Medicinal products for human use

The Swedish Medical Products Agency’s regulations (HSLF-FS 2021:xx) on labelling and package leaflets of medicinal products for human use

The regulation governs the labelling of the packaging of medicinal products for human use and the presentation of the enclosed package leaflet.

Rules on the labelling of medicinal products for human use and the presentation of the package leaflet are set out in Directive 2001/83/EC. The national provisions proposed by the Swedish Medical Products Agency are deemed necessary to protect public health in Sweden. They are also considered proportionate.