EU MRAs Finalized With USA And Canada

16 June 1997

The European Union and the USA have finalized a Mutual RecognitionAgreement covering trade worth over $40 billion a year, which was due to be formally initialled last week.

The agreement covers medicinal products, medical devices, telecommunications terminal equipment, electromagnetic compatibility, electrical safety and recreational craft. Other sectors including veterinary vaccines are due to be added in future.

Under the medicinal products MRA, the EU and the USA will accept each other's inspections and recognize Good Manufacturing Practice clearance given to production sites passing those inspections, eliminating most overseas reinspections by the importing country. After a three-year transition period to determine the equivalence of EU and US inspection systems, the two will exchange their inspection reports which will generally be endorsed without reinspection or additional queries.

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