Switzerland: Changes for the Qualification of QPs (Responsible Person; RP in Switzerland)

As part of the agreement of 21 June 1999 between the Swiss Confederation and the European Community on the mutual recognition of conformity assessments (Mutual Recognition Agreement, MRA), Switzerland has undertaken to comply with European legislation insofar as it contains GMP rules. The requirement for a 'Qualified Person' was realised by implementing the Responsible Person (RP) resp. Fachtechnisch verantwortliche Person (FvP) in the German speaking part. There are interpretations of this in a so-called 'technical interpretation' documents. These interpretations are used when legal regulations concern technical issues that require a more detailed explanation. Technical Interpretation 17 'Responsible Person: requirements' has now been updated with some retroactively applicable requirements. If one of the numerous clarifications means that requirements of the previous version are no longer fulfilled, an immediate adjustment is required.

Example: Chapter 5.5 requires a good knowledge of the local language for the Responsible Person. If an already approved RP does not fulfil these requirements, then the company has 12 months from the publication date of the updated technical interpretation to make the necessary adjustments by either appointing a new RP with the required language skills or ensuring that the current RP acquires the required language skills within this period.

The changes are summarised in Chapter 9 of the document.