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

URLAutofill

Contact information

Company name:

Name of contact person:

Email address:

Phone number:

Adress:

Adress 2: If applicable; building, door number, floor etc.

Postal code and City:

Country:

If the application is submitted by someone other than the MA-holder or their representative, a power of attorney must be attached

Uploaded Files

The application concerns exemption regarding

Temporary sale of foreign packages
Error in the printed packaging material
Extension of the implementation deadline or failure to implement information/changes in the packaging material as a result of a variation application
Extension of an exemption previously granted by the Danish Medicines Agency
Previous decision or approval from the Danish Medicines Agency
Other

Specify language on the package:

Specify the differences between the packaging material of the foreign packs and the Danish packs:

State the background and justification for the application, including a description of the measures the applicant has taken to prevent a similar situation from occurring again:

Please state if there are any consequences for patient safety in case an exemption is granted:

Copy of the relevant packaging materials/mock-ups, including the package leaflet: Attach document(s)

Uploaded Files

Describe the error on the packaging material:

State the background and justification for the application, including a description of the measures the applicant has taken to prevent a similar situation from occurring again:

Specify any consequences the error has on patient safety and in the distribution chain in case this is affected:

Copy of the defective packaging materials: Attach document(s)

Uploaded Files

State the background and justification for the application, including a description of the measures the applicant has taken to prevent a similar situation from occurring again:

Specify the differences between the current package leaflet in the packs and the most recently approved version:

Specify any consequences an exemption may pose to the patient safety in case this is considered affected:

Attach a copy of the tracked patient information leaflet (PIL) and a copy of the decision from the Danish Medicines Agency that has led to the application for exemption

Uploaded Files

State the previous case number:

Provide a justification for why it is necessary to extend the exemption:

Attach previous decision:

Uploaded Files

State the previous case number:

Describe the reason for the application:

Attach a copy of the decision:

Uploaded Files

State the background and justification for the application, including a description of the measures the applicant has taken to prevent a similar situation from occurring again:

Specify any consequences an exemption may pose to the patient safety in case this is considered affected:

Attach any documents relevant for the application:

Uploaded Files

Information on the medicinal product:

Please fill in the requested information on the medicinal product below

Medicinal product name:

Pharmaceutical form:

Strength:

MA number:

Marketing authorization holder or representative:

Product number (Vnr):

Number of packages:

Expected duration of the exemption:

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:

Additional information considered relevant for the processing of the application:

Please attach any other documents considered relevant for the processing of the application:

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

Se i øvrigt vejledning på hjemmesiden: Dispensation fra krav om mærkning, implementeringsfrister indlægsseddel, mv. for 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

See also the guidance on the website: Exemption from the requirements for labelling, implementation deadlines, package leaflets etc. for medicinal products

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