Guidance on package leaflets and labelling when applying for a parallel import licence

When an application for a marketing authorisation for parallel import is submitted, a draft package leaflet and draft outer and inner labelling must be submitted as well. This follows from the Danish Medicines Agency's Guidelines on parallel import of medicinal products, chapter 2.

The package leaflet must be written in compliance with the summary of product characteristics, cf. the Executive order on the labelling etc. of medicinal products (in Danish only). It is therefore important that the submitted package leaflet is compliant with the last revised summary of product characteristics.

Indicate the applied summary of product characteristics

To ease our administrative procedures, we urge parallel importers to indicate in the application form (e-form) or in the cover letter submitted with the application for a parallel import licence the summary of product characteristics applied to update the package leaflet, including the date.

Highlight changes made to the package leaflet and labelling

Furthermore, we strongly urge parallel importers to highlight all changes made to the package leaflet and labelling for the second country, and any subsequent countries, as tracked changes, so it clearly appears which changes have been made compared to the last submitted package leaflet and labelling.

Parallel importers are responsible for continuous updates

The above does not change the parallel importer's responsibility to continuously ensure that the package leaflet and labelling are updated and comply with the last received summary of product characteristics.

If relevant, we also encourage parallel importers to indicate in the application form (e-form) or in the cover letter that the package leaflet and labelling have been updated in compliance with any comments received in previous marketing authorisations.