Like most countries, Ghana’s Food and Drugs Authority (F.D.A) exists to ensure the safety of its residents. But, how do entrepreneurs and start-ups register their new products? Today, we take a closer look at this process to learn how to register a product with the FDA in Ghana.

History of Ghana’s Food and Drugs Authority

The Food and Drugs Board was established by the Food and Drugs Law 1992 (PNDCL 305B) and was amended by the Food and Drugs (Amendment) Act 523, 1996, to provide for the fortification of salt to alleviate nutritional deficiencies and to bring the provisions of the law in conformity with the 1992 Constitution of Ghana.

In 1992, the constitution separated the control of drugs other than narcotics from the practice of Pharmacy. The Food and Drugs Law, was then enacted to control the manufacture, importation, exportation, distribution, use and advertisements of food, drugs, cosmetics, chemical substances and medical devices.

Subsequently, The Pharmacy Act 1994 (Act 489) was passed in 1994 to establish the Pharmacy Council to control the practice of the Pharmacy profession and the registration of pharmaceutical companies. The Food and Drugs Board however became an Authority with the name Food and Drugs Authority in 2012 by the passage of the Public Act, Act 851, 2012.

The Food And Drugs Authority is also responsible for the inspection and certification of food products and prescription drugs if deemed appropriate without posing health risk to citizens. Other functions of the Agency include:

• Ensure adequate and effective standards for food, drugs, cosmetics, household chemicals and medical devices
  Monitor through the District Assemblies and any other agency of State compliance with the provisions of Part 6, 7 and 8 of the Public Health Act, 2012 (ACT 851).
• Advise the Minister on measures for the protection of the health of consumers
• Approve the initiation and conduct of clinical trials in the country
• Perform any other functions that are ancillary to attaining the objects of the Authority
• To ensure that all food, drugs and cosmetic product related advertisement broadcasted to the mass is vetted and approved.

The FDA also collaborates with some of the country’s institutions including: The Food Research institute, Pharmacy Council of Ghana, Ghana Standards Authority, Environmental Protection Agency, Ghana Revenue Authority, Centre for Plant Medicine Research, University of Ghana, Kwame Nkrumah University of Science and Technology, amongst others.

How to register a product with the FDA in Ghana

The registration process involves the review of the manufacturing process ingredients and assessment of the safety and quality of the product. It is worth noting that the process can take its time due to nature and number of tests that are run to ensure that the products meet the compliance and standards of the FDA.

The registration of the applicant’s product, only last for 3 years and is subject to renewal.

FDA Ghana requirements for important pre-packaged foods

To register a new food product in Ghana’s FDA, applicants must follow the under listed steps:

• The applicant must first purchase the registration form the FDA district office and proceed to fill with the necessary details for submission.
• The applicant is required to fill out the following forms:
  • Imported food product information.
  • Warehouse location form.
  • Application for cold storage facility license.
  • Application for dry food storage facility license.
  • The applicant must provide valuable information pertaining to his business establishment, contents and process of the product and the exact location of his factory or place of production.

The applicant must also provide and submit the following in tandem with the application:

• A copy of the applicant’s Business Registration Certificate.
• A copy of sanitary or phytosanitary (SPS) certificate where applicable.
• Copy of Health/ Food handlers test where applicable.
• Certificate of tuberculosis, Hepatitis A, Typhoid and other communicable diseases for each worker on the production line.
• Copy of product label.
• Certificate of analysis for each product and variant.
• The applicant must also provide samples units for testing and cover the registration fees stipulated on the application forms.
• The applicant must also complete the registration, three months from initial application or will be required to re-apply or start the process again.

Check out the Ultimate Food Guide for Accra

FDA Ghana requirements for imported pre-packaged foods

For applicant seeking to register their imported products with the Ghana Food and Drugs Board Authority, must purchase the following forms from the FDA district or regional offices and fill them:

• Imported food product information form.
• Warehouse location form
• Application for dry food storage facility license.
• Application for cold storage facility license.

The applicant after filling the above forms must submit to the FDA in addition to the following:

• Business Registration Certificate.
• Certificate of analysis performed in the country of origin which should also be a comprehensive certificate of products analysis issued by the manufacturer indicating the name and designation of the analysis.
• The applicant must submit a sanitary or phytosanitary (SPS) certificate where applicable.
• Certificate of manufacturer and free sale issued by an accredited health authority.
• Radiation certificate for food products where applicable.
• Documentation substantiating any claim on health, nutrition, superlative etc. on the label where applicable.
• The applicant must provide 6 product samples for testing at the FDA.
• Applicants must pay all stipulated Ghana FDA registration fees stated on the application forms.
• All importers are also required to submit the certificate of registration of brand name/ trademark in the name of the owner of the trademark to the FDA.

How to get FDA approval for food in Ghana

In order to get FDA approval for food products in Ghana, you must comply with these requirements:

1. The product labeling should be in English.
2. The label must have the contact details of the local distributor/ marketer / representative of the product.
3. The product packaging must indicate clearly the product mineral comparison, volume, net weight and place of manufacturing.
4. Food products labels must not contain any adjective describing the product as having superior/ additional health and nutritional benefits as this contravenes the UN Convention on food labeling.
5. The storage facility for your food products must be fumigated by a pest control company before the storage facility can be licensed.
6. The Food and Drugs Board Authority Act requires all food products should carry expiring dates or shelf life.
7. The active ingredients should be specified on the packaging where applicable.
8. The FDA regulation states that the expiry date should be “at least half the shelf life as at the time of inspection at the port of entry”
9. If the applicant satisfies the aforementioned criteria, the Food and Drugs Board (FDA), will award them the required licenses to operate and have their products on the market.

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