13/14 March 2024
An agreement between the EU and Switzerland on the mutual recognition of conformity assessments (MRA = Mutual Recognition Agreement) has been existing for years. This MRA covers various areas, including medical devices and medicinal products. Adjustments were made in summer 2017.
One goal was to strengthen the exchange of information. Switzerland was to be given access to the EudraGMDP. This GMP database, managed by the European Medicines Agency (EMA), is intended to contain authorisations, GMP certificates and information on non-compliance with GMP principles from all contracting parties in a format conforming to the procedures published by the EU.
Swissmedic has now begun to enter information on GMP inspections and manufacturing authorisations for Swiss manufacturers into the database. This applies to all new or renewed authorisations and the associated GMP certificates.
Source: EMA Press Release