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EU – US mutual recognition of GMP inspections: agreement published

20 March 2017

Focus on Regulation

On 4 March 2017, the agreement between the EU and the US governing the reciprocal recognition of GMP inspections of manufacturing sites for medicinal products for human use was published in the Official Journal of the EU: “Decision No 1/2017 of 1 March 2017 of the Joint Committee established under Article 14 of the Agreement on Mutual Recognition between the European Community and the United States of America, amending the Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)” (the “Agreement“).

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