If your company needs help interpreting the impact that international cooperation agreements will have on your multinational activities, we can help! Please contact David Lonza at D.Lonza@LachmanConsultants.com. Mutual recognition agreements/agreements (MRAs) for compliance assessment are agreements between governments to facilitate trade in telecommunications equipment. MRA establish procedures for contracting parties to recognize the appropriate compliance assessment bodies (CABs – such as test laboratories or certification bodies) and to accept the results of the compliance assessment of these CABs for regulatory purposes. The specific benefits are present in each Mutual Recognition Agreement (MRA), but in general the benefits are: 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, of one party and the European Union and its Member States, on the other hand, www.nist.gov/mutual-recognition-agreements-mras mutual recognition agreements define the conditions under which one party (non-member state) accepts the results of compliance assessment (e.g.B. tests or certifications) carried out by the compliance assessment body designated by the other party (the EU) in order to demonstrate compliance with the requirements of the first party (non-member country) and vice versa. NIST acts as the U.S. Designating Authority for MRAs. NIST is responsible for the designation of qualified U.S. CABs to our various MRA partners.
NIST receives, reviews and processes CAB applications that are recognized by our MRA partners. The regulatory authorities of MRA partners formally recognise CABs for their specific technical rules/standards and/or certification requirements. Recognized U.S. CABs will then be able to assist U.S. manufacturers in their testing and/or certification requirements for certain savings. 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 Mutual Recognition Agreement (MRA) between the FDA and the European Union allows drug inspectors to rely on information from anti-drug inspections carried out within the other country`s borders. 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. (Drugs, Good Manufacturing Practice Trials (GMP) and Batch Certification) For the purposes of this sectoral chapter, “compliance assessment agencies” are the official inspection services of the BMOs of each party. For the purposes of this sectoral chapter, “compliance assessment agencies” are also responsible for calibration (80 KB) (audit services and laboratories). . NIST also provides technical assistance to the U.S. Trade Representative`s Office (USTR) and the Federal Communications Commission (FCC) for the negotiation and implementation of MRA. The USTR leads the negotiations and signs the agreements. The FCC, as the U.S. Telecom Regulatory Authority, regulates telecommunications equipment on the U.S. market and officially recognizes Elands and MRA-Partner national CABs that meet FCC requirements. For the purposes of this sectoral chapter, “compliance assessment bodies” are defined as the relevant authorities in Switzerland for the marketing of biocides: Federal Office of Public Health, Chemical Reporting Cell The following links provide an overview of the EMA`s global efforts in the field of MRA and the efforts made to date by the FDA, the regulated authority.