Applications and meetings TPO4
Fast-track application TPO4
ZL104_00_002e_WL Guidance document Fast-track authorisation procedure HMV4 (PDF, 214 kB, 16.07.2019)
Procedure with prior notification TPO4
Temporary authorisation TPO4
Company meetings relating to authorisation TPO4
New application TPO4
Authorisation human medicinal product under Art. 13 ATP TPO4
The Questions and answers regarding the application of the Administrative Ordinance (Art. 13, Therapeutic Products Act) are being revised; we will make the updated version available to you again as soon as we can.
Authorisation biosimilar TPO4
The Questions and answers on the authorisation of similar biological medicinal products (biosimilars) are being revised; we will make the updated version available to you again as soon as we can.