As published in Swissmedic Journal 08/2024 on page 628 (in German) as well as pages 629 and 630 (French text), the word “entirely” can be deleted with immediate effect from the fixed text on the medicinal product's specified indication for complementary medicines.
The guidance document Product information for human medicinal products and the template Patient information for complementary medicinal products have been revised accordingly.
Other changes relating to complementary and herbal medicines and other editorial changes have also been made in the guidance document Product information for human medicinal products. For example, in the “Notes on the Information for healthcare professionals” section, the instructions on declaring herbal active substances have been deleted; these are now only in the guidance document Authorisation of herbal medicinal products.
In “Part B – Requirements for the Patient information for complementary medicinal products” of the guidance document Product information for human medicinal products, the validity of the instructions has been extended to all complementary medicinal products and all complementary medical therapies. The template Patient information for homeopathic and anthroposophic medicinal products has therefore been renamed Patient information for complementary medicinal products.
The guidance document Product information for human medicinal products and the template Patient information for complementary medicinal products enter into force from 15 November 2024.