David Pisarra

The Mutual Recognition Agreement

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The Mutual Recognition Agreement

On December 18, 2020, Posted by , With No Comments

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. By granting mutual recognition of products covered by free trade agreements with Canada and Korea, but which refuse to give the same treatment to products originating in the United Kingdom, the EU could violate WTO legislation. The current scope of the agreement covers only medicines for human use, with the exception of vaccines and plasma products. The products covered by the agreement include: The transition period for medicines for human use, which is covered by the agreement, ended on 11 July 2019: `Restrictions: capacity findings apply to routine inspections. In the future, the following types of products and inspections may be included in the scope of the agreement, pending further consideration: although accession negotiations have made little progress, Turkey is gradually adapting its legislation to EU legislation to remove technical obstacles. The results of THE CAB tests notified by Turkey are mutually recognised in the EU (and vice versa). 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. 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. 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. Mutual recognition agreements set out the conditions under which a party (non-member state) accepts the results of the compliance assessment (for example.B.

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