Changes to the guidance document Temporary authorisation of human medicinal products
Clarification regarding authorised medicinal products, harmonised deadlines for applications before expiry of temporary authorisation and changes to terminology.
All criteria according to Art. 9a TPA in conjunction with Art. 18 TPLO must be met cumulatively for a temporary authorisation. According to the legal requirements for a temporary authorisation, there must be no alternative or equivalent medicinal product authorised in Switzerland in the indication applied for. Swissmedic considers the following to be “authorised”: 1) medicinal products that have been authorised in the procedure according to Art. 11 TPA with complete documentation, and 2) medicinal products that have been converted from a temporary authorisation to an authorisation with special conditions (completed documentation) according to Art. 21a para. 2 TPLO. Clarifications have been made accordingly in section 5.2 of the guidance document Temporary authorisation for human medicinal products.
In addition, the application deadlines for temporarily authorised medicinal products have been harmonised: Now, for example, a uniform deadline of a maximum of 90 calendar days before the temporary authorisation expires applies to removal of the conditions relating to temporary authorisation, extension of the temporary authorisation or waiver of a temporary authorisation.
The revised guidance document also now consistently uses the term “authorisation without special conditions” rather than the term “ordinary authorisation”.
The revised guidance document is valid with effect from 15 September 2023.
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