Supplying Medicines and Supplements to the Netherlands
A practical guide for buyers worldwide sourcing from the Netherlands, and for manufacturers and exporters selling into it.
This page in other languages: English · Nederlands
The Netherlands works inside the EU system and is home to the EMA in Amsterdam. To sell a medicine there, you need a marketing authorisation from the EU or from the CBG, a licence holder established in the EU or EEA, and a qualified person who certifies every imported batch. For generics, health insurers' preference policy decides which brand gets reimbursed.
For buyers abroad, the Netherlands is a source of originator medicines, clinical-trial comparators, APIs and contract manufacturing, all under EU GMP. The IGJ inspects plants and issues GMP certificates, and Farmatec, part of the health ministry's CIBG, issues export certificates (CPPs) in line with the WHO scheme for medicines registered in the Netherlands.
The Netherlands at a glance
| Regulator | CBG-MEB (national authorisations) and the IGJ (inspections); 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 health minister decides which medicines enter the GVS, advised by Zorginstituut Nederland; insurers choose preferred generic brands |
| Unlicensed / named-patient route | Supply on a doctor's declaration (artsenverklaring), with an exemption from the IGJ |
How to supply medicines to the Netherlands
- 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 CBG to test the Netherlands 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. Pharmacy medicines are reimbursed only if the health minister has placed them in the medicine reimbursement system (GVS), on the advice of Zorginstituut Nederland. Where several makers offer the same medicine, an insurer may name one preferred brand and reimburse only that one, so generic supply depends on winning those choices. Hospital tenders follow the EU procurement directive. Our tender supply service supports bidders.
When a doctor finds that a patient cannot be treated with medicines authorised and available in the Netherlands, they sign a doctor's declaration (artsenverklaring). A pharmacy, wholesaler or manufacturer then applies to the IGJ for an exemption and may supply only once it is granted. See named-patient and special import and government tender supply.
Sourcing from the Netherlands
- Originator medicines and comparators. Licensed wholesalers in the Netherlands 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 Dutch 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 the Netherlands, ask for the CEP or ASMF and check the site's GMP status. 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 the Netherlands, the IGJ inspects plants and issues GMP certificates when they comply. 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. Farmatec, part of the health ministry's CIBG, issues the Dutch export certificate (CPP) in line with the WHO certification scheme, at the request of the licence holder or manufacturer, for medicines registered in the Netherlands. It does not cover Opium Act medicines. The EMA, based in Amsterdam, issues certificates for centrally authorised medicines. See our guide to the CoPP and our documentation and quality pack.
Supplements
Food supplements are sold as foods under the Commodities Act decrees on food supplements and herbal preparations, which set permitted vitamins and minerals, maximum amounts and label rules. The NVWA supervises the market, and some herbs are banned. Medical claims are not allowed, 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 the Netherlands search for
Semrush data from October 2026 shows that people in the Netherlands search most for creatine (about 60,500 searches a month), vitamin D (“vitamine d”) and magnesium (49,500 each), vitamin B12 (“vitamine b12”, 33,100), ashwagandha and omega-3 (27,100 each).
Dutch searchers mostly use generic names: “amlodipine” (about 7,540 searches a month), “ibuprofen” (7,390), “omeprazol” (7,140), “diclofenac” (6,970) and “naproxen” (6,500).
How importers, pharmacies and manufacturers in the Netherlands search
“private label” gets about 1,000 searches a month and “private label mfg” about 480. The Dutch “private label producenten” (private label producers) gets about 210.
Originator brands searched by name include Ozempic (semaglutide). 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 semaglutide, amlodipine, ibuprofen and omeprazole. Some examples we list:
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 the Netherlands?
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