The quality, safety and efficacy of medicinal products and medical devices continue to be monitored by Swissmedic even after they have obtained marketing authorisation.
Market surveillance for medicinal products
Swissmedic records safety signals associated with medicinal products, vaccines, labile blood products and veterinary medicines based on reports of adverse drug reactions (ADR) from within Switzerland. If the investigations confirm a new risk, Swissmedic initiates the necessary measures.
Swissmedic's tasks also include the assessment of international data on the safety of medicines.
Swissmedic records quality defects in medicinal products and takes the necessary measures. Depending on the potential risk of the defect in question, a batch recall or a circular for healthcare professionals is necessary.
Swissmedic receives reports on illegal products, activities and illegal imports of medicines - particularly illegal distribution - examines them and, if necessary, initiates measures.
A further important aspect of market monitoring is the international exchange of information and the examination of foreign reports with regard to their significance for the Swiss market.
Imports of medicines are checked in collaboration with the customs authorities. Swissmedic also controls and monitors the advertising of medicinal products.
Market surveillance for medical devices
Swissmedic is also responsible for monitoring medical devices that are already on the market. Furthermore, Swissmedic monitors clinical trials of medical devices that are not yet authorised for the market.
Medical devices encompass a very large range of products, including implants such as hip prostheses and heart pacemakers, in vitro diagnostics such as HIV tests, or products for the general public such as contact lenses.