Swissmedic updates Responsible Person Requirements

Swissmedic has issued an updated version of the Technical Interpretation "Responsible Person: Requirements" (Document number: I-SMI.TI.17e, Version 7.0; valid from: 26.08.2024). This new version supersedes the previous edition, I-SMI.TI.17_06, dated 07.08.2023, and is effective immediately.

Key updates in this version include clarifications regarding the educational background and knowledge requirements for the Responsible Person (RP), particularly in relation to activities that demand Good Distribution Practice (GDP) and/or Good Manufacturing Practice (GMP) experience. Although compliance with the previous version typically remains sufficient, some situations may require immediate action from license holders.

Chapter 5.2 specifies that "GDP experience is required for the import and/or wholesale with or without market release activities, as well as export, brokerage- and/or agent activities and/or trade in foreign countries". This chapter also contains a precision, that "brokerage, agents and trade in foreign countries-activities do not count as GDP experience for the assumption of a function as a responsible person in a company with import, export and/or wholesale activities."

Furthermore, a Swissmedic press release highlights a requirement outlined in chapter 5.5. "Chapter 5.5 requires a good knowledge of the local language for the responsible person. Establishment licence holders whose already approved responsible person does not meet these requirements are given a period of 12 months from the date of publication of the updated technical interpretation to make the necessary adjustments, either by appointing a new responsible person with the required language skills or by ensuring that the responsible person acquires the required language skills within this period."

The PDF file is available for download on the Inspectorates website.