This latest development is part of the mutual recognition agreement (MRA) between the EU and Switzerland, operational since June 2002 and most recently updated in August 2017. The latest amendment introduced the provisions on data entry to EudraGMDP by the Swiss authorities. Swissmedic has ‘read and write’ access to the data base and will be entering GMP compliance information on Swiss manufacturers, including those exporting to the EU. As a consequence, the regulatory requirement to provide original paper GMP certificates issued by EU or Swiss authorities will be replaced by either the provision of a reference to an entry in EudraGMDP or by means of a downloadable file or printout from the data base.
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