The revised implementing ordinances (Therapeutic Products Ordinance Package IV) for the ordinary revision of the Therapeutic Products Act (TPA 2) will come into force on 1 January 2019. As a result of the revision, Swissmedic has adapted the documents for authorisation applications.
Documents/Forms under the new legislation (Submission as of 1.1.2019)
Valid of as 01.01.2019
For applications under the new legislation submitted before 1 January 2019, a submission date of 3 January 2019 will apply (start of deadline period).
Valid until 31.12.2018
Description of the document classes and types
Last modification 30.09.2018