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What Is Mutual Recognition Agreement

Mutual Recognition Agreements/Arrangements (MRAs) for conformity assessment are agreements between governments to facilitate trade in telecommunications equipment. MRBs shall establish procedures that allow Parties to mutually recognize competent conformity assessment bodies (CACs – such as testing laboratories or certification bodies) and to accept the results of the conformity assessment of such BCAs for regulatory purposes. During a transition period, the authorities will mutually assess pharmaceutical legislation, guidance and regulatory systems under the agreement. The EU`s single market is the most comprehensive version of mutual recognition between trading partners. According to the Cassis de Dijon principle, a product that can be legally sold in one Member State, even if the rules are not harmonised, can be legally sold in any other Member State. The European Union (EU) has signed Mutual Recognition Agreements (MRAs) with third country authorities on conformity assessment of regulated products. These agreements contain a sectoral annex on the mutual recognition of GMP (Good Manufacturing Practice) inspections and the certification of batches of medicinal products for human and veterinary use. Recently, however, European Commission trade negotiators rejected the mutual recognition of testing laboratories assessed for compliance by UK testing laboratories. THE ECAS are usually concluded with candidate countries with which the EU has concluded association agreements (see our explanation of the association agreements) and represent a step in the accession process. The objective of the PECA is to align the technical regulations of a candidate country with those of the EU with a view to its accession to the EU. This type of MRA is inherently temporary because it disappears when the country joins the EU`s single market.

What types of mutual recognition agreements has the EU concluded? By granting mutual recognition to products covered by free trade agreements with Canada and Korea, but refusing to treat products originating in the UK on an equal footing, the EU could be violating WTO law. 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 it determines that those agencies are able to conduct inspections that comply with 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. .

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