The involvement of representatives from patient organisations in the assessment of patient information in applications for authorisation and indication extensions for human medicinal products was trialled in a pilot phase (2018–2020).
This involvement aimed to optimise patient information in terms of the clarity, retrievability, weighting and completeness of the information.
Owing to the positive experiences from the pilot phase, the decision has been made to give all applicants the option of involving patient organisations in the assessment of patient information in future, as required.
This will be possible for the following application types:
- New authorisation of human medicinal product with new active substances under the standard procedure (NA NAS)
- New authorisation of human medicinal product with new active substances under the fast-track procedure (NA NAS FTP)
- New authorisation of human medicinal product with new active substances under the procedure with prior notification (NA NAS PPN)
- Authorisation extensions involving revision of the medicinal product information (MPI), and
- Type II changes involving revision of the MPI or indication extensions.
The guidance document Involvement of patient organisation in assessment of patient information HMV4 sets out, among other things, the responsibilities and the procedure, and gives patient organisations further instructions on the criteria to be examined in the patient information.
Moreover, targeted training sessions for interested patient organisations are planned in the fourth quarter of 2021.
The new guidance document is valid with effect from 1 November 2021.