The Danish Medicines Agency will be closed over Christmas and New Year, from 24 December 2015 to 3 January 2016 inclusive. We will not read faxes and post sent to the Danish Medicines Agency’s main fax number and address in this period.
Below you can find the Danish Medicines Agency’s deadlines for 2015:
Applications for compassionate use permits on weekdays between Christmas and New Year
Applications for export certificates for medicinal products: 14 December
Applications for clinical investigations of medical devices: 16 December
Applications for Certificates of Free Sale for medical devices: 16 December
Applications for marketing authorisations for medicinal products: 21 December
Applications for clinical trials: 21 December
Applications for compassionate use permits on weekdays between Christmas and New Year
The Danish Medicines Agency reviews urgent applications for compassionate use (application for the dispensing of medicines not marketed in Denmark) on workdays between Christmas and New Year.
Doctors, dentists and veterinarians can submit applications electronically via the Danish Medicines Agency’s website or by fax to +45 44 88 91 17. Please mark the application URGENT.
We will be taking calls about compassionate use permits on +45 44 88 95 36 on 28, 29 and 30 December 2015 from 10am to 3pm.
Deadline for applications for export certificates for medicinal products: 14 December
For applications that we receive no later than 14 December, we will issue the export certificates before Christmas.
For applications that we receive after 14 December but no later than 18 December, we will make efforts to issue the export certificates on 23 December at the latest.
For applications that we receive on or after 21 December, we will issue the export certificates after 4 January 2016.
Applications for export certificates for medicinal products
Deadline for applications for clinical investigations of medical devices: 16 December
Applications for clinical investigations of medical devices in 2015 must reach us by 16 December 2015.
All applications that we receive after this date will be considered received on 4 January 2016.
Applications for clinical investigations of medical devices
Deadline for applications for Certificates of Free Sale for medical devices: 16 December
Applications for Certificates for Free Sale for medical devices in 2015 must reach us by 16 December 2015.
All applications that we receive after this date will be considered received on 4 January 2016.
Applications for Certificates of Free Sale for medical devices
Deadline for applications for marketing authorisation of medicinal products: 21 December
Applications for marketing authorisation of medicinal products in 2015 must reach us by 21 December 2015.
All applications that we receive after this date will be considered received on 4 January 2016.
Applications for marketing authorisations for medicinal products
Deadline for clinical trial applications: 21 December
Applications for authorisation of clinical trials in 2015 must reach us by midday on Monday 21 December 2015.
All applications that we receive after this date will be considered received on 4 January 2016.
The deadline concerns companies and researchers that wish to apply for authorisation of clinical trials of medicinal products.
Applications for clinical trials