Supplying Medicines and Supplements to Spain
A practical guide for buyers worldwide sourcing from Spain, and for manufacturers and exporters selling into it.
This page in other languages: English · Español
Spain works inside the EU system. To sell a medicine there, you need a marketing authorisation from the EU or from the AEMPS, a licence holder established in the EU or EEA, and a qualified person who certifies every imported batch. Public funding is then decided nationally by the Ministry of Health's pricing commission. Packs and leaflets must be in Spanish.
For buyers abroad, Spain is a source of originator medicines, clinical-trial comparators, APIs and contract manufacturing, all under EU GMP. The AEMPS issues WHO-format certificates (CPPs), including for medicines made in Spain only for export, and free sale certificates for active substances marketed in Spain.
Spain at a glance
| Regulator | AEMPS (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 | The Ministry of Health's Interministerial Commission on Medicine Prices (CIPM) decides public funding; hospital tenders follow EU procurement rules |
| Unlicensed / named-patient route | Foreign medicines authorised by the AEMPS case by case, requested by the hospital pharmacy or a regional contact point |
How to supply medicines to Spain
- 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 AEMPS to test Spain 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 funding are national. The Ministry of Health's Interministerial Commission on Medicine Prices (CIPM) decides whether new medicines are funded by the national health system. Hospital tenders follow the EU procurement directive, which lets buyers weigh quality and supply as well as price. Our tender supply service supports bidders.
The AEMPS can exceptionally authorise a medicine not authorised in Spain when no suitable alternative is available. Hospital pharmacies request it through the AEMPS application for medicines in special situations, with a medical report, and outpatient medicines go through each region's foreign-medicine contact point. See named-patient and special import and government tender supply.
Sourcing from Spain
- Originator medicines and comparators. Licensed wholesalers in Spain 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 Spanish 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 Spain, ask for the CEP or ASMF. Companies registered with the AEMPS for active substances can get a free sale certificate confirming the API is marketed in Spain under the applicable rules. 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. The AEMPS issues Certificates of Pharmaceutical Product following WHO guidelines, applied for by the licence holder or someone it authorises. Certificates are also available for medicines not registered in Spain and for intermediates and bulk products, and an apostille is added automatically for Hague Convention countries. The EMA covers centrally authorised medicines. See our guide to the CoPP and our documentation and quality pack.
Supplements
In Spain, food supplements are foods, not medicines, and are covered by Royal Decree 1487/2009. Each product must be notified to the authorities before or when it is first placed on the market, and it then appears in the public food business register. Claims follow EU rules, 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 Spain search for
Semrush data from October 2026 shows that people in Spain search most for ashwagandha (about 165,000 searches a month), creatine (“creatina”, 135,000, plus 40,500 for “creatina monohidrato”), vitamin D (“vitamina d”) and omega-3 (74,000 each) and vitamin B12 (“vitamina b12”, 60,500).
Spanish generic names lead medicine searches: “prednisona” (about 45,600 a month), “metamizol” (36,700), “omeprazol” (27,900) and “naproxeno” (27,100). Brand names for dexketoprofen (35,700) and metamizole (28,200) are searched heavily too.
How importers, pharmacies and manufacturers in Spain search
“private label mfg” gets about 2,900 searches a month and “private label” about 320. Most other trade searches look for individual companies by name.
Originator brands searched by name include Enantyum (dexketoprofen). 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 prednisone, metamizole, dexketoprofen and omeprazole. Some examples we list:
En español: Importar medicamentos en Europa y Turquía: guía país por país (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 Spain?
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