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