23-25 October 2019
In the Swissmedic Journal 05/2017 - Swissmedic's official publication paper- the Swiss Agency for Therapeutic Products released specifications about the Swiss Responsible Person's independence and obligation of presence (the Responsible Person - RP - or "Fachtechnisch verantwortliche" Person (FVP) is equivalent to the Qualified Person in the EU). The revised requirements have also been published in the Technical Interpretation I-SMI.TI.17 which is also available on the Swissmedic website.
According to the Swiss legislation, the Responsible Person (RP) has to have the necessary authorisation to execute his/her responsibility - in particular with regard to the market release (Medicinal Products Licensing Ordinance, art. 5, paragraph 1). This implies a certain independence, also from the upper management (paragraph 2). Details regarding the scope of this independence have now been provided:
According to the Swissmedic, independence is no longer guaranteed in case of a personal union of RP as CEO, principal shareholder, or chairman of the board. As a result, this constellation is no longer acceptable for Swissmedic.
The necessary technical supervision of the RP relies on his/her regular presence at the facilities. Nevertheless, according to art. 5 paragraph 6 of the Medicinal Products Licensing Ordinance it is basically possible to carry out the function on a part-time basis. Now, the conditions for that have also been specified:
The direct supervision by a part-time RP is understood as the supervision of at least all the critical steps/operations with regard to the company's facilities as well as the guarantee of compliance with the legal provisions. This implies that the minimum hours of presence have to be defined in a contract. The considerations forming the basis for the specified minimum hours of presence should be stated in writing and the minimum hours of presence "should normally not be below 10% of a full time position".
The new requirements will enter into force as of 1st July 2017 without any transition period.