Legal basis for the Ordinary Revision of the TPA (Stage 2) and its right of enforcement
The modifications following the Ordinary Revision of the TPA and its right of enforcement as well as the legislative changes in connection with the implementation of the Medicrime Convention and of the total revision of the Ordinance on Licensing in the Medicinal Products Sector (MPLO) will enter into force on 1 January 2019.
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
Ordinances
- Ordinance on the requirements for the authorisation of medicinal products (PDF, 416 kB, 21.09.2018)Verordnung des Schweizerischen Heilmittelinstituts über die Anforderungen an die Zulassung von Arzneimitteln | Änderung vom 7. September 2018
- Ordinance on the simplified marketing authorisation of medicinal products (PDF, 172 kB, 21.09.2018)Verordnung des Schweizerischen Heilmittelinstituts über die vereinfachte Zulassung von Arzneimitteln und die Zulassung von Arzneimitteln im Meldeverfahren (VAZV) | Änderung vom 7. September 2018
- Complementary and Herbal Medicinal Products Ordinance (PDF, 238 kB, 21.09.2018)Verordnung des Schweizerischen Heilmittelinstituts über die vereinfachte Zulassung und das Meldeverfahren von Komplementär- und Phytoarzneimitteln (KPAV) vom 7. September 2018
- Ordinance of the Swiss Agency for Therapeutic Products on its fees (PDF, 157 kB, 21.09.2018)Verordnung des Schweizerischen Heilmittelinstituts über seine Gebühren
- Swissmedic Personnel Ordinance (PDF, 163 kB, 21.09.2018)Verordnung des Schweizerischen Heilmittelinstituts über sein Personal
Appendices
AMZV
VAZV
KPAV
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).
Permanent link of this page
www.swissmedic.ch/
legalfoundations-tpo4
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):
Supplementary information