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Countries In The Mutual Recognition Agreement

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Countries In The Mutual Recognition Agreement

The EU-Australia agreement covers the following sectors 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. 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. 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. Among the benefits of the EU-US mutual recognition agreement, European Commission trade negotiators recently objected to mutual recognition of compliance assessment by UK testing laboratories. products manufactured on the territory of the EU and Israel, as well as manufacturers from third countries that are controlled by the regulator of one of the parties if the product is re-tested in one of the parties. The MRA agreement recognises inspections of production sites for medicinal products for human use in different areas. This means that the FDA now has a total of 26 Member States whose inspection results can replace their own inspections. These agreements benefit regulators by reducing dual controls in any other area, allowing for a greater focus on sites likely to be at higher risk and increased coverage of global supply chain inspections. The UK document reaffirms the importance of regulatory autonomy – “respect for the regulatory law of each party” – but also follows earlier considerations by proposing that the agreement “creates a framework for both parties to require the other to consider its technical regulation as equivalent to its own regulation.”


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