| Item in FDA Ghana's checklist | Who prepares it | Why FDA Ghana asks |
|---|---|---|
| Covering letter to the Chief Executive and signed declaration | The applicant: product owner or licence holder | The file is addressed to the Authority and the applicant answers for it |
| Application form FDA/DRI/HEB/SP-01, Appendices I to IV | The applicant, with data from the manufacturer for the ingredient list, specifications, manufacturing summary and shelf life | Ingredients and specifications, a manufacturing summary, other registrations |
| Certificate of Analysis, finished product | The manufacturer: we supply it with every batch | The checklist names it as a document of the file |
| Free sale certificate (foreign product) | The manufacturer side: we arrange it | The checklist names it for a foreign product |
| Stability study reports | The manufacturer and the applicant, agreed before the first order | The guideline asks for WHO zone IVb conditions, in the pack sold in Ghana |
| Samples, as per the FDA's sample schedule, in final sale packaging | Produced by the manufacturer; the applicant sends them through the local agent | The guideline asks for samples in the final packaging |
| Four copies of the label and packaging material; four copies of the package insert | The manufacturer prints the carton and the leaflet to the applicant's artwork | FDA Ghana checks the text against its labelling rules |
| Evidence of the contract, for a product made under contract | The brand owner and the manufacturer | The guideline asks for it, and for the label and insert to state it |
| Business registration certificate of the importer | The importer | FDA Ghana's importer guideline lists it for food importers |
The checklist is the one printed in FDA Ghana's application form for a food, dietary or nutritional supplement (FDA/DRI/HEB/SP-01, revision 01, effective 07/2020). The rules come from the FDA's supplement registration guideline, FDA/HMD/GL-FS/2012/01, issued 1 March 2013. This article reports what the regulator published and is not legal advice; your importer confirms what applies to your product.
Who applies for Ghana FDA registration of a food supplement: the manufacturer or a local agent?
The product owner or the licence holder applies. The guideline adds that a licence holder's representative may not hold itself out as the applicant unless it owns the product. A manufacturer in the EU that does not own the brand is therefore not the applicant; the brand owner, or the licence holder it appoints, is.
The application form has a separate line for a local agent: samples and printed matter are forwarded to the Authority through the agent, while customs duty and clearance are the applicant's. The importing company has its own registration with FDA Ghana: the importer guideline for food (FDA/FERD/GL-REG/2013/01) asks for the Imported Food Product Information Form, a copy of the business registration certificate and a fee, and bars clearing agents from completing the form. Whether it applies to your supplement, your importer confirms.
We supply the manufacturer's side of the file. The brand owner, or its importer, files it with our documents.
Which category does a food supplement fall into at FDA Ghana?
FDA Ghana treats it as a Food/Dietary or Nutritional Supplement: concentrated sources of nutrients or other substances in a pharmaceutical dosage form such as tablets, capsules, sachets, syrups and powders. Vitamins and minerals fall inside the definition at a concentration below the recommended daily allowance. The guideline adds that the Authority must confirm the product needs registration in Ghana. Whether a blister changes the class is answered in our article on whether a blister makes a supplement a medicine.
What documents does the manufacturer provide for the FDA Ghana application form?
Appendix I, product specifications. Every active and non-active ingredient with approved name, quantity per dosage unit, specification and function; a pharmacopoeia reference is accepted. Also specifications of the packaging materials.
Appendix II, manufacturing procedure and controls. A brief manufacturing summary, the final analytical report and authorisation for release, the proposed shelf life and the stability data behind it. Our standard shelf life is 24 months, stated in the product documents. The Certificate of Analysis that comes with every batch goes into the file, and we confirm with your importer before production which release document the form needs.
Appendix III, administrative status. Registrations in other countries and the manufacturing plants from which Ghana can be supplied.
Certificate of Analysis and plant certificates. A finished-product Certificate of Analysis and the product specification come from us with every batch. Copies of the plant's ISO 22000, GMP and HACCP certificates, with their numbers, are sent on request.
Free sale certificate. The checklist lists one for a foreign product. We arrange the Certificate of Free Sale, and the Certificate of Manufacture where a file asks for one.
FDA Ghana asks that every certificate in the file be in English. State this in your enquiry, together with the list your importer has received.
Does FDA Ghana ask for stability data, and under which conditions?
