News - Marketing authorisation medicines for human use
40 news items Marketing authorisation medicines for human use
Changes to product information must be made more quickly
Within Europe agreements are regularly made regarding changes to information on medicinal products. In many cases it takes too ...
Year-end withdrawals medicines for human use
Withdrawal requests for (parallel) marketing authorisations per 31 December, the so-called 'year-end withdrawals' for medicines ...
MEB and ZIN start pilot to accelerate access to innovative medicines
Accelerating patient access to reimbursable innovative medicines has been on the wish list of the government, patient ...
Amended policy relating to patented indications
The Medicines Evaluation Board (MEB) will no longer publish the full product information about the active substance of generic ...
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 ...