Drug Registration In Ghana

A drug is any substance that causes a change in an organism’s physiology or psychology when consumed.

New applications for registration

This is an application for the registration of a medicinal product that is intended to be placed on the Ghanaian market for the first time.

A new application may only be made by the applicant and he/she shall be the person who signs the declaration portion of the FDA application form as per module 1.

A separate application is required for each product. Products that differ inactive ingredient(s), strength, dosage forms, proprietary names though containing the same ingredients, are considered to be different products and hence require separate applications.

However, products containing the same active ingredients and the same strength made by the same manufacturer at the same manufacturing site, to the same specifications and dosage form, but differing only in packing or pack sizes require only one application.

A new application for registration shall include submission of:

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 the 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).

Applications for Renewal of Registration

Applications for renewal of registration shall be made at least 3 months before the expiry of existing registration by submitting the following:

Dully filled application form for renewal of registration. Refer to annex V

Submit Periodic Safety Update Reports (PSUR)

Samples of the product as per the FDA sample schedule

Nonrefundable application fee for the registration of medicines (refer to FDA fee schedule).

Any other requirements that the FDA may determine from time to time.
Application for Variation of a registered medicinal product
All applications for variation to a registered product shall be made according to requirements stipulated in the FDA Application Guideline for Variation of Registered Medicinal Products.
Annex VI

PAYMENT OF FEES

Every application shall be accompanied by appropriate fees at the time of submission.

Any application that is not accompanied by appropriate fees will not be accepted.

If an application for renewal is not made within three years following the expiration of the registration validity, it shall be considered as a new application for registration.

Who is the Minister of Food and Drugs in Ghana?

The Minister for Health, Hon. Kwaku Agyeman-Manu said that the Government over the year has invested in strengthening regulatory systems in Ghana and is happy that the FDA has given a value that transcends the whole of Africa.

How do I register with FDA in Ghana?

Imported Food Product Information Form (FDA/FM05/IM/02)

Warehouse Location Form (FDA/FM05/IM/03)

Application for Registration as a Food Product Importer Form (FDA/FM05/IM/01) and, where necessary.