News - Latest

1. 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

2. 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

3. Veterinary Medicinal Products Regulation: QRD template, GMP certificates, OMS registration and EMA activities

   The entry into force of the Veterinary Medicinal Products Regulation ( Regulation (EU) 2019/6) on 28 January 2022 will result in ...

   News item | 24-11-2021 | 12:00

4. Newest issue of Regulatory Science Magazine

   Today we have published the latest edition of our online science magazine: Regulatory Science Magazine. This edition contains the ...

   News item | 12-10-2021 | 11:00

5. Veterinary Medicinal Products Regulation: link between EudraGMDP database and OMS

   A number of things are going to change in relation to the EudraGMDP database in the field of veterinary medicinal products. This ...

   News item | 07-10-2021 | 17:00

6. Veterinary Medicinal Products Unit Fees for 2022

   A lot of procedures are going to change as a consequence of the Veterinary Medicinal Products Regulation ( Regulation (EU) ...

   News item | 04-10-2021 | 12:30

7. 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

8. Veterinary pharmacovigilance: important change relating to the submission of reports of adverse events

   As a marketing authorisation holder you are obliged to submit reports of adverse events to the medicinal product authorities. ...

   News item | 30-09-2021 | 10:00

9. 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

10. SPC, label and package leaflet of veterinary medicinal products will change

    The rules about the appearance of an SPC, label or package leaflet for veterinary medicinal products will change on 28 January ...

    News item | 08-09-2021 | 14:00