Adaptation of the Guidance document Authorisation ofHomeopathics, anthroposophics and othercomplementary medicinal products HMV4

30.04.2019

Declaration requirements modified for homeopathics and anthroposophics in the following sections.

Section 5.6.1.1 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