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 must instead, prior to an application, indicate a realistic date to the Danish Medicines Council for when they wish to submit their application, and based on the applicant's wishes and available specialised committee meetings, the secretariat of the Danish Medicines Council determines an agreed application date together with the company.

The Danish Medicines Council's introduction of agreed application dates is part of a decision by the Danish Regions to reduce the processing time for assessments of new medicines and improve the working environment. The measure is intended to ensure more efficient case handling processes and allow the Danish Medicines Council to organise the further process for the assessments. This also means that pharmaceutical companies will receive a timetable for the assessment of their medicinal product in advance, as well as a date for when the Danish Medicines Council will decide on the application.

From 1 April 2024, the Danish...