Medicines without marketing authorization
The Dutch Medicines Act (Geneesmiddelenwet, GnW) prohibits the sale, distribution or supply of any pharmaceutical product (medicine) which has not been registered and granted a marketing authorization in the Netherlands. However, the Act also provides for a number of exceptions in specific circumstances, which are described in Article 40 of the Act.
In short, the exceptions mentioned are:
- Collegial delivery of pharmacy compounded medicinal products
- Compassionate use
- Supply of medicines to a Doctor’s Declaration
The information on this page mainly concerns the supply of medicines further to a Doctor’s Declaration under Article 40, paragraph 3c of the Act. Anyone wishing to supply an unregistered product further to a Doctor’s Declaration must first obtain permission to do so from the Health Care Inspectorate (IGZ). Permission will be granted only if a qualified medical practitioner determines that it is not possible to provide the treatment required by a patient using alternative, registered medicines which are readily available in the Netherlands. The medical practitioner must provide a written statement – known as a Doctor’s Declaration (artsenverklaring) – to this effect.
The Inspectorate will carefully assess each application, whereupon permission to supply the unregistered product will be either granted, dismissed for substantive reasons, or declined on procedural grounds. The assessment criteria and procedures are set out in Article 3.17 of the Medicines Act Regulation (Regeling Geneesmiddelenwet, RGnW), which accompanies and underpins the Act itself. In each case, the Inspectorate will assess whether all conditions stated in the article have been met in full. The Inspectorate is authorized to impose corrective measures if this is not the case.
- An unregistered pharmaceutical product may only be supplied if a qualified medical practitioner considers it essential to a patient’s treatment. A separate Doctor’s Declaration must be submitted for each individual patient.
- A ‘supplier’ (manufacturer, wholesale distributor, pharmacist, or general practitioner owning a pharmacy) wishing to supply an unregistered product further to a Doctor’s Declaration must apply to the Inspectorate for permission to do so.
- There must be no other registered product available in the Netherlands that can serve as adequate alternative medication. Sufficient documentation must be provided to substantiate that this is the case.
- The GMP status of the manufacturer is assessed by the Inspectorate.
- The product information for the unregistered product is assessed by the Inspectorate.
- The supplier must keep full administrative records, which must specify the quantity of the product supplied, the name of the prescribing doctor, the number of patients using the product, and details of any reported side effects.
How to request permission
- A supplier (manufacturer, wholesale distributor, pharmacist, or general practitioner owning a pharmacy) seeking permission to supply an unregistered pharmaceutical product must use the standard digital application form (in Dutch). A separate Doctor’s Declaration (Word file, 101 kB) must be submitted for each product. The application form must be accompanied by documentary evidence to support the safety and therapeutic necessity of the product. The absence of any registered alternative medicine must also be established. For further information, please refer to the Frequently Asked Questions section (which you should read carefully before submitting your application).
- If you submit your request using the standard digital application form, you will automatically receive immediate confirmation of receipt. If you submit your request by e-mail, post or fax, you will receive confirmation of receipt by e-mail within one week. If the Inspectorate considers the information provided to be insufficient to support a thorough assessment, you will receive an e-mail requesting you to provide additional details.
- Is your application urgent in nature? The Inspectorate is required by law to process your request within eight weeks, although we aim to process all requests as quickly as possible. If the unregistered product needs to be administered or supplied in the very short term, you may indicate the urgency of your request in the digital application form. In that case the Inspectorate will assign priority to your application.
- If your application is successful (i.e. the Inspectorate grants permission for the supply of the pharmaceutical product after assessing all relevant information), you will receive written notification within eight weeks.
- If your application is rejected, you may not supply the unregistered product to any third party. You will be notified of this decision and the grounds for refusal within eight weeks. If you nevertheless supply the product, you will be in violation of the Medicines Act, whereupon the Inspectorate may take appropriate action.
- The Inspectorate may also decline your request on procedural grounds, e.g. because the pharmaceutical product should be supplied according to the procedures of a Compassionate Use Programme regulated by the Medicines Evaluation Board (MEB).