News - Marketing authorisation medicines for human use

41 news items Marketing authorisation medicines for human use

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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

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. ...

News item | 15-02-2017 | 14:00

Start of Medicine shortages and defects notification centre

Today, the Medicine shortages and defects notification centre has been launched. The notification centre is located at the ...

News item | 02-01-2017 | 12:00

Stricter requirements on the packaging of medicinal products to prevent falsification

The packaging of certain medicinal products for human use must have safety features implemented before 9 February 2019. This is ...

News item | 15-12-2016 | 16:30

Additional instructions for in-use shelf life OTC medicinal products

The Medicines Evaluation Board (MEB) is requesting manufacturers of multidose medicinal products that do not require a ...

News item | 23-11-2016 | 11:30

In-use shelf life to be listed on packaging of over-the-counter medicinal products

The Medicines Evaluation Board (MEB) wants manufacturers of over-the-counter medicinal products to list the in-use shelf life on ...

News item | 30-09-2016 | 10:30

Start of European registration of PSURs

All PSURS for centrally and nationally authorised medicinal products in Europe must be submitted via the PSUR Repository as of 13 ...

News item | 08-07-2016 | 15:00

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 | 14-04-2016 | 12:00

PSUR Repository has entered 'switch-on' phase

The PSUR-repository is the single, central platform to be used by all regulatory authorities and pharmaceutical companies in the ...

News item | 01-04-2016 | 10:00