medicinal products

Before a medicine can be marketed in the Netherlands, it must receive an authorisation (also called a marketing authorisation) from the MEB. Authorised medicines are medicines approved by the MEB. These medicines aelso carry risks or adverse effects.

The MEB determines whether the advantages of using the medicine have been proven to outweigh the risks – the so-called efficacy-safety balance. If the advantages outweigh the disadvantages, the medicine receives marketing authorisation. The MEB closely examines the efficacy, risks and quality of the medicine.

All important information about the medicine is reproduced in the detailed product information sheet for doctors and pharmacists (summary of product characteristics, SPC). A summary for patients is also made, in the form of a package leaflet. The MEB evaluates both extensive product information and the package leaflet. The MEB also decides on the product's legal status (whether it can be obtained without prescription or may only be dispensed on prescription). Once a medicine has been marketed, the MEB continues to monitor the medicine adverse event reports. It therefore always contains the most up-to-date information about the efficacy and possible adverse events of medicines. If necessary, the MEB can take steps like modifying the package leaflet text or - in the most extreme case - suspending sales or even withdrawing the medicine from the market entirely.

A manufacturer can request marketing authorisation for a medicine in one country or in several countries at the same time. To obtain a national marketing authorisation from the MEB, the manufacturer follows a national recognition procedure or a mutual recognition procedure. To obtain a European marketing authorisation, the manufacturer follows a decentralised or a centralised procedure via the European Medicines Agency, the EMA.