Swissmedic
REGULATORY UPDATE
Changes to the Guidance document Authorisation human medicinal product under Art. 13 TPA
Published: 3/1/2026Detected: 3/26/2026
Summary preview
Updates the Swiss guidance on authorisation of human medicinal products under Art. 13 of the Swiss Therapeutic Products Act (TPA), signaling changes that may affect how sponsors prepare and structure submissions.
Get the full analysis, free
Create a free account to see the complete summary, key takeaways, and why this matters for your products, and to get alerts like this by email.
Create free accountmanufacturing
quality
clinical
safety
labeling
#Swissmedic
#Art. 13 TPA
#human medicinal product
#marketing authorisation
#guidance
Official Source Document Source Verified
Access the original document directly from SWISSMEDIC.
More from Swissmedic
- Changes to the Guidance document “Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import)”10/1/2026
- Adaptations required for issuing establishment licences and GMP certificates for manufacturers of active substances10/1/2026
- Revision of the Guidance document Authorisation Biosimilar10/1/2026
- Swissmedic Portal Release – New Features Available from 23 September 20269/24/2026
- I-SMI.TI.22e Notifications according to Article 41, MPLO9/23/2026