Monitoring the quality of medicines on the market is a continuous process. Prior to the market authorization, the quality assessment is based on the manufacturer's dossier. Given the stringent requirements for authorisation and the Good Manufacturing Practices, we assume that the quality of all registered medicines is in order. Before and/or after market authorization, research takes place. The aim is to verify the product’s quality.

Batch release of blood products and vaccines

For certain categories of medicinal products, namely vaccines and blood productsplasma-derived medicines, RIVM, as the competent authority, carries out a control for each batch of the medicinal product before it is authorized to enter the market. More information: Release of plasma-derived medicines and vaccines.

Control of medicines

RIVM checks the chemical quality of pharmaceuticals on behalf of the Health and Youth Inspectorate, IGJ. The main purpose is to check whether a medicinal product placed on the market meets the quality requirements as laid down by law. This includes the medicine’s appearance, its active ingredient content and the presence of impurities. Such information is recorded in the marketing authorisation dossiers or in the European Pharmacopoeia. Read more on Control of medicines.

European Pharmacopoeia

A pharmacopoeia is an officially issued digital manual containing directions for the preparation of medicinal products for humans and animals, and the requirements to be met. The purpose of the European Pharmacopoeia (Ph. Eur) is to ensure that medicines, whether for humans or animals, are safe and of good quality. In the Netherlands, the European Pharmacopoeia is law.

Illegal medicines

Illegal medicines, such as falsified medicines, are a global problem, and therefore also in the Netherlands. Laws, regulations and international cooperation seek to limit the scale of the problem. RIVM investigates (suspected) illegal medicines in the lab and participates in international working groups. You can learn more about it on Illegal medicines.