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102 news items
2nd Edition of MEB Regulatory Science Magazine released
Today, the 2nd edition of the Regulatory Science Magazine was released. This online magazine, produced by the Medicines ...
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 ...
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 ...
Eric Boersma sworn in as new MEB Member
Mr Prof H. (Eric) Boersma was sworn in as a new member of the Medicines Evaluation Board (MEB) on 1 June 2017.
Anthonius (Ton) de Boer new MEB chairman
Prof. Ton de Boer is to take over as the new chairman of the Medicines Evaluation Board (MEB) as of 1 August 2017. This was ...
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 ...
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 ...
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 ...
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 ...
One step closer to less animal testing
In the future, a part of animal testing for new medicines will no longer be necessary. In most cases, testing on one species of ...