News - Marketing authorisation medicines for human use

49 news items Marketing authorisation medicines for human use

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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 ...

News item | 26-10-2017 | 12:00

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

New legal EudraVigilance obligations as of 22 November 2017

As of 22 November 2017 new obligations in respect of signal management and reporting of suspected adverse reactions (ADRs) will ...

News item | 06-06-2017 | 13:00

MEB starts technical validation of electronic submissions as from 1 June 2017

Submissions concerning human medicinal products must be submitted electronically to the Medicines Evaluation Board (MEB). As from ...

News item | 29-05-2017 | 12:00

Confirmation of names for influenza strains

The Medicines Evaluation Board (MEB) has confirmed the Dutch translation for the active substances for influenza strains for the ...

News item | 08-05-2017 | 11:00

Health Care Inspectorate (IGZ) request to marketing authorisation holders: questionnaire for pharmacovigilance

The Dutch Health Care Inspectorate (IGZ) has developed a risk model for pharmacovigilance to obtain more insight into the risks ...

News item | 18-04-2017 | 08:00

Policy for the national informed consent marketing authorisation application

A company that wants to apply for a marketing authorisation for a medicinal product that is identical to another product that is ...

News item | 14-04-2017 | 14:00