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Revision 1.7.2021 - Updating of KPTPO annexes

01.07.2021

Updating of KPTPO annexes

In winter 2020/2021, Annexes 5, 6 and 8–10 (published by Swissmedic) of the Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Licensing of Complementary and Phytotherapeutic Products (Complementary and Phytotherapeutic Products Ordinance, KPTPO; SR 812.212.24) were reviewed in light of the current status of science and technology and adapted accordingly on the basis of the various reports received.

At a meeting of Swissmedic’s Agency Council on 7 May 2021 following the conclusion of the consultative process involving subject-matter experts and official bodies, it was decided that Annexes 5, 6 and 8–10 of the KPTPO should be amended with effect from 1 July 2021.

The following KPTPO annexes have been revised:

  • Annex 5:        List of lozenges
  • Annex 6:        HAS list
  • Annex 8:        Gemmotherapy list
  • Annex 9:        List of standard works
  • Annex 10:      TAS list

Zugehörige Dokumente

Liste «Bonbons» (with amendments) (PDF, 219 kB, 01.07.2021)KPAV, Anhang 5 (Art. 13)

Liste HAS (with amendments) (PDF, 1 MB, 01.07.2021)KPAV, Anhang 6 (Art 15 Abs.1, 20 Bst. a, 27 Bst. a und 39 Abs. 1 Bst.d)

Liste Gemmotherapie (with amendments) (PDF, 90 kB, 01.07.2021)KPAV, Anhang 8 (Art. 27 Bst. b und 35 Abs. 2)

Liste der Standardwerke (with amendments) (PDF, 113 kB, 01.07.2021)KPAV, Anhang 9 (Art. 30 Abs. 2 und 31 Abs. 2)

Liste TAS (with amendments) (PDF, 403 kB, 01.07.2021)KPAV, Anhang 10 (Art. 31 Abs, 1, 32 und 45 Abs. 2)

Erläuternder Bericht zur Nachführung der Anhänge mit Veröffentlichung durch Verweis in der AS und SR (PDF, 137 kB, 01.07.2021)Anhänge 5, 6, 8 bis 10 der Komplementär- und Phytoarzneimittelverordnung (KPAV; SR 812.212.24)

ZL103_00_004e WL Guidance document Criteria Annexes 4–10 KPTPO (PDF, 259 kB, 01.05.2023)

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