Yes. The guideline asks for stability studies in the container closure system in which the product will be marketed in Ghana, under WHO zone IVb conditions: six months of accelerated testing at 40 °C ± 2 °C and 75% RH ± 5%, and long-term testing to the end of the shelf life. For a tablet or capsule in a blister, that means the study belongs to the blister and carton you will sell, not to a bottle of the same formula.
The study is part of the registration file, and a change of pack after it is a variation. The batches and the pack the study covers are agreed with your importer before the first order.
What does FDA Ghana check on a supplement label?
FDA Ghana's general labelling requirements for pre-packaged food (form FDA/FER/RQT-04, effective date printed 02/01/20, citing guideline FDA/FERD/GL-LAB/2013/02) list these items on the label:
- product name (brand and generic), net weight or volume, ingredients by specific name
- date of manufacture, best before or use by date, batch or lot number
- country of origin, name and complete address of the manufacturer or agent
- directions for use and storage instructions, where they apply
- English, legible, in indelible ink
The same sheet says that where a product has both primary and secondary packaging, the labelling of both has to conform, and that documentary evidence must support any nutrition information and claims on the label. The supplement guideline adds two points: the label and the package insert state that the product is made under contract where that is so, and the label text follows Ghana's labelling regulations.
For a blister, the primary pack is the blister and the secondary pack is the carton. We print the batch number, the production date and the expiry date on the carton, and the lidding foil is printed for your brand (the film classes are compared on blister films). The label text goes to your importer for confirmation before you approve the artwork.
A printed leaflet goes into the carton, to your artwork, which covers the package insert FDA Ghana asks for in four copies. The language of the label is English, as the FDA's sheet states.
What are the FDA Ghana registration fees for imported supplements?
FDA Ghana's fee schedule, issued under the Fees and Charges (Miscellaneous Provisions) Regulations 2023 (L.I. 2481), lists these amounts for food supplements:
| Item | Amount in the schedule |
|---|---|
| Registration of an imported supplement, 1 to 50 products, per annum | Cedi equivalent of US$100 |
| Registration of an imported supplement, 51 to 100 products, per annum | Cedi equivalent of US$70 |
| Registration of an imported supplement, more than 100 products, per annum | Cedi equivalent of US$60 |
| Variation of an imported supplement, per activity | Major US$300; minor US$150 (cedi equivalent) |
| Label evaluation before registration, per product, per variant | GH¢200 |
| Verification of imported food supplements at the port | 1.30% of FOB value |
The schedule does not itemise a separate fee for supplement renewal or for an import permit, and the file shows no effective date, so your importer confirms the amounts that apply on the day of filing. The supplement guideline calls the application fee non-refundable and says registration is valid for three years, while the schedule states the registration figures per annum; your importer confirms how the two are applied.
How long does FDA Ghana registration take?
FDA Ghana's food supplement registration page gives 12 months (360 days) for a new application, 6 months for a fast-track application, 3 months for a reliance application and 3 months for a renewal. Variations take 3 months for a minor one and 6 months for a major one. The page shows no publication date and does not say which route a given supplement takes, so your importer confirms the route with the Authority.
For a blister run, production takes 6 to 10 weeks from 2,000 cartons printed for your brand. FDA Ghana evaluates the label and asks for samples in final packaging, so the label and the carton are settled before the file is filed: a later change is a variation with its own fee and its own wait.
Does FDA Ghana inspect the manufacturer's site?
It may. The guideline says the Authority may conduct a GMP audit inspection of the manufacturing facility, for a fee. The plant's certificates are provided with their numbers on request, for any file or importer that asks for them. A visit to the plant is possible, and a sample can be sent before you order.
Do the documents for Ghana need an apostille or legalisation?
Ghana is not recorded as a party to the Apostille Convention in the HCCH status table (update of 30 June 2026), so an apostille does not replace legalisation for a Ghanaian file. Your importer confirms with FDA Ghana which route a document takes. We arrange the Certificate of Free Sale, the Certificate of Manufacture and the consular legalisation where the country of sale asks for it. The wider picture is on our export documents page.
Questions buyers ask about Ghana FDA registration
Who files the Ghana FDA registration for an EU food supplement?
The product owner or the licence holder files with FDA Ghana. A licence holder's representative may apply only if it owns the product. The manufacturer supplies the technical documents, and the application form has a separate line for a local agent through which samples and printed matter are forwarded.
How much does Ghana FDA registration cost for an imported supplement?
