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56 news items
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 ...
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 ...
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 ...
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 ...
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) ...
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 ...
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. ...
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 ...
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 ...