Key dates & events

Date Information/Topics  


Go-live/publication of new specification documents



Swissmedic information event on the revision of the Therapeutic Products Act (TPA)

Thursday 25 October 2018


  • Harmonisation of "variations" with EU variations
  • Reallocation of products to dispensing categories
  • Transitional rules
  • New provisions with regard to Art. 13 TPA
  • Implementation of Art. 14 para. 1 let. abis-quater


  • Parallel session 1 Paediatric investigation plan, temporary authorisations, document protection and orphan drugs
  • Parallel session 2 Rules for veterinary medicinal products
  • Parallel session 3 Rules for complementary and herbal medicines
Congress Centre Kursaal Bern
01.11.2018 Go-live/publication of amended eCTD M1 specifications  


Swissmedic information event on the revision of the Therapeutic Products Act (TPA)

Friday 9 November 2018


  • Swiss Public Assessment Report (SwissPAR) and Public Summary SwissPAR: publication, receipt of application and authorisation decisions
  • Full declaration, new templates for patient information and information for healthcare professionals, black triangle, Italian information for healthcare professionals, publication of product information
  • Redesign of forms, Internet lists


  • Revision of the Medicinal Products Licensing Ordinance (MPLO): introduction in law
  • Revision of MPLO, part 1: definitions, licence types, requirements for RP
  • New establishment licences, new GMP/GDP certificates
  • Revision of MPLO, part 2: individual import licences, special licences, compassionate use
Congress Centre Kursaal Bern
2019 Most of the provisions of the TPA and the relevant implementing provisions are to enter into force as originally planned on 1 January 2019. The Federal Council shall determine the date when the provisions come into force.  

Last modification 29.06.2018

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