News - Marketing authorisation medicines for human use
19 news items Marketing authorisation medicines for human use
All MEB correspondence on human medicines will in future be sent by email
From 1 July 2022, all correspondence from the Medicines Evaluation Board on human medicines will be sent by email. Correspondence ...
Amended policy on national implementation of additional risk minimisation measures
The Medicines Evaluation Board (MEB) has amended its policy for the national implementation of additional risk minimisation ...
Medicines available faster due to simultaneous assessment
The National Health Care Institute joined forces with the Medicines Evaluation Board to develop a method that would give patients ...
Improvements to the notification process and form now available
In December 2021 the Medicines Evaluation Board and the Health and Youth Care Inspectorate announced the introduction of changes ...
MEB fee rate change as of January 2022
The Medicines Evaluation Board (MEB) increases the fee rates for authorisation applications, authorisation changes and the annual ...
Changes to policy on product information
The Medicines Evaluation Board (MEB) has recently revised two policy documents for pharmaceutical companies in respect of the ...
New reporting process for the Medicine Shortages and Defects Notification Centre
With effect from 1 January 2022, the Medicines Evaluation Board and the Health and Youth Care Inspectorate will be introducing ...
Medicine shortages and defects notification centre form improved
The notification form of the Medicine Shortages and Defects Notification Centre has been made more user-friendly. Various ...
Year-end withdrawals medicines for human use
Requests to withdraw marketing authorisations and parallel import marketing authorisations as of 31 December 2021, the so-called ...
Medical Devices Regulation: additional information about the procedure for medical devices
The date of application of the Medical Devices Regulation (MDR, EU 2017/745) is getting closer. In order to estimate the workload ...