In the Netherlands, medicinal products can obtain marketing authorisation via a national procedure. Besides the national procedure, there is also a European route to marketing authorisation valid throughout the European Union. This route is referred to as the Centralised procedure.
Here, marketing authorisations are granted under the responsibility of the European Commission. The main advantage of this procedure is that new, innovative medicinal products can be made available to all European residents at the same time once marketing authorisation has been granted. The Centralised procedure also leads to greater efficiency in Europe, as only one or two Member States are asked to produce assessment reports for each medicinal product.
Pharmaceutical companies that wish to follow the centralised procedure submit a dossier to the European Medicines Agency (EMA). The dossier is assessed by the Committee for Medicinal Products for Human Use (CHMP), the EMA's medicines assessment committee.
The CHMP has in principle 210 days to reach a final decision. This period may be suspended to allow the company to answer questions. Companies can also give verbal explanations relating to the dossier they have submitted. The CHMP produces an opinion which is sent to the European Commission and used in reaching the final decision. The European Commission usually adopts the CHMP's opinion in all respects.
Once a favourable decision has been made, the Summary of Product Characteristics (SmPC) and the package leaflet are determined. A European Public Assessment Report (EPAR) is produced. If the opinion is negative, information is given as to the grounds on which this conclusion was reached. The EPAR can be found on the EMA website.
Products that have obtained marketing authorisation via the Centralised procedure are given a European marketing authorisation number. Certain products must undergo the Centralised procedure: medicinal products that have been made using biotechnology, and new medicinal products intended to treat i.a. cancer, AIDS, neurodegenerative diseases and diabetes. In the case of other innovative products, companies are free to opt for either Centralised or National registration.
EMA and CHMP
The EMA receives applications under the Centralised procedure and controls the assessment process. The CHMP submits an opinion to the European Commission which then reaches a binding decision. Each European Member State has one representative on the CHMP and one alternate.
Two rapporteurs are appointed in the CHMP for each medicinal product, and they monitor the product throughout its life cycle. CHMP members operate in their personal capacity. They act as a bridge between the European system and national systems. In the Netherlands, the Dutch CHMP members report to the MEB.