News - Marketing authorisation medicines for human use

1. Planning tool for requesting time slots mandatory from 1 July 2025

   As of 1 July 2025 it will be mandatory to use the MEB planning tool to reserve a time slot for submitting an application for ...

   News item | 01-05-2025 | 12:00

2. European Shortages Monitoring Platform operational

   The European Shortages Monitoring Platform (ESMP) went live this week. The platform enables marketing authorisation holders and ...

   News item | 31-01-2025 | 13:00

3. MEB fee rate change as of January 2025

   The Medicines Evaluation Board (MEB) increases the fee rates for authorisation applications, authorisation changes and the annual ...

   News item | 01-01-2025 | 08:00

4. Revised notification form for medicine shortages and defects

   The notification form of the Medicine Shortages and Defects Notification Centre has been made more user-friendly. The marketing ...

   News item | 28-10-2024 | 10:00

5. Planning tool for requesting timeslots expanded to more procedures

   The planning tool firms can use to reserve a timeslot for requesting assessment procedures is being expanded. From now on, the ...

   News item | 16-01-2024 | 12:00

6. MEB fee rate change as of January 2024

   The Medicines Evaluation Board (MEB) increases the fee rates for authorisation applications, authorisation changes and the annual ...

   News item | 02-01-2024 | 11:00

7. Changes to fees for human medicinal products and devices as of 1 January 2023

   With effect from 1 January 2023, the Medicines Evaluation Board (MEB) will be increasing the fees for authorisation applications, ...

   News item | 02-01-2023 | 08:00

8. 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 ...

   News item | 24-06-2022 | 16:00

9. 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 ...

   News item | 30-03-2022 | 15:00

10. 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 ...

    News item | 22-02-2022 | 10:00