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Regulatory Science Magazine 02

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...

15-06-2017 | 15:00

MEB Annual Report: a leading player in Europe again in 2016

The Medicines Evaluation Board (MEB) was one of the leading players in Europe in the field of medicine assessment and...

08-06-2017 | 09:00

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...

06-06-2017 | 13:00

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.

02-06-2017 | 10:00

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...

01-06-2017 | 14:00

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...

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...

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...

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...

14-04-2017 | 14:00

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...

20-03-2017 | 09:00

Retrospective MEB eDay 2017: Change in sight

In order to respond to e-developments, it is important that the information provision by the Medicines Evaluation Board (MEB)...

17-03-2017 | 15:00

Notification form medicine shortages and defects now also in English

As of today, the notification form of the Medicine shortages and defects notification centre is now also available in English....

15-02-2017 | 14:00

Science Day 2017 - Generic drugs in society: the regulator’s dilemma

Trust, costs, safety and proper information are the words that regularly recurred during the 6th Science Day of the Medicines...

13-02-2017 | 16:00

The Netherlands a candidate for future EMA location

The Netherlands has submitted its candidacy as the country of choice for housing the European Medicines Agency (EMA). The EMA...

17-01-2017 | 16:00

Santeon and MEB exchange information about prescription of medicinal products

In the coming year, the Medicines Evaluation Board (MEB) and hospitals affiliated with Santeon will exchange anonymous...

13-01-2017 | 10:00
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