Regulatory matters

Companies in the pharmaceutical and biotech industries are regulated by a complex set of rules that comprise all phases from the start-up of companies to production, sale and marketing of the company's products.

The legal regulation is complex and is constantly evolving. In recent years European Community rules have also been increasingly harmonised, but regulatory matters in the individual Member States still differ and constitute a challenge in relation to the market strategic behaviour of the companies.

Market-leading experience

We have market-leading experience in providing advice on all regulatory matters, including national and European procedures for obtaining and granting marketing authorisations as well as thorough knowledge of rules and practice for data protection in relation to abridged applications.

Our focus areas

We provide strategic advice on a number of regulatory matters, including prices, substitution and subsidies. In addition to that, we have detailed knowledge of rules and practice in relation to access to documents in the public authorities' administrative files.

We also assist with all kinds of agreements, for instance clinical trial agreements, and we have extensive experience in providing advice in respect of the standards for good manufacturing practice (GMP) and good clinical practice (GCP).

Rules of advertising and sponsoring

We have extensive knowledge of the rules on advertising of pharmaceutical products and we assist a large number of companies in relation to the drafting of advertising and information material to ensure compliance with the comprehensive set of rules. We also have a unique knowledge of the Danish Medicines Agency's practice and the practice of the Danish Legal Board of Self-Regulation concerning Pharmaceuticals in relation to advertising of pharmaceutical products.

We also provide advice on collaboration agreements between pharmaceutical companies and healthcare professionals as well as matters relating to grants and sponsoring between pharmaceutical companies and hospitals/healthcare professionals.


© Plesner  TEL +45 33 12 11 33 - Amerika Plads 37 - 2100 Copenhagen - CVR 42 93 85 13