Swissmedic: Update of Responsible Person Requirements

Swissmedic published an updated version of Technical Interpretation 17: Responsible Person: requirements on 26 August 2024. The document outlines the Swiss Inspectorate’s understanding of an RP in accordance with the Medicinal Products Licensing Ordinance (MPLO). It can also serve as a reference for companies to assess whether an individual meets the criteria for applying to Swissmedic to act as an RP.

What’s new in Version 7.0?

• Chapters 5.1 and 5.2 provide precise information about educational aspects and activities where experience in GDP/GMP practices is required.
• The experience with regulatory issues as acceptable criterium has been removed and a precision about the experience required for an area with specific risks was added (e.g. sterile medicinal products)
• It is specified that brokerage, agents, and trade in foreign countries do not count as GDP experience.
• Language requirements are clarified in Chapter 5.5
• Chapter 5.6. specifies the understanding of what is the direct supervision of a facility.
• New Chapter 5.6.1 on remote technical and market release
• Chapter 5.2 includes:
• - Precisions about the expected presence on site of the RPs,
  - Precision of conditions permitting a reduction of physical presence on site,
  - Precision on the cases where an intensified presence on site is expected.
• New Chapter on 5.6.3 about the workload of RPs
• Chapter 6 clarifies that the same requirements apply to the deputy RP, inclusive domicile.
• Chapter 7 specifies possibilities and conditions for task delegation as well as critical processes and release activities.
• Chapter 8 includes the event of absence of the RP beyond the normal holiday leave.

In most cases, compliance with the previous technical interpretation guarantees compliance with the current version. The license holder is generally required to adapt immediately. Also, for the inspectorates the updated technical interpretation applies with immediate effect.

License holders with approved responsible persons who do not meet the requirements have 12 months to make the necessary adjustments. This could be either by appointing a new RP with the required language skills or by ensuring that an RP acquires the required language skills within this period. Swissmedic expects responsible persons to speak one of the official local languages of the canton where the inspection takes place and where the site is located.

Source:

Swissmedic: Technical interpretation 17 “Responsible Person: requirements”