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Apr 12, 2021

Swiss Mutual Recognition Agreement



1. A committee for mutual recognition is established in the assessment of compliance (the so-called “committee”). It is made up of representatives of the parties and is responsible for managing and monitoring the smooth running of this agreement. To this end, it makes recommendations and makes decisions in the circumstances of this agreement. It is a mutual agreement. Despite the effectiveness of the EU-Swiss MRA in facilitating market access between Switzerland and the EU, Swiss manufacturers of DMD/DIV have reached a veil of uncertainty, as there are signs that the EU could make the renewal of the EU-Switzerland conditional on Switzerland`s adoption of a Swiss EU IFA under negotiation. The aim of the IFA is to streamline the harmonisation of Swiss law with EU law, to monitor the implementation of bilateral market access agreements and to resolve interpretive issues through dispute resolution. Considering that the close relations between the Community and Switzerland, on the one hand, and Iceland, Liechtenstein and Norway, on the other, make it appropriate to conclude parallel agreements between these countries and Switzerland, considering that mutual recognition agreements contribute to the harmonisation of technical rules, standards and principles governing the implementation of compliance assessment procedures at international level; With respect to drugs, the results of clinical trials conducted on the territory of the parties to this agreement are currently accepted for inclusion in marketing authorization applications and their modifications or extensions. In principle, the parties agree to continue these clinical trials for the purpose of authorizing marketing authorization. They agree to work towards a reconciliation of good clinical practices through the implementation of the current Helsinki and Tokyo declarations and all relevant clinical trial guidelines adopted at the International Conference on Harmonization. However, in view of the evolution of legislation on inspections and authorisations for clinical trials in the European Community, it is necessary, in the near future, to examine detailed rules on mutual recognition of the official controls of these trials and to define them in a specific chapter.

The parties undertake to update the annexes to the Mutual Recognition Agreement for Compliance Assessment no later than one month after it comes into force. Although WTO members have some discretion in recognizing other members` rules and procedures, this discretion does not apply to allowing an importing WTO member to link the recognition of the regulations and procedures of a WTO executive member to the conclusion of another unrelated contract, such as the IFA, between the two members. Any manufacturer who puts on the market the medical devices covered by Article 14 of Directive 93/42/EEC informs the competent authorities of the contracting party in which it has its registered head office information covered by this article. The contracting parties recognize each other. The manufacturer is not required to appoint a person responsible for marketing entities established in the territory of the other party. Article 10 of the MRA agreement provides for the creation of a joint committee consisting of one representative for each party charged with monitoring the smooth running of the agreement.