D4. Applicable statements and licenses
Information on medicinal products without marketing authorization can be found on the website of the Dutch Health and Youth Care Inspectorate. Here you can find information on the production, import, release and storage of research medication.
Production and import of research medication
An application for a licence for the manufacture or import can be submitted to the Farmatec Unit (in Dutch) of the Central Information Point for Professions in Healthcare (CIBG). The license application is compulsory for those who prepare, let prepare or import medicinal products. Import is the obtaining of medicinal products from outside the EER, the European Economic Area: The EU member states plus Norway, Iceland and Lichtenstein.
A manufacturing licence is also required for the preparation of medicinal products in the Netherlands. This applies to production, packaging and labeling of products. A manufacturing license gives the carrier the right to produce and export self-prepared and imported medicinal products.
Hospital pharmacies may only prepare research medicinal products if they have a valid licence. Preparation does not cover the following:
- preparing the product for administration;
- relabeling in accordance with a set randomization list. For example, if a hospital pharmacist receives batches of a placebo and and active product, prepares these for a research subject (for example, measuring the product according to body weight) and blinds the relabeling (by addition of a label with a code);
- relabeling due to extension of an expiration date on the product. This must be done in accordance with a written standard procedure including a quality control by a second competent person.
Release of research medication
A batch of a research medication may only be released by a Qualified Person (QP) given in the manufacturing license. The requirements which must be met by a QP are given in chapter 2 of the Medicine Law Regulation. (in Dutch)
Storage of research medication
Only hospital pharmacists and holders of a trading license may store medicinal products for use in research. If a Clinical Research Organisation (CRO) stores research medication in another manner than intended, then it is required to have a trading license. Research medicinal products may not be directly delivered by the trading licensee to the investigator or the patient. This falls under the responsibility of the hospital pharmacist.
Information regarding licences for research with genetically modified organisms is available from the Gene Therapy Office website. For studies with substances subject to the Opium Act, a grant exemption (in Dutch) is needed. This can be applied for at Farmatec.