The following forms, though designed for medicinal products, can also be used (subject to modification as required) for transplant products:
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
ZL104_00_002e_WL Guidance document Fast-track authorisation procedure HMV4 (PDF, 211 kB, 12.06.2019)
Procedure with prior notification TPO4
Temporary authorisation TPO4
Company meetings relating to authorisation TPO4
SwissPAR TPO4
Authorisation of TpP/GT/GMO with new active substance TPO4
Authorisation of TpP/GT/GMO with known active pharmaceutical substance 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