News - Marketing authorisation medicines for human use

1. 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

2. 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

3. 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

4. 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

5. 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 ...

   News item | 21-01-2022 | 17:00

6. 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 ...

   News item | 03-01-2022 | 10:00

7. Changes to policy on product information

   The Medicines Evaluation Board (MEB) has recently revised two policy documents for pharmaceutical companies in respect of the ...

   News item | 16-12-2021 | 10:00

8. 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 ...

   News item | 01-12-2021 | 10:00

9. 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 ...

   News item | 01-10-2021 | 13:00

10. 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 ...

    News item | 24-09-2021 | 13:00