Agreement On Mutual Recognition

Mutual recognition agreements (MRAs) promote trade in goods between the European Union and third countries and facilitate market access. These are bilateral agreements designed to facilitate industry access to compliance assessment. The EU internal market is the most comprehensive version of mutual recognition between trading partners. According to the Dijon Cassis principle, a product that can be legally sold in one Member State can be legally sold in any other Member State, even if the rules are not harmonised. However, European Commission trade negotiators recently rejected mutual recognition of the compliance assessment by UK testing laboratories. The European Union (EU) has signed Mutual Recognition Agreements (MRA) with third-country authorities on the assessment of compliance of regulated products. These agreements contain a sectoral annex on mutual recognition of good manufacturing practice inspections (GMPs) and certification of batches of medicines for human and veterinary use. If the EU refuses to negotiate a similar system of mutual recognition with the UK, this may violate the most favoured nation obligation (MPF) under WTO law. The MFN is a non-discrimination rule that requires that any benefit granted to products originating in one country be granted to similar products originating in other countries.

During a transitional period, the authorities assess each other`s pharmaceutical legislation, guidelines and regulatory systems under the agreement. Parties to an MRA do not need to change their technical rules and that is why the UK government is now proposing MRA for compliance assessment as part of its new trade agreements. In the Brexit negotiations, the UK government called for mutual recognition of the rules, including in Theresa May`s florence speech and as an option for future regulation of financial services, but refused by the EU. The transition period for medicines for human use, which falls under the agreement, ended on 11 July 2019: the Mutual Recognition Agreement (MRA) between the FDA and the European Union allows drug inspectors to rely on information from drug inspections carried out within the boundaries of the other section. Under the Drug Safety and Safety Act passed in 2012, the FDA has the authority to enter into agreements on the recognition of drug inspections by foreign regulators when the FDA has found that these authorities are able to conduct inspections in accordance with U.S. requirements. The FDA and the EU have been cooperating since May 2014 to assess how they control drug manufacturers and assess the risk and benefits of mutual recognition of inspections. There are other examples of mutual recognition of the rules, including the EU-US marine equipment regulation in 2004, the Trans-Tasman Mutual Recognition Arrangement between Australia and New Zealand (TTMRA) in 1998 and the EU-Swiss MRA in 2002. The Johnson government has moved away from these approaches. In its proposal for a comprehensive free trade agreement with the EU, the UK proposes an agreement on mutual recognition of compliance assessment that is „consistent“ with the provisions of the EU agreement with Canada. A separate agreement on the certification of marine equipment is also proposed as part of the agreement between the EU and the United States. However, recent free trade agreements indicate a change in approach and acceptance of „traditional“ MMAs.

For example, Article 4.6 and Article 7.21, paragraph 4, of the EU-Korea Free Trade Agreement provide for the negotiation of mutual recognition of the assessment of the compliance of goods and services. Mutual recognition agreement for compliance assessment, certificates and markings between Canada and Iceland, Liechtenstein and Norway (which came into force on January 1, 2001). Covered sectors: telecommunications terminal equipment, electromagnetic compatibility (CEM), electrical safety, pleasure boats, pharmaceuticals (good manufacturing processes, GMP) and med devices