News - Marketing authorisation medicines for human use

41 news items Marketing authorisation medicines for human use

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No variation for change of QPPV and/or PSMF location

As of 1 February 2016, a change in the “Qualified Person responsible for PharmacoVigilance” (QPPV) or the location of the ...

News item | 07-03-2016 | 08:00

New policy on national implementation of DHPCs

The Medicines Evaluation Board (MEB) has adopted a policy for the national implementation of Direct Health Care Professional ...

News item | 14-12-2015 | 17:00

Shelf life of over-the-counter medicinal products after opening

There is currently a lot of media attention for the listing of the shelf life after opening of over-the-counter medicinal ...

News item | 10-12-2015 | 16:00

Changes in policy on nomenclature of medicinal products

The Medicines Evaluation Board (MEB) has completely revised the policy document on the nomenclature of medicinal products for ...

News item | 09-10-2015 | 13:00

Changes in policy on product information

The Medicines Evaluation Board (MEB) has recently revised a number of policy documents about the requirements regarding product ...

News item | 24-09-2015 | 10:00

Narrow-spectrum penicillin no longer available: concerning development

The Medicines Evaluation Board (MEB) deems it extremely concerning that the antibiotics Sodium Penicillin G 1,000,000 IU, Sodium ...

News item | 10-09-2015 | 00:00

Tightening up of duplex marketing authorisation policy per 1 september 2015

During the past 2 years, the Medicines Evaluation Board (MEB) has talked with firms about the question whether to cease or to ...

News item | 01-09-2015 | 14:00

MEB confirms current legal status of supply ibuprofen 200 mg

The Medicines Evaluation Board (MEB) has evaluated whether the recent European review of the adverse events on heart and blood ...

News item | 03-08-2015 | 00:00

Consequences eSubmission Roadmap as of 1 July 2015

A number of important steps have been implemented as of 1 July 2015 in line with the eSubmission Roadmap. As a result of this ...

News item | 03-07-2015 | 16:00

Revision of policy on parallel importation

The Medicines Evaluation Board (MEB) has confirmed a new version of the policy on parallel importation. This policy applies to ...

News item | 12-06-2015 | 00:00