Switzerland: important Amendments to the MRA

For years now, there has been an agreement between the EU and Switzerland on mutual recognition of conformity assessments (Mutual Recognition Agreement, MRA). This MRA includes various fields, including medical devices and medicinal products. In summer of 2017, changes had been made to it which have now been published in the official journal of the European Union [2017/2018].

Annex G of Chapter 15, which is relevant for medicinal products, has been supplemented by further details on the promotion of collaboration between the individual supervisory agencies and inspectorates. Referrals to laws and regulations have also been updated.

Recognition of inspections in third countries

The contracting parties may now also recognise inspections of manufacturers in third countries. This also includes inspections by the EDQM (European Directorate for the Quality of Medicines).

For inspections conducted in third countries, the competent authority may certify upon application by an exporter, importer or the competent authority that the inspected manufacturer complies with the recognised GMP requirements - or not.

The request for information exchange is now more elaborate. Switzerland now can and is supposed to use EudraGMDP. In this database, which is administrated by the European Medicines Agency EMA, all contractual parties should submit authorisations, GMP certificates and information on non-compliance with GMP. The data is to be supplied in a format compliant with the procedures published by the EU.

Better coordination

The contractual parties are to cooperate more effectively by adequate burden sharing in order to make the most of their inspection resources. This passage is also new.

Import by an MRA partner

For products which are imported from a third country and then exported to a region of the contractual partner, the facilitations of the MRA only apply, if:

• each batch of the medicinal products has been subject to the re-control in the territory of one of the Parties and
• if the manufacturer in the third country has been subject to the inspection by the competent authority of either Party.

If those requirements are not met, each contractual partner may demand a re-control in its territory.