The Danish Health and Medicines Authority reminds companies submitting parallel import applications to enclose the package leaflet and labelling on an A4 sheet in a readable font size. The font size used must be size 11 or more.
Likewise, the proposed text for inner and outer labelling should be submitted on an A4 sheet in font size 11 or more. If companies intend to submit the proposed labelling as a scan of the packaging material, we require that it is a high-quality scan, enabling us to assess the labelling.
Companies that submit the proposed labelling as scanned documents are requested to also enclose a document which reproduces the proposed labelling text, so that it appears clearly which text will be used on the packaging material.
Furthermore, we encourage companies to submit the proposed package leaflet and labelling electronically (CD-ROM or DVD). This also applies if companies submit the labelling as scanned documents, either fully or partly.
We prefer to receive the package leaflet in Word format, and, if possible, also the labelling.
