News - Marketing authorisation medicines for human use

34 news items Marketing authorisation medicines for human use

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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 ...

News item | 11-12-2018 | 09:00

Year-end withdrawals

Requests for withdrawal on December 31st (the year-end withdrawals) should be received by the Medicines Evaluation Board (MEB) on ...

News item | 16-10-2018 | 16:00

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 ...

News item | 13-07-2018 | 08:00

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 ...

News item | 11-06-2018 | 15:00

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 ...

News item | 18-12-2017 | 14:00

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 ...

News item | 30-10-2017 | 15:00

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 ...

News item | 05-10-2017 | 14:00

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 ...

News item | 04-10-2017 | 15:00

Last call for marketing authorisation holders to submit information about in-use shelf life of OTC medicinal products

Marketing authorisation holders are obliged to include information about the in-use shelf-life of OTC medicinal products in the ...

News item | 13-09-2017 | 10:00

Assessment criteria for combination packages policy established

The Medicines Evaluation Board (MEB) has described the terms and conditions which are to be used to assess applications for ...

News item | 15-06-2017 | 15:00