Swissmedic Annual Report 2018

86
Corporate Governance
Organisation
Swissmedic is the Swiss regulatory and control authority for
therapeutic products. Its activities derive from Switzerland’s
therapeutic products legislation. The principal legal basis is
the Federal Act on Medicinal Products and Medical Devices
(Therapeutic Products Act, TPA). Swissmedic is attached to
the Federal Department of Home Affairs. The Swiss Agency
for Therapeutic Products is a Bern-based federal public institute
that is independently organised and managed, and
has its own budget.
The public services it provides are described in a service
mandate issued by the Federal Council and in the service
level agreement concluded each year with the Federal Office
of Home Affairs. Swissmedic’s strategic plan consists of
the guiding principles and the strategic objectives. The strategic
plan is adopted by the Agency Council and is based
on the legal provisions (Therapeutic Products Act/Ordinances)
and the mandate from the owner (service mandate
and service level agreement).
Tasks
• Authorisation of medicinal products
• Issuing licences for manufacturing and wholesale
trading, and conducting inspections
• Market surveillance of medicinal products and medical
devices
• Criminal prosecution
• Licensing and monitoring of clinical trials
• Laboratory testing of medicinal product quality
• Drawing up standards
• Providing information
• National and international cooperation