Revision of the Swiss Drug Law - an Overview

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

On 1 January 2019, the revised Swiss Therapeutic Products Act (HMG 2) and the majority of the revised implementing ordinances (Therapeutic Products Ordinance Package IV) entered into force - with some interesting GMP/GDP-relevant changes, e.g. in the following areas:

• Position of the Responsible Person (RP) in the company (the RP may not sit on the supervisory board of the company and must be able to take decisions independently of the management)
• Duty to report discontinuation of activities (RP!)
• Differentiation between market release and technical release: the so-called technical release is virtually the last step in manufacturing and requires a manufacturing licence; the market release is then part of the distribution of finished medicinal products and requires an import or wholesale licence (incl. market release).
• (Temporary) non-execution of an authorised activity (restriction or revocation possible if these activities are not exercised for more than 12 months)
• Extension of the authorisation requirement to brokers and agents (licence holders are obliged to ensure that their brokers/agents have an authorisation!)
• Placing of manufacturing orders by pure trading companies / trading abroad (tightening of due diligence obligations to avoid trading in counterfeits)

Some of the adapted definitions are also interesting.

On the SwissMedic website you can also find the presentations of the information events.