Rules applicable to active substances (APIs)
Please note that this website has yet to be updated regarding the regulation (EU) 2019/6 on veterinary medicinal products. We refer to the Danish website for the updated information.
Active substances (APIs) that are used in the manufacture of human and veterinary medicines must be manufactured in compliance with the GMP rules.
This requirement applies to both manufacturers and importers of medicines from third countries (i.e. countries outside EU/EEA). API manufacturers as well as any intermediaries which portion, repackage, etc. must comply with the GMP rules.
The rules applicable to manufacture, import and distribution of active substances intended for the manufacture of human medicines are established in:
Please note that the Danish API order and the GDP guidelines only cover active substances intended for the manufacture of human medicine. Active substances intended for the manufacture of veterinary medicines are exempted from the API order and the guidelines.