No established indications or dosages are approved for homeopathic and anthroposophic medicinal products without indication that are authorised in the notification procedure or on the basis of a reduced dossier. These medicinal products are used as directed by the advising professional as part of individual therapy according to the principles of the relevant school of therapy.
The requirements for the declaration of active substances and pharmaceutical excipients of human medicinal products (full declaration) according to Annex 3 and 3a TPLRO, which entered into force on 1 January 2019, also apply to homeopathic and anthroposophic medicinal products without indication based on Art. 12 para. 2 in conjunction with Annex 1a Section 1 para. 1 let. e TPLRO.
In the case of medicinal products without indications whose application for authorisation was submitted on or after 1 January 2019, the revised requirements for the declaration must be fulfilled at the time of first authorisation. In the case of medicinal products whose application for authorisation was submitted before 1 January 2019, the requirements must be implemented by one year after the official decision on unconditional authorisation at the latest.
To ensure the safety of medicinal products without indication that contain excipients of particular interest, the declaration and inclusion of the relevant warnings according to Annex 3a TPLRO should be carried out promptly. The intended standard, transparent declaration of excipients is essential in the benefit-risk assessment when dispensing medicinal products in individual therapy. Marketing authorisation holders are therefore requested to incorporate the relevant details of excipients of particular interest in the packaging for medicinal products whose last authorisation renewal is only scheduled for after 1 January 2024 on their own initiative by 31 December 2024 at the latest.
Explanations regarding implementation of the requirements, including dealing with no fixed dosages, are provided in the guidance documents Authorisation for homeopathic and anthroposophic medicinal products and medicinal products for gemmotherapy without indication in the notification procedure and Authorisation of homeopathics, anthroposophics and other complementary medicinal products.