New rules on HCP relationships and economic support to HCPs come into force on 26 May 2021
The amendments to the rules on HCP relationships with companies and economic support to HCPs come into force on 26 May 2021. Among other things, the amended rules concern the group of comprised companies, the obligation to report economic support, and the obligation to make notifications or seek permission regarding HCP relationships.
The rules not only apply to companies holding a marketing or company authorisation, but also the Danish representatives of foreign pharmaceutical companies holding such an authorisation. Moreover, companies manufacturing, importing or distributing medical devices without an intended medical purpose are also comprised by the rules.
Under the rules, pharmaceutical and medico companies established in Denmark and the Danish representatives of foreign pharmaceutical companies holding marketing or company authorisations are obliged to notify the Danish Medicines Agency once a year about the HCPs with whom the company has a relationship, and 2) if providing economic support to participation in professional activities and conferences, the companies must report to the Danish Medicines Agency to which HCPs and competent professional individuals they have provided support.
This also entails changes to the rules on which activities require permission or notification, respectively.
You can read more about the amended rules in Plesner's previous insight. Plesner will stay updated on the rules and their application.
Read the new Executive Order on the advertising, etc., of medicinal products (in Danish).
Read the new Executive Order on the advertising, etc., of medical devices (in Danish).
Read the new Executive Order on pharmaceutical and medico companies', etc., relationships with HCPs (in Danish).
Read the amending act itself (in Danish).