Operating licenses and 42 MPLO

Appropriate processes must be defined in the company's internal quality assurance system for the activities authorised by Swissmedic. No applications for "just in case" activities are permitted. According to Art. 42 para. 2 of the Ordinance on Licensing in the Medicinal Products Sector (MPLO), Swissmedic is entitled to withdraw a company's license for activities that have not been carried out for more than 12 months (sunset clause for operating licenses).