SE Schweden
  • C10P - Pharmazeutische Produkte

Human medicinal products that are subject to parallel imports, see further in the impact assessment and regulations.

Swedish Medical Products Agency’s regulations (HSLF-FS 2021:xx) on parallel imported human medicinal products

Requirements concerning the parallel import procedure of human medicinal products, e.g. labelling and package leaflet, as well as the procedure for granting authorisation to sell a human medicinal product that is subject to parallel import.

The requirements on human medicinal products that are parallel imported and presented in the regulations are largely a codification of the EU Court of Justice’s case-law. The requirements that are set, including labelling and package leaflet, are deemed necessary to protect people’s lives and health.