The Danish Medicines Council Introduces Agreed Application Dates And A New Process For Validation Of Applications
| Published date | 26 March 2024 |
| Law Firm | Plesner |
| Author | Mette-Marie Buch Henrichsen and Emma Marie S'gaard |
From 1 April 2024, pharmaceutical companies must agree on an application date with the Danish Medicines Council's secretariat when they want an assessment of a new medicinal product. At the same time, the process for the secretariat's validation of the applications will change, as the Danish Medicines Council will perform a technical validation within the first 10 working days.
Agreed application dates
Until now, pharmaceutical companies have been able to submit applications for assessments of new medicines at any time and without taking into account scheduled council and specialised committee meetings. With the new model, companies...
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