Application deadlines in 2018

06 December 2018

The Danish Medicines Agency will be closed between Christmas and New Year from 22 December 2018 to 1 January 2019, both days inclusive.

This means that enquiries made to the Danish Medicines Agency, with a few exceptions, will not be read and replied during this period.

On this page, you can find the deadlines that apply to applications in the Danish Medicines Agency's area in 2018.

Application deadlines in 2018

Compassionate use permits on weekdays over Christmas and New Year

The Danish Medicines Agency will be reviewing urgent applications for compassionate use (applications for the dispensing of medicines not marketed in Denmark) on weekdays between Christmas and New Year.

Doctors, dentists or veterinarians can submit applications electronically through the website of the Danish Medicines Agency or by fax to +45 4488 9117, marking the application URGENT.

We will also answer questions about compassionate use permits on +45 4488 9536 on 27 and 28 December 2018 from 10:00 to 15:00.

 

Deadline for applications for export certificates for medicines in 2018

The final deadline for applications for export certificates for medicines is 11 December 2018.

Any certificates we receive from 11 December to 20 December 2018 will be dispatched on 21 December 2018 at the latest.

Any certificates we receive on 21 December 2018 by 11:00 will be dispatched on 21 December 2018. Certificates received after 11:00 will be considered received on 27 December 2018 and will not be dealt with before 7 January 2019.

We will not be handling certificates on 2, 3, and 4 January 2019.

 

Deadline for clinical investigation of medical devices in 2018

The final deadline in 2018 for the receipt of applications for authorisation of clinical investigations of medical devices is 14 December 2018.

Any applications received after this date will be considered received on 2 January 2019.

 

Deadline for applications for export certificates for medical devices in 2018

The final deadline for applications for export certificates for medical devices is 17 December 2018.

Any applications received after this date will be considered received on 2 January 2019.

 

Deadline for applications for clinical trials of medicines in 2018

The final deadline in 2018 for the receipt of applications for authorisation of clinical trials is 19 December 2018.

All applications that we receive after this date will be considered received on 2 January 2019.

 

Deadline for applications for marketing authorisations for medicines in 2018

The final deadline in 2018 for the receipt of applications for medicines is 19 December 2018.

All applications that we receive after this date will be considered received on 2 January 2019.

 

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