Supplying Medicines and Supplements to France
A practical guide for buyers worldwide sourcing from France, and for manufacturers and exporters selling into it.
This page in other languages: English · Français
France works inside the EU system. To sell a medicine there, you need a marketing authorisation from the EU or from the ANSM, a licence holder established in the EU or EEA, and a qualified person who certifies every imported batch. Price and reimbursement are then decided in France, after the HAS has assessed the medicine. Packs and leaflets must be in French.
For buyers abroad, France is a source of originator medicines, clinical-trial comparators, APIs and contract manufacturing, all under EU GMP. The EDQM, which issues CEPs for APIs, is based in Strasbourg. Export certificates in the WHO format come from the Paris Île-de-France Chamber of Commerce, or from the EMA for centrally authorised medicines.
France at a glance
| Regulator | ANSM (national agency); EMA and the European Commission for centralised approvals |
|---|---|
| Who holds the licence and imports | A holder established in the EU or EEA; imports from outside the EU need a manufacturing and import authorisation and a qualified person |
| Registration routes | EU centralised (EMA), decentralised, mutual recognition or national; the applicant must be established in the EU or EEA |
| Fast or reliance routes | No reliance on foreign approvals; an approval in one member state can be recognised by others, and some new medicines get accelerated assessment at the EMA |
| Public buying and reimbursement | HAS assesses; CEPS negotiates the price and UNCAM sets the reimbursement rate; hospital tenders follow EU procurement rules |
| Unlicensed / named-patient route | Compassionate access authorisation (AAC) from the ANSM, requested by a hospital prescriber and hospital pharmacist |
How to supply medicines to France
- Find a licence holder in the EU. The marketing authorisation holder must be established in the EU or EEA. Many exporters license their dossier to a European company, which then files and holds the licence. Our dossier licensing and registration service can help you find one.
- Choose the registration route. Use the decentralised route for a multi-country launch, mutual recognition to extend an existing EU approval, or a national application to the ANSM to test France alone. The centralised route through the EMA is compulsory for biotech medicines, advanced therapies, orphan medicines and new active substances for some diseases. A generic can be filed once the reference has been authorised for eight years and sold after ten. Our Europe import guide explains each route, and our list of medicines going generic shows what is coming off patent.
- Plan import and batch release. Importing from outside the EU needs a manufacturing and import authorisation with a qualified person, who certifies each batch. Without a mutual recognition agreement, that usually means testing the batch again inside the EU. Your API needs a CEP or ASMF, plus a written confirmation from the exporting country's regulator unless that country is on the EU's exempt list. Wholesalers must follow EU good distribution practice.
- Agree price, reimbursement and tenders. Pricing and reimbursement are national. The HAS Transparency Committee assesses the medical benefit, the CEPS negotiates the price with the company, and UNCAM sets the reimbursement rate. Hospital tenders follow the EU procurement directive, which lets buyers weigh quality and supply as well as price. Our tender supply service supports bidders.
For a medicine with no French authorisation, a hospital prescriber and hospital pharmacist can ask the ANSM for a compassionate access authorisation (AAC) for one patient with a serious, rare or disabling disease and no suitable treatment. The AAC also serves as the import authorisation, and the hospital pharmacy orders the medicine. See named-patient and special import and government tender supply.
Sourcing from France
- Originator medicines and comparators. Licensed wholesalers in France can supply originator medicines for clinical trials and for markets abroad. Under EU rules, exporting medicines counts as wholesale distribution, so the supplier needs a wholesale distribution or manufacturing authorisation. Packs carry French text and EU safety features, so plan any relabelling or blinding early. See our comparator supply service and our guide to comparator sourcing for clinical trials.
- APIs and their documents. For APIs made in France or elsewhere in Europe, ask for the CEP or ASMF. CEPs are issued by the EDQM, a Council of Europe body based in Strasbourg. Our guides to CEP vs DMF vs ASMF and drug master files explain what to ask for, and our API supplier service can help you find a source.
- Contract manufacturing. Plants work to EU GMP and are inspected by the national inspectorate. GMP certificates and manufacturing authorisations are listed in the EU's EudraGMDP database, which buyers can search. Our contract manufacturing guide explains how to brief a plant, and our white-label manufacturing service can match you with one.
- Export documents. Since October 2015, WHO-format medicine certificates (CPPs) and free sale certificates have been issued by the Paris Île-de-France Chamber of Commerce, not the ANSM. Certificates for centrally authorised medicines come from the EMA. Exporting a medicine with no French authorisation outside the EU needs an export declaration to the ANSM first. See our guide to the CoPP and our documentation and quality pack.
Supplements
Food supplements must be declared before they are first sold in France, through the Compl'Alim online service run by the Ministry of Agriculture's food directorate (DGAL). Ingredients must come from national positive lists of nutrients, plants and other substances; one legally sold elsewhere in the EU needs an attestation before sale. The DGCCRF checks labels and advertising, so keep disease claims off the pack. We help brands get supplements made under their own label by GMP-certified contract manufacturers: see nutraceutical private label.
What people in France search for
Semrush data from October 2026 shows that people in France search most for vitamin B12 (“vitamine b12”), vitamin D (“vitamine d”), ashwagandha and creatine (about 90,500 searches a month each), magnesium (74,000) and probiotics (“probiotique”, 60,500).
Medicines are mostly searched by their French generic names: “prednisolone” (about 43,400 searches a month), “desloratadine” (32,500), “atorvastatine” and “pantoprazole” (23,400 each), “ketoprofene” (22,600) and “prednisone” (21,500).
How importers, pharmacies and manufacturers in France search
Trade searches are mostly in English: “private label mfg” gets about 3,600 searches a month and “contract manufacturing” about 140. In French, “sous traitance transport pharmaceutique” (outsourced pharmaceutical transport) gets about 170.
Originator brands searched by name include Eliquis (apixaban). Brand names are trademarks of their owners and are used only to identify the medicine.
Supplements we can help you make
Often searched medicines include prednisolone, desloratadine, atorvastatin and pantoprazole. Some examples we list:
En français: Importer des médicaments en Europe et en Turquie : guide pays par pays (2026)
Documents to ask your supplier for
- A Certificate of a Pharmaceutical Product (CoPP) in WHO format.
- The plant's GMP evidence, such as a WHO-GMP, EU-GMP or PIC/S certificate, plus any inspection by your regulator.
- The registration dossier (CTD or ACTD), with bioequivalence data for generics where required.
- Stability data for hot climates.
- A Certificate of Analysis for every batch.
Not sure a supplier is genuine? Read how to verify a pharmaceutical supplier. For the neighbouring markets, see our Europe and Turkey import guide.
Sourcing for France?
Send the product, strength, quantity and the documents your regulator needs. We will match you with GMP-certified manufacturers and suppliers who can serve your market, wherever they are based.
Send your requirement Talk to our team