Good engineering practice of updating standards

12-Jan-2021 22:25

Marketing authorisation applicants are responsible to ensure that the proposed manufacturing sites included in the marketing auhtorisation application comply with GMP.For more information, see section 5.2 Inspections of the Pre-authorisation guidance.Manufacturing sites outside the EU are inspected by the national competent authority of the Member State where the EU importer is located, unless a mutual recognition agreement (MRA) is in place between the EU and the country concerned.If an MRA applies, the authorities mutually rely on each other's inspections.

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They must comply with EU GMP to obtain a manufacturing or import authorisation.The group provides a forum for harmonisation and discussion of common issues, such as: EMA maintains a compilation of GMP and good distribution practice (GDP) inspection-related procedures and forms agreed by all Member States.