organisation around medicines

Medicines are never entirely free of risk. To reduce the risk as much as possible, several different organisations examine a medicine closely. It may only be marketed after passing this examination.

The Medicines Evaluation Board assesses and authorises medicines and determines whether they may be marketed. Prior to authorisation, the manufacturer of a medicine conducts extensive medical research on it. Subsequently, the MEB receives a dossier with all of the research data. Based on this, the MEB assesses the efficacy, risks and quality of the medicine. If the benefits (efficacy and quality) of the medicine outweigh the dangers (risks and adverse events), then the medicine may be used in the Netherlands. The MEB issues a trade licence for the medicine. This is called marketing authorisation.

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 application procedure or a mutual recognition procedure. To obtain a European marketing authorisation, the manufacturer follows a decentralised or centralised procedure via the European Medicines Agency, the EMA.

The assessment of medicines with a new active ingredient is done on the European level. The European Medicines Agency (EMA) was established to this end in 1995.  In the scientific committee of the EMA, the CHMP, all countries of the European Union are represented via the national assessment boards like the MEB. The CHMP presents a recommendation about a medicine to the European Commission. The European Commission then decides whether the medicine will be authorised.

After authorisation, the MEB continues to monitor the risks of the medicines. Extensive research is carried out before medicinal products reach the market. This means that most adverse events are known. But once a medicinal product has been brought on the market, it will be used by millions of patients throughout the world over time. It is often only at this stage that rare, patient-related adverse events come to light. The process of reporting, analysing and dealing with these previously unknown adverse events after a medicinal product has been placed on the market is known as pharmacovigilance. This is one of the MEB's tasks. For more information, see the web pages  Reporting adverse events and DHPCs. Reporting adverse events leads to new understanding of the effects of medicinal products that were not yet known when the product received marketing authorisation. In the Netherlands, the Dutch Pharmacovigilance Centre Lareb collects reports from doctors, pharmacists and patients. It performs this task on behalf of the MEB.

Marketing authorisation is not the same as reimbursement by health care insurers. This requires another assessment of the medicine. In the Netherlands this is done by the Health Care Insurance Board (IGZ). The Ministry of Public Health, Welfare and Sport has a time limit of three months to decide whether the product is eligible for reimbursement or not. For more information, see CVZ.