Application for exemption from labelling requirements, implementation deadlines, package leaflets etc.

Contact information

If applicable; building, door number, floor etc.

Uploaded Files

The application concerns exemption regarding

Uploaded Files

Uploaded Files

Uploaded Files

Uploaded Files

Uploaded Files

Uploaded Files

Information on the medicinal product:

Please fill in the requested information on the medicinal product below

Is the medicinal product restricted to hospitals?
Has the medicinal product been QP released?

Supply Difficulties:

Does the application concern a shortage situation?
Has the shortage been reported to the Danish Medicines Agency?

Additional information:

Uploaded Files

To expedite the processing of your application, please ensure that all relevant information is provided and the necessary attachments are included before submitting the application.

Hvis ansøgningen vedrører forsyningsvanskeligheder bedes I vurdere, om forsyningsvanskeligheden skal indrapporteres til Lægemiddelstyrelsen jf. Indberetningspligt ved forsyningsvanskeligheder med lægemidler

If the application concerns supply difficulties, please assess whether the supply issue should be reported to the Danish Medicines Agency in accordance with the Notification duty in the event of medicines supply shortages