Legal basis for the Ordinary Revision of the TPA (Stage 2) and its right of enforcement

Therapeutic Products Ordinance Package IV

The revised implementing ordinances (Therapeutic Products Ordinance Package IV; TPO IV) comprises the ordinances both of the Federal Council and of the Swissmedic Agency Council. The Agency Council approved five ordinances on 7 September 2018. On 21 September 2018, the Federal Council passed resolutions on three additional ordinances.

On 1 January 2019 the revised Therapeutic Products Act (TPA 2) and the majority of the revised implementing ordinances (TPO IV) will enter into force.

TPO IV comprises the following ordinances of the Agency Council and Federal Council (these documents – available in German, French or Italian – are intended for information only and do not have legal force1):

Powers of the Swissmedic Agency Council to enact legislation

Powers of the Federal Council to enact legislation

The ordinances of the Federal Council can be found on the website of the Federal Office of Public Health (FOPH):


1Important information:

No official publication has yet been implemented either for the ordinances approved by the Agency Council on 7 September 2018 or for those approved by the Federal Council on 21 September 2018. The present publication of the texts is intended for information only and does not have legal force.

Moreover, the implementing provisions on the Medicrime convention which are currently being finalised and are also due to enter into force on 1 January 2019, necessitate a number of adjustments to the Therapeutic Products Ordinance (TPO), the Therapeutic Products Licensing Requirements Ordinance (TPLRO) and the Ordinance on the Simplified Licensing of Therapeutic Products by the Notification Procedure (TPLO).

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Total revision of the Ordinance on Licensing in the Medicinal Products Sector (MPLO)

At its 14 November 2018 meeting, the Federal Council approved the implementation on 1 January 2019 of the totally revised MPLO and of certain adjustments to the ordinances on medicines (VAM/OMéd/OM) and veterinary medicines (TAMV/OMédV/OMVet). This project of revision also entails certain amendments ensuing from the ordinary revision of the TPA, from the ratification by Switzerland of the Medicrime Convention of the Council of Europe as well as certain adaptations resulting from new knowledge gained in practice.

The ordinances of the Federal Council can be found on the website of the Federal Office of Public Health (FOPH):

Last modification 23.11.2018

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