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Investigational medicinal product

Specific rules apply for medicines that are used in clinical research, for instance, regarding the labelling, the delivery and the handover. A summary is provided below.

What is an investigational medicinal product (IMP)?

A medicine for research is denoted internationally by the term ‘Investigational Medicinal Product’ (IMP). The Dutch Medical Research Involving Human Subjects Act (WMO) refers to an 'investigational medicinal product'. This is also the case in the Medicines Act. In practice, the term ‘study medication’ is also widely used.

The WMO defines an investigational medicinal product as:

  • the investigational medicinal product itself;
  • the placebo;
  • the product with which it is compared.

Do you use registered medicines in scientific research? And do you do this in a different way or in a different composition than for which they are registered? Even then they are investigational medicinal products. For example, medicines:

  • for another indication;
  • for another target group (e.g. children);
  • in another combination or form of administration (e.g. with a medical device).

This also applies to registered medicinal products that are used in research to obtain additional information about the licensed applications.

Please refer to the following documents for further information:

Investigational medicinal products from abroad

Do you want to import an investigational medicinal product from a country other than an EU member state, Norway, Iceland or Liechtenstein? Thus, from outside the European Economic Area? Then a manufacturer’s permit is required under the Medicines Act. A manufacturer's permit can be requested from Farmatec. Farmatec is part of the Central Information Unit on Healthcare Professions (CIBG); this is an executive arm that is part of the Ministry of Health, Welfare and Sport.

Manufacturing investigational medicinal products

A manufacturing authorisation is required for manufacturing operations related to an investigational medicinal product (see Article 18, paragraph 1 of the Medicines Act (in Dutch)).

Labelling requirements for an investigational medicinal product

Packaging or labelling a drug for research is a preparation operation. A manufacturer's permit is required for this (see Article 18, paragraph 1 of the Medicines Act). A manufacturer must inter alia ensure that the preparation of medicinal products complies with the Good Manufacturing Practice (GMP) guidelines. The requirements stated therein cover the minimum information that must be on the label of an investigational medicinal product.

Deviations from this are only permitted in exceptional cases. See Article 14 of Directive 2001/20/ECand Article 32 of Eudralex Volume 4, Annex 13. Examples include radioactive preparations in a syringe for injection that have just been ‘loaded’. You also need to add a sample label and a copy of the manufacturer's permit as part of the documentation for the MREC assessing the study for approval.

Delivering an investigational medicinal product

A manufacturer may only deliver an investigational medicinal product for research to pharmacists. These pharmacists must practice their profession in a pharmacy (Medicines Act, Article 61, second paragraph). It is therefore not possible for a manufacturer to supply an investigational medicinal product directly to e.g. a doctor or a researcher.

Dispensing an investigational medicinal product (IMP) to trial subjects

Only a pharmacist may apply a patient label to an investigational medicinal product and then hand it over to the patient. Assigning an investigational medicinal product to a named patient (by pharmacists who work in the institution) is deemed to be part of the preparation. An exception to the permit requirements has been included in the Medicines Act for that purpose (Article 18, paragraph 7).

It may only be handed over after a prescription has been received from the investigator. It is also possible that a pharmacist may hand over an investigational medicinal product to an investigator for administration to a test subject. The investigational medicinal product must already be assigned to a specific patient (the label must have a patient number) at the moment that it is handed over to the investigator.

In both cases, the investigator must be authorised to prescribe it. Those authorised are doctors, dentists or obstetricians (an obstetrician may also prescribe prescription-only medicinal products that are related to treatments in their area of expertise). Supplying an anonymous stock of an investigational medicinal product to an investigator is not permitted.

Prescription by a Nursing Specialist or Physician Assistant

Under certain conditions, a nursing specialist or physician assistant may prescribe prescription-only medicinal products (see Guideline for implementing reallocation of tasks). Conditions include that the actions must be routine in nature. In this context, see also the temporary decisions on the independent authorisation of nursing specialists and physician assistants). In medical and scientific research, the opinion of the inspectorate is that actions that are routine in nature will not generally be involved.

Legislation, guidelines and procedures for research into medicinal products

For more information about aspects including the manufacture, supply, storage and handing over of investigational medicinal products, please see: