Adaptation of the Guidance document Authorisation ofHomeopathics, anthroposophics and othercomplementary medicinal products HMV4
ZL103_00_002e_WL Guidance document Authorisation for homeopathic and anthroposophic medicinal products and medicinal products for gemmotherapy without indication in the notification procedure HMV4 (PDF, 749 kB, 08.05.2019)
Declaration requirements modified for homeopathics and anthroposophics in the following sections.
Section 188.8.131.52 General requirements relating to the dosage instruction in the product information
Section 5.3 Requirements relating to the declaration a) Full declaration form; b) Folding carton and Patient information
Section 7.2.3 Information and text on containers and packaging materials
The new version of the affected document enter into force as of 30.04.2019