, telephone number, fax number, and e-mail address of the manufacturer shall be provided.
• Where different activities of manufacture of a given product are carried out at different manufacturing sites, the information on the following should be provided.
• Name of the Manufacturer
• Full Physical address of the Manufacturing Site
• Activity at the manufacturing site
• Declaration

Need for the Document

• FDA approval is required for colour additives used in food, drugs, cosmetics, and some medical devices. Certain high-risk colours also require FDA colour batch certification of every individual batch. Colour additives may only be used in compliance with their approved uses, specifications, and restrictions.

Information which might help

• The FDA was established in 1992 as the Food and Drugs Board (FDB), pursuant to the 1992 Food and Drug Law (PNDCL 305B), later amended by the Food and Drugs ACT of 1996.
• It is the National Regulatory Authority mandated by the public Health Act, 2012 (Act 851) to regulate food, drugs, food supplements, herbal and homeopathic medicines, veterinary medicines, cosmetics, medical devices, household chemical substances, tobacco and tobacco products.
• “HERBAL MEDICINAL PRODUCT” means any finished labeled medicinal product that contains active ingredients, aerial or underground parts of the plant or other plant material or combination used for the purposes of treatment or prevention of a disease or altering normal physiological function, permanently or temporarily in any way in humans.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

These guidelines can be found on FDA website link

Others

The Authority may cancel, suspend or withdraw the registration of herbal medicinal product if:

• The grounds on which the drug was registered is later found to be false
• The circumstances under which the herbal medicinal product was registered no longer exist
• Any of the provisions under which the drug was registered has been contravened
• The standard of quality, safety and efficacy, as prescribed in the documentation for registration, is not being complied with
• The premises in which the herbal medicinal product, or part thereof, is manufactured, packaged or stored by, or on behalf of, the holder of the certificate of registration are unsuitable for the manufacture, packaging or storage of the Product.
• Where the registration of a Product is suspended, withdrawn or cancelled, the Authority shall cause the withdrawal from circulation of that Herbal medicinal product and shall, accordingly, cause the suspension, cancellation or withdrawal to be published in the Gazette.
• Where a Product registration is suspended, withdrawn, or cancelled, an appeal for the review of an application can be made in writing to the Authority, and this shall be accompanied with an application fee, as may be determined by the Authority from time to time