Hoe bereikt een nieuw geneesmiddel de patiënt?

Translated title of the contribution: How does a new medicine reach the patient?

B J Visser, D A Korevaar, M M Mokhles, W Vermeer-Pragt, A de Boer, T J Giezen

Research output: Contribution to journalA1: Web of Science-articlepeer-review

Abstract

The Medicines Evaluation Board (MEB) grants market authorisation for medicinal products in the Netherlands. The European Medicines Agency (EMA) coordinates the evaluation and safeguarding of medicinal products in the European Union. The core task of the MEB is to evaluate the quality of every medicinal product for which marketing authorisation is applied for by the manufacturer, and to assess the risk - efficacy balance of the product concerned. There are three different procedures that a manufacturer can follow: (a) the national procedure; (b) the decentralised procedure or mutual recognition procedure; (c) the centralised procedure. After marketing authorisation has been granted, the MEB ensures pharmacovigilance in cooperation with partners such as the Netherlands Pharmacovigilance Centre (Lareb). The MEB determines the text of the package leaflet, the packaging and the Summary of Product Characteristics (SmPC). The MEB checks the warnings that are sent out by manufacturers if important new information about a medicinal product becomes available.

Translated title of the contributionHow does a new medicine reach the patient?
Original languageDutch
Article number4859
JournalNederlands Tijdschrift voor Geneeskunde
Volume164
ISSN0028-2162
Publication statusPublished - 2020

Fingerprint

Dive into the research topics of 'How does a new medicine reach the patient?'. Together they form a unique fingerprint.

Cite this