News - Marketing authorisation medicines for human use
36 news items Marketing authorisation medicines for human use
Brexit: Notification by the European Commission/EMA/CMDh and CMDv about Brexit and EU rules for batch control of medicinal products
On 25 February 2019 the European Commission (EC) published a notice on the European rules for batch control testing of medicinal ...
MEB fee rate change as of January 2019
The Medicines Evaluation Board (MEB) is increasing the fee rates for authorisation applications, authorisation changes and the ...
Year-end withdrawals
Requests for withdrawal on December 31st (the year-end withdrawals) should be received by the Medicines Evaluation Board (MEB) on ...
Information about the Falsified Medicines Directive (FMD)
Update for marketing authorisation holders The Falsified Medicines Directive (FMD) (Directive 2011/62/EU) are measures to prevent ...
Amended policy for DHPCs and national implementation of additional risk minimisation measures
The Medicines Evaluation Board (MEB) has amended its policy for Direct Healthcare Professional Communications (DHPCs) and the ...
Signal management pilot for limited group of companies
On 22 February 2018 a pilot will start for companies with medicinal products under additional monitoring. As from that date ...
National policy for labelling of medicinal products amended
The MEB has adapted the policy on labelling of medicinal products for human use. Information on this policy is contained in ...
The MEB is preparing for Brexit
The United Kingdom has decided to leave the European Union. This has consequences for the regulation of medicines in Europe. The ...
Safety features protect consumers against falsified medicines
From 9 February 2019 onwards, the packaging of prescription-only medicinal products must have safety features to protect ...
EudraVigilance not available for 10 days starting 8 November 2017
The new EudraVigilance system for the reporting and analysis of suspected adverse reactions (ADRs) to medicinal products, will ...