Guidelines for application for a parallel import marketing authorisation of an already authorised medicinal product

If you want to submit a parallel import application, you must use a special application form.

Please note that you need to fill in one form per pharmaceutical form and strength for each country from which you wish to import the medicinal product.

When we receive your application, we check that your application includes the following:

1. A filled in application form.
2. Draft labelling of outer packaging in the current QRD template.
3. Draft labelling of inner packaging in the current QRD template.
4. Draft package leaflet in the current QRD template.
5. One copy of a specimen package from the export country, bearing the applicant’s name, the date of application and the export country.
6. Description of the repackaging, stating, among other things, whether the foreign outer packaging will be maintained or whether it will be replaced by the parallel importer’s own outer packaging.
7. Transport description in cases where the parallel imported medicinal product requires special storage conditions.

The applicant must keep a copy of the material submitted. The Danish Medicines Agency may request to see this copy, if relevant.

If the application contains the requested information, we will confirm receipt of your application within 14 days from the date of receipt.

If the application does not contain the requested information, we will write to you and ask you to submit the missing information within 14 days. Otherwise, we will return your application.

Application form for a parallel import marketing authorisation of an already authorised medicinal product (in Danish only)

Please submit the application to:

Danish Medicines Agency
Medicines Licensing
Axel Heides Gade 1
DK-2300 Copenhagen S

Tel. +45 44 88 95 95

If you have any questions regarding parallel import, please call us on the above phone number.