The fee schedule under L.I. 2481 lists the cedi equivalent of US$100 per annum for 1 to 50 imported products, US$70 for 51 to 100 and US$60 above 100. Variations cost US$300 for a major and US$150 for a minor one, and port verification is 1.30% of FOB value.
How long does a Ghana FDA supplement registration take?
FDA Ghana's registration page gives 12 months (360 days) for a new application, 6 months on the fast-track route, 3 months for a reliance application and 3 months for a renewal. The page carries no date, so your importer confirms the route and the current timeline.
Does the supplement label for Ghana have to be in English?
Yes. FDA Ghana's general labelling requirements for pre-packaged food say labelling shall be in English, legible and in indelible ink. They list the name, net content, ingredients, manufacture and best before dates, batch number, country of origin, manufacturer or agent and storage instructions.
What stability data does FDA Ghana want for a supplement?
Studies in the container closure system in which the product is marketed in Ghana, under WHO zone IVb conditions: six months of accelerated testing at 40 °C and 75% RH, and long-term testing to the end of the shelf life. For a blister, the study belongs to the blister pack you sell.
Does a free sale certificate come with the supplements?
Yes. We arrange the Certificate of Free Sale and the Certificate of Manufacture, with the apostille or consular legalisation where the country of sale asks for it. FDA Ghana's checklist lists a free sale certificate for a foreign product.
Can a private label supplement made under contract be registered in Ghana?
Yes, with evidence of the contract in the file, and with the label and the package insert stating that the product is made under contract. Agree the wording with your importer before you approve the artwork.
Are these Ghana FDA rules current?
Check before you file. The supplement guideline is dated 1 March 2013, the application form carries an effective date of 07/2020, and the fee schedule file shows no effective date. Your importer confirms the current versions with FDA Ghana.
Read more
West Africa · Export documents · Quality and batch documents · Africa · Blister packing · Climatic zones by country · Shelf life and storage · White label supplements · Private label supplements · Blister films · Tablets in blisters
Ask about the documents for Ghana
Send us the product, the dosage form, whether you own or distribute the brand and the list your importer has received from FDA Ghana. We answer within 24 hours, Monday to Friday.
For tablets and capsules in a blister, a run starts from 2,000 cartons printed for your brand, at least 4,000 blisters, with a ready-made formula or your own, and production takes 6 to 10 weeks. Each carton holds 1 to 4 blisters, and the lidding foil is printed for your brand as well.
Request a quote → Email sales@hyperpharm.eu
Sources
- Food and Drugs Authority, Ghana: Application Form for the Registration of a Food/Dietary/Nutritional Supplement, DOC NO. FDA/DRI/HEB/SP-01, rev. 01, effective 07/2020. Used for: the checklist, Appendices I to IV, the local agent line, the note on samples. fdaghana.gov.gh. Checked 18 October 2026.
- Food and Drugs Authority, Ghana: Guideline for Registration of Food/Nutritional/Dietary Supplements, FDA/HMD/GL-FS/2012/01, version 01, first adopted 1 February 2013, issued 1 March 2013. Used for: the definition, the applicant, general requirements, contract manufacture, stability conditions, GMP audit, validity. fdaghana.gov.gh. Checked 18 October 2026.
- Food and Drugs Authority, Ghana: Fees and Charges (Miscellaneous Provisions) Regulations, 2023 (L.I. 2481), approved fees and charges; the file shows no effective date. fdaghana.gov.gh. Checked 18 October 2026.
- Food and Drugs Authority, Ghana: Food Supplement Registration, service page with processing timelines; no publication date shown. fdaghana.gov.gh. Checked 18 October 2026.
- Food and Drugs Authority, Ghana: General Labelling Requirements for Pre-packaged Food, DOC NO. FDA/FER/RQT-04, ver. 01, effective date printed 02/01/20, citing FDA/FERD/GL-LAB/2013/02. fdaghana.gov.gh. Checked 18 October 2026.
- Food and Drugs Authority, Ghana: Guidelines for Registration as an Importer of Food, FDA/FERD/GL-REG/2013/01, issued 1 March 2013. fdaghana.gov.gh. Checked 18 October 2026.
- Hague Conference on Private International Law (HCCH): status table of the Apostille Convention, update of 30 June 2026. Ghana is not listed. hcch.net. Status as recorded on our export documents page, checked 13 October 2026.