Regulatory issues

- including marketing regulations

Legislation in the field of pharmaceuticals and related areas is changing rapidly as a result of EU regulation. This presents special challenges for businesses in relation to the marketing of new products, in particular in the grey areas between pharmaceuticals/medical devices, pharmaceuticals/foods and pharmaceuticals/cosmetics.

Other related issues involve the setting up, approval and running of clinical tests, the drafting of confidentiality agreements, experimentation agreements, patient consent for clinical tests, etc., and obtaining approvals from all relevant authorities.

The further stages introduce the process of applying for and obtaining marketing authorisation for pharmaceuticals. Finally, advertising for pharmaceuticals is governed by a complex regulatory regime.

Our expertise

Kromann Reumert has in-depth knowledge of Danish and EU regulation within these areas.