Supplying Medicines and Supplements to Italy
A practical guide for buyers worldwide sourcing from Italy, and for manufacturers and exporters selling into it.
This page in other languages: English · Italiano
Italy works inside the EU system. To sell a medicine there, you need a marketing authorisation from the EU or from AIFA, a licence holder established in the EU or EEA, and a qualified person who certifies every imported batch. AIFA then negotiates price and reimbursement for the national health service. Packs and leaflets must be in Italian.
For buyers abroad, Italy is a source of originator medicines, clinical-trial comparators, APIs and contract manufacturing, all under EU GMP. AIFA inspects the plants and issues their GMP certificates, and it issues WHO-format certificates (CPPs) for medicines authorised in Italy. Food supplements reach the Italian market only after their label is notified to the Ministry of Health.
Italy at a glance
| Regulator | AIFA (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 | AIFA negotiates price and reimbursement for the national health service; hospital tenders follow EU procurement rules |
| Unlicensed / named-patient route | A doctor's request for one patient; import clearance for medicines not authorised in Italy comes from the Ministry of Health's border health offices (USMAF) |
How to supply medicines to Italy
- 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 AIFA to test Italy 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. AIFA sets prices and negotiates reimbursement agreements with companies for medicines paid for by the national health service. Hospital tenders follow the EU procurement directive, which lets buyers weigh quality and supply as well as price. Our tender supply service supports bidders.
EU rules let a doctor order an unauthorised medicine for one patient under their care. In Italy, import clearance for a medicine not authorised in Italy is issued by the Ministry of Health's border health offices (USMAF), so hospital pharmacies and licensed importers should plan for that step. See named-patient and special import and government tender supply.
Sourcing from Italy
- Originator medicines and comparators. Licensed wholesalers in Italy 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 Italian 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 Italy, ask for the CEP or ASMF and the site's GMP status. AIFA runs separate GMP inspections for API plants. 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. In Italy, AIFA inspects medicine plants and issues their GMP certificates. 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. AIFA issues Certificates of Pharmaceutical Product, based on the WHO model, for medicines authorised in Italy through the national, mutual recognition or decentralised routes. The licence holder applies, one pack per request, and the certificate is valid only for countries outside the EU and EEA. The EMA issues certificates for centrally authorised medicines. See our guide to the CoPP and our documentation and quality pack.
Supplements
Food supplements can only be sold in Italy once their label has been notified to the Ministry of Health. Products that pass are entered in the Ministry's published register of supplements and get a code, and plants that make or pack supplements need to be approved. 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 Italy search for
Semrush data from October 2026 shows that people in Italy search most for vitamin D (“vitamina d”, about 135,000 searches a month), ashwagandha (90,500), vitamin B12 (“vitamina b12”) and omega-3 (74,000 each) and creatine (“creatina”, 60,500).
Italians often look up medicines by brand name. The top searches are brand names for ibuprofen (about 80,000 a month), betamethasone (67,500), amoxicillin with clavulanic acid (45,000) and hyoscine butylbromide (43,000). Among generic names, “pantoprazolo” gets about 35,200.
How importers, pharmacies and manufacturers in Italy search
“private label” (about 1,900 searches a month) and “private label mfg” (1,600) lead the trade searches. Italian searches for contract cosmetics production, “produttore cosmetici” and “produzione cosmetici conto terzi”, get about 590 each.
Originator brands searched by name include Augmentin (amoxicillin and clavulanic acid). 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 ibuprofen, betamethasone, amoxicillin with clavulanic acid and pantoprazole. Some examples we list:
In italiano: Importare medicinali in Europa e Turchia: guida paese per paese (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 Italy?
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