The following changes have been made to the information sheet with regard to preparations or groups of preparations that are currently classified as non-standardised medicinal products according to Art. 9 para. 2 let. e TPA:
- In sections 2 and 3.2, the preparations “platelet-rich plasma” and “platelet-rich fibrinogen” have been replaced by the preparation group “platelet products for autologous or allogenic use”.
- In section 2, additions have been made to the legal provisions for preparations with a purely cosmetic purpose included in the list according to Annex 3 TPLO.
- In section 4, information has been added regarding the establishment licence for manufacturing and distribution of non-standardised medicinal products.
The revised information sheet is valid with effect from 01 July 2024.