MEB 41: MEB policy concerning marketing authorisations without Dutch translations of the product information and/or mock-ups

The MEB is aware of the fact that medicinal products are not always marketed immediately after authorisation. Following the European decentralised or mutual recognition procedures (DCP/MRP), it is possible that medicinal products are authorised but subsequently not released on the Dutch market. Taking these facts into consideration, the MEB has decided to allow several exceptions regarding the Dutch translation of product information and mock-ups.