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. The agreement, initially announced in 2017, represents a three-year cooperation between the FDA and the EU and will allow all partners to recognise inspections carried out by each other. It is essential that “traditional” MRA does not require states to harmonize the rules (i.e. establishing technical standards and common rules) and do not require parties to one MRA to recognize each other`s requirements as equivalent – MRA is limited to the recognition of the partner`s CAB`s responsibility for assessing compliance. The text of the Protocol on Mutual Recognition of the Results of the Compliance Assessment is part of the Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union and its Member States. For example, the European Commission`s recent free trade agreements with Canada and Korea provide for the conclusion of a compliance assessment MMA, without asking their partners to align their regulatory requirements with those of the EU. 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. 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. What kind of mutual recognition agreements has the EU concluded? The current scope of the agreement covers only medicines for human use, with the exception of vaccines and plasma products. Among the products covered by the agreement are: these agreements benefit regulators by reducing double controls in any other area, allowing for a greater focus on sites likely to be at higher risk and to increase coverage of inspections of the overall supply chain.

The transition period for medicines for human use, which falls under the agreement, ended on 11 July 2019: the British document reaffirms the importance of regulatory autonomy – “respect for the regulatory law of each party” – but also recalls some previous considerations by proposing that the agreement “creates a framework for both parties so that the other party considers its technical regulation to be equivalent to its own regulation”. 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. One of the main benefits that the agreement will bring to European companies is the abandonment of batch testing for the importation of medicines from the United States. In the EU, the qualified person (PQ) is relieved of his responsibility for carrying out the checks in accordance with Article 22, paragraph 1, paragraph b), directives 75/319/EEC of the Council, provided these checks have been carried out in the United States. Each lot must also be accompanied by a lot certificate issued by the manufacturer and signed by the person responsible for the release of the lot. Although there has been little progress in accession negotiations, Turkey has gradually expanded its legislation on EU legislation to remove technical barriers.