Mutual recognition agreements shall specify the conditions under which one Party (third country) accepts the results of conformity assessment (e.B. tests or certifications) carried out by the notified conformity assessment bodies (CABs) of the other Party (EU) to demonstrate compliance with the requirements of the first Party (third country) and vice versa. Mutual Recognition Agreements (MRAs) promote trade in goods between the EU and third countries and facilitate market access. These are bilateral agreements designed to benefit industry by facilitating access to conformity assessment. MRAs are most often applied to goods, such as. B various quality control MRAs. However, the term also applies to agreements on the recognition of professional qualifications and decisions in criminal matters. [2] If your company needs help interpreting the impact of international cooperation agreements on your multinational activities, we can help! Please contact David Lonza at D.Lonza@LachmanConsultants.com. Mutual Recognition Agreements (MRAs) for conformity assessment are agreements between governments to facilitate trade in telecommunications equipment. MRAs shall establish procedures for Parties to recognise other relevant conformity assessment bodies (CABs, such as testing laboratories or certification bodies) and to accept the results of conformity assessment from such CERTIFICATION bodies for regulatory purposes.

*Limitations: Capacity requirements apply to routine surveillance inspections. In the future, the following types of products and inspections could be included in the scope of the Agreement, subject to additional testing: Countries participating in the Agreement may designate conformity assessment bodies (ACIs), laboratories and inspection bodies for the scope of the Agreement. The MRA with Israel is an agreement on conformity assessment and recognition of industrial products (ACAA). This is a specific type of MRA based on the alignment of the legal system and infrastructure of the country concerned with that of the EU. The transition period for medicinal products for human use covered by the agreement ended on 11 July 2019: the European Union (EU) signed Mutual Recognition Agreements (MRAs) with third country authorities on the conformity assessment of regulated products. These agreements contain a sectoral annex on the mutual recognition of good manufacturing practice (GMP) inspections and the certification of batches of medicinal products for human and veterinary use. MRAs are trade agreements that aim to facilitate market access and promote greater international harmonization of compliance standards while protecting consumer safety. The issue of mutual recognition in criminal matters was discussed at the Cardiff European Council of 15 and 16 June 1998 and was further discussed at the Tampere European Council in October 1999. On 15 January 2021, a programme of EU measures to implement the principle of mutual recognition of decisions in criminal matters was published. [2] The Mutual Recognition Agreement (MRA) between the FDA and the European Union allows drug inspectors to rely on information from drug inspections conducted within each other`s borders. Under the Food and Drug Administration Safety and Innovation Act enacted in 2012, the FDA has the authority to enter into agreements to recognize drug inspections by foreign regulatory agencies if the FDA has determined that those agencies are capable of conducting inspections that meet U.S. requirements.

The FDA and the EU have been working together since May 2014 to assess how they each inspect drug manufacturers and to assess the risks and benefits of mutual recognition of drug inspections. The text of the Protocol on the Mutual Recognition of Conformity Assessment Results is part of the Comprehensive Economic and Trade Agreement (CETA) between Canada, of the one part, and the European Union and its Member States, of the other part. During a transitional period, the authorities shall mutually assess each other`s pharmaceutical legislation, guidelines and regulatory systems. www.nist.gov/mutual-recognition-agreements-mras The EU-Australia agreement covers the following sectors These agreements benefit regulators by reducing double inspections in each other`s territory, allowing for a greater focus on sites that might be more at risk and expanding the coverage of inspections in the global supply chain. NIST is the U.S. designating authority for MRAs. NIST is responsible for designating qualified U.S. CABs for our various MRA partners. NIST receives, reviews and processes applications from CACs recognized by our MRA partners.

MrA`s partner regulators officially recognize CABs for their specific technical regulations/standards and/or certification requirements. Recognized U.S. CABs can then help U.S. manufacturers meet their testing and/or certification requirements for specific economies. Mutual recognition occurs when two or more countries or other institutions recognise each other`s decisions or policies, for example in the field of conformity assessment, professional qualifications or criminal matters. A Mutual Recognition Agreement (MRA) is an international agreement in which two or more countries agree to carry out mutual assessments, decisions or conformity results (e.B. Certifications or test results). A mutual recognition agreement is an international agreement based on such an agreement. .

This content applies to medicinal products for human and veterinary use. . The European Commission is responsible for negotiating MRAs with partner countries on behalf of the EU. The European Commission can consult the EMA on regulatory and scientific issues as part of this process. European companies wishing to export to Australia, Canada, Japan, New Zealand, the United States, Israel or Switzerland should be aware of the notified Mutual Recognition Agreements (MRAs) and Conformity Assessment Bodies (CABs). In 2017, the MRA was suspended and included in the EU-Canada Comprehensive Economic and Trade Agreement (CETA), which will apply provisionally from September 2017. The suspended MRA will end as soon as CETA enters fully into force, pending RATIFICATION by EU Member States. MRAs have become increasingly common since the founding of the World Trade Organization in 1995. They were forged within and between different trading blocs, including APEC and the European Union.

[1] Products manufactured in the territories of the EU and Canada. The EMA participates in operational activities once the MRAs are in force, including: Chapters 12 (motor vehicles) and 13 (agricultural or forestry tractors) (medicines, good manufacturing practice (GMP) inspection and batch certification) For the purposes of this sectoral chapter, “conformity assessment bodies” means the official GMP inspection services of each Party. For the purposes of these sectoral Chapters, `conformity assessment bodies` means the authorities, technical services and testing bodies responsible for type-approval. Transitional provisions apply to veterinary medicinal products, vaccines intended for human consumption and medicinal products derived from plasma. MRAs include relevant lists of laboratories, control bodies and conformity assessment bodies designated both in the EU and in the third country. Links to existing lists can be found on this website. Israel and the EU recognize the official releases of consignments by the authorities of the other party. .