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Validation issues frequently seen with initial MAAs

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Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. 7 August 2020 EMA/454165/2015 Ver. Human Medicines Validation issues frequently seen with initial MAAs This document provides a list of issues frequently seen during the administrative Validation of initial MAAs.

Validation issues frequently seen with initial MAAs. ... GCP Compliance (see also Q.3.4.1 of the Pre-Authorisation guidance) ... • list of GCP inspections conducted/planned by any regulatory authority (indicating the site inspected/to be inspected, the date of inspection and the regulatory authority involved). ...

  Validation, Regulatory, Compliance, Issue, Validation issues

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