As per the recent update from the Danish Medicines Agency (DMA) dated October 19, 2022, the deadline for submitting marketing authorization and clinical trial applications has been revised to December 20, 2022. The move comes as the DMA will be closed from December 24 to January 01, 2023, for the Holiday Season.

The applications must be submitted before the deadline to be considered by the DMA. For the applications submitted past the deadline, the date of receipt of the applications shall be considered as January 02, 2023. Applicants must be aware of a few other specifications, which are discussed below.

Clinical Trial Applications

Further to the deadline, applicants must know that the EU Clinical Trials Directive expires on January 31, 2023. The Directive applies to the clinical trials of medicinal products for human use. Post this date, all the applications have to be applied through the Clinical Trial Information System (CTIS).

Any amendments/modifications in the ongoing clinical trials are harmonized and streamlined throughout the EU with the CTIS. The new system brings in additional requirements for applications, deadlines, and communications with the Health Authorities. The Clinical Trials Regulation has taken several steps to encourage Good Clinical Practice (GCP), and the CTIS is one of the major steps in this direction.

Marketing Authorizations

The latest guidelines are for marketing authorizations and include variations, extensions, and follow-up cases. For variation and response applications, applicants must use the right attributes while updating the dossier. E.g., new, replace, or delete:

• New is to be used if the document is completely new
• Replace must be used when the application is made to replace an existing document, and
• Delete must be used when deleting a redundant document.

The guidelines also apply to Active Substance Master Files (ASMFs). The renewed DMA guidelines supplement the existing guidelines issued by the European Medicines Agency (EMA), the Co-ordination group for Mutual recognition and Decentralized procedures – veterinary (CMDv), and the Co-ordination group for Mutual recognition and Decentralized procedures – human (CMDh). They are relevant to applications submitted under the national procedure, Mutual Recognition Procedure (MRP), and the Decentralized Procedure (DCP).

Applicants must abide by the new deadlines to get approvals for their applications on time. It is also significant to ensure all the mandated regulations are always complied with while meeting the stringent timelines. A proven Regulatory partner like Freyr can help you with timely submissions to the DMA while maintaining compliance with the prevalent guidelines. Consult now.