Valid until 31.12.2022
Authorisations TpP/GT/GMO
Formal requirements TPO4
Product information and packaging TPO4
Time limits for authorisation applications TPO4
Applications and meetings TPO4
New application TPO4
Variations and extensions TPO4
Renewal and discontitnuation of authorisation on change status (main authorisation / export licence) TPO4
No marketing / interruption of distribution TPO4
Orphan drug application TPO4
Fast-track application TPO4
Procedure with prior notification TPO4
Temporary authorisation TPO4
Valid from 1 January 2023
Company meetings relating to authorisation TPO4
SwissPAR TPO4
Medicinal Product Names HMV4
Authorisation of TpP/GT/GMO with new active substance TPO4
Authorisation of TpP/GT/GMO with known active pharmaceutical substance TPO4
Fast-track authorisation procedure TPO4
Procedure with prior notification TPO4
Paediatric investigation plan TPO4
Document protection TPO4
Authorisation TpP/GT/GMO under Art. 13 ATP TPO4
Authorisation TpP/GT/GMO in accordance with Art. 14 para. 1 abis-quater TPA TPO4
Temporary authorisation for TpP/GT/GMO TPO4
Renewal of authorisation TPO4
QR restrictions after first authorisation TPO4
Valid until 31.12.2022
Valid from 1 January 2023
ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers (PDF, 266 kB, 24.05.2023)
ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers (PDF, 266 kB, 24.05.2023)