CHE/284
WTO/TBT
CH Schweiz
  • 01 - Allgemeines, Terminologie, Normung, Dokumentation
  • 07 - Mathematik, Naturwissenschaften
  • 11 - Medizintechnik
  • 30 - Pharmazeutische Erzeugnisse
2024-03-22
2023-12-19

PHARMACEUTICAL PRODUCTS (HS code(s): 30); Generalities. Terminology. Standardization. Documentation (ICS code(s): 01); Natural and applied sciences (ICS code(s): 07); Health care technology (ICS code(s): 11)

Revision of the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA); (25 page(s), in Italian), (25 page(s), in German), (25 page(s), in French)

The Therapeutic Products Act, which has been in force since 2002, is currently being revised . Topics which are affected:

·        Advanced therapy medicinal products (ATMPs)

·        Digitalisation in the prescription, dispensing and use of therapeutic products

·        Veterinary medicinal products

Swiss law is harmonised with EU law in order to reduce technical barriers to trade. The proposed changes are intended to bring greater clarity and certainty to the authorisation of advanced therapy medicinal products (ATMPs). In the area of veterinary medicinal products, a legal basis is created to prohibit the use of certain antimicrobial medicinal products (prevention of antibiotic resistance), to authorise innovative therapies and to permit authorisations to be valid for an unlimited period.