News - Marketing authorisation medicines for human use
19 news items Marketing authorisation medicines for human use
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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 ...
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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 ...
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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 ...
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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 ...
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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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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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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 ...
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Medical Devices Regulation: additional information about the procedure for medical devices
The date of application of the Medical Devices Regulation (MDR, EU 2017/745) is getting closer. In order to estimate the workload ...