Getting a US-approved medicine in Ghana: the legal route, documents and timing
A sourced guide for patients, families and doctors in Ghana, checked against FDA Ghana rules on 17 October 2026.
Reviewed by the Reserve Meds clinical operations team on 17 October 2026. Sources accessed 17 October 2026.
The short answer
In Ghana, the Food and Drugs Authority allows an unregistered biological medicine to be imported for a named patient when registered treatments do not meet the patient's needs. The importer and the treating doctor complete FDA Ghana's application form, the doctor takes full responsibility, and a permit covers up to three months' supply and is valid for six months.
- Regulator: Food and Drugs Authority (FDA Ghana).
- Main route: Importation of an unregistered biological product for a named patient.
- Who applies: The importing company, hospital or clinic, with the requesting doctor.
- Price: Quote on request.
Who regulates medicines in Ghana
FDA Ghana regulates medicines under the Public Health Act 851 of 2012, which requires biological medicinal products to meet standards of quality, safety and efficacy. Its named-patient guideline, version 02, came into effect on 5 September 2025 and was developed with technical support from the World Health Organization.[1]
The legal route for a medicine that is not registered in Ghana
The guideline applies where a patient's therapeutic needs are not adequately met by registered and available treatments. Permission covers one consignment, to be imported within six months of approval. The import and supply are made by the company, hospital or clinic named in the application, on behalf of the requesting doctor, and the product is supplied directly for the patient.[1]
The requesting doctor signs a declaration that the product has not been evaluated by FDA Ghana, that it is requested to treat a patient under their care, and that they take full responsibility for its use. The doctor also keeps records of the patient's name, ID number and contact details.[1]
The guideline covers biological products such as biologic medicines and vaccines. For other unregistered medicines, the hospital confirms the applicable FDA Ghana procedure.
Documents you will usually need
FDA Ghana's guideline asks for:[1]
- The FDA Ghana application form: Sections A and B completed and signed by the importer
- Section D completed and signed by the requesting doctor, including the purpose (named patient) and the doctor's declaration
- Product details: name, dosage form, strength, active ingredient, pack size, route and quantity
- Packaging, labels and package insert in English
Timing, quantities and fees
The permit allows a quantity of up to three months' supply, at FDA Ghana's discretion, and is valid for six months from issue, or until the product receives a Ghanaian product licence.[1]
How a US-approved medicine reaches a patient in Ghana
First, confirm the medicine is approved in the US. FDA's Drugs@FDA database lists approved prescription medicines and links to the approved label.[2]
In Ghana the hospital or importer files with FDA Ghana together with the treating doctor. Once permission is granted, we ship from the US through our wholesale partner to the importer named on the permit, with English labelling and the product insert.
Once the local permission is in place, the medicine is bought from the US supply chain, packed for the temperature the label requires, and shipped to the named hospital, clinic or importer with the documents customs will ask for. Cold-chain medicines need a validated shipper and a temperature record for the whole journey.
If the medicine is a cell or gene therapy, the rules are different: these are usually given only at qualified treatment centers chosen by the manufacturer, so the realistic route is often treatment at a center abroad rather than import.[3]
Practical checks before you start
- Ask the treating specialist whether a registered alternative already exists in Ghana. Most special routes only apply when it does not.
- Check whether the medicine is a controlled drug. Controlled medicines need extra permits in almost every country.
- Ask the hospital pharmacy whether it has handled this route before and who signs the application.
- Keep copies of every document and approval. Customs and the hospital will ask for them again at delivery.
How Reserve Meds helps
Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help families and treating doctors understand the route, prepare the documents the regulator or hospital asks for, arrange supply from the US once approval is in place, and keep everyone updated. We do not diagnose, prescribe or decide what a regulator approves.
We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them. Your coordination fee is quoted in writing for your case before you commit. No hidden charges. We give you a written timeline estimate for your case before you commit.
Ask us about a medicine for a patient in Ghana
Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.
Frequently asked questions
Can a hospital in Ghana import an unregistered biologic for one patient?
Yes. FDA Ghana's guideline allows import for a named patient when registered treatments do not meet the patient's needs, with a doctor's declaration of responsibility.
How much can be imported and for how long is the permit valid?
Up to three months' supply, at FDA Ghana's discretion. The permit is valid for six months or until the product is licensed in Ghana.
Does the packaging need to be in English?
Yes. The guideline requires packaging, labels and package inserts in English.
Does Reserve Meds apply to the regulator for us?
No. The application is made by the person or institution the rules name, usually the treating doctor or hospital. We help prepare the paperwork, confirm the US approval and arrange supply from the US once permission is granted.
How much does it cost?
Quote on request. The total depends on the medicine, the dose, shipping, import steps and coordination. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.
Sources for these answers: [1]
Sources
All sources were opened and checked on 17 October 2026. Rules and labels change, so the treating hospital or regulator confirms the current position before anything is filed.
- Food and Drugs Authority Ghana: Guideline and Application Form for the Importation of an Unregistered Biological Product for a Named Patient (effective 5 September 2025) (accessed 17 October 2026)
- US FDA: How do I find out if a drug is approved? (accessed 17 October 2026)
- US FDA: Approved Cellular and Gene Therapy Products (accessed 17 October 2026)
Related
- All country guides
- Named-patient access, explained
- US expanded access (compassionate use)
- Answers to common access questions
- How cold-chain medicines are shipped
This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.