The new licensing system of Swissmedic has considerable impacts for current holders of establishment licenses – what you need to know regarding the latest regulatory changes.
Anyone who manufactures and/or trades medicinal products, including broker or agent activities from Switzerland or abroad, requires an establishment license from Swissmedic. The corresponding regulations are established in the Therapeutic Products Act (TPA) and the Medicinal Products Licensing Ordinance (MPLO).
As part of the latest revision of the TPA and the implementation of the Medicrime-Convention in Switzerland, the MLPO has also undergone a complete revision, which entered into force on 1 January 2019. The total revision of the MLPO resulted in various changes and standardizations of terms which includes that establishment licenses according to the TPA are no longer granted for a maximum term. This systematic change brings along a number of points that current license holder must take into consideration:
- Until now, the term of establishment licenses was limited to a maximum period of five years. In order to renew the license, an application for renewal had to be submitted on time. This will not apply in the future. Companies that are currently holders of an establishment license under the old regulation may continue to operate until the expiration of the term. However, a transfer into the new licensing system will not occur automatically. For this, the company must be proactive and submit an application with Swissmedic. The application must be submitted at least six months before the expiry of the existing license (Art. 73 para. 1 MLPO).
- Special caution is required whenever an approved activity (or parts thereof) is no longer carried out: The revised MLPO stipulates that Swissmedic may revoke a granted license in whole or in parts if a company has not exercised an authorized activity for more than 12 months (Art. 42 para. 2 ABMV). This provision intends to ensure that granted licenses do not remain valid for an indefinite period of time. If the company wishes to resume such activity later, it must reapply for a license which in general will trigger a prior inspection. Please note that the responsible person of the authorized company is obliged to inform Swissmedic if licensed activities are no longer carried out.
- Swissmedic may also suspend a granted establishment license if criminal proceedings regarding violations of the TPA or the Narcotics Act (NarcA) are pending or initiated against the responsible person (Art. 39 para. 3 MLPO). Compliance with the applicable provisions which is a prerequisite for upholding a granted establishment license will be checked during the regular inspections.