Enquiries to the Danish Medicines Agency about the status of submitted applications for medicinal products approved via DCP, MRP or national procedure

The Danish Medicines Agency has set up a dedicated mailbox, status@dkma.dk, for enquiries about the status on the above mentioned applications.

It is important for the Danish Medicines Agency to be able to give a quick answer about the status of submitted applications. Inquiries sent to the mailbox, status@dkma.dk, will therefore be answered within two working days.

Which enquiries can be sent to the mailbox?

• Issue of marketing authorisation for medicinal products.
• Human variations (type II, IB, IA, groupings and worksharing) and article 61(3) notifications, where Denmark is the reference member state.
• Human variations (type II, IB, IA, groupings and worksharing) and article 61(3) notifications where Denmark is concerned member state and where there are changes to the product information.
• Veterinary variations (VRA and VNRA), where Denmark is the reference member state.
• Veterinary variations (VRA and VNRA), where Denmark is concerned member state and where there are changes to the product information.
• Renewal of the marketing authorisation, where Denmark is the reference member state.
• Review of educational material for medicinal products approved via DCP, MRP or national procedure.

We publish order books for national type IB variations and national type II variations awaiting to be initiated. We also publish a table showing the status of initiated procedures for national Type IB variations and type II variations.

Enquiries to our other mailboxes will still be answered as soon as possible.