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GCP and Guideline Updates
Date: 26/08/2009
Type: Guideline
Region: Europe
Subject: New EMEA guideline on Co-ordination of Inspections

EMEA has produced another new guideline on inspections covering co-ordination between member states of inspections to verify GCP compliance of Marketing Authorisation Applications under the Mutual Recognition or Decentralised procedures.  It doesn't cover inspections for the Centralised Procedure or routine national inspection procedures.  There has also been a revision to the guideline on exchange of inspection reports.

You can read the new guideline here: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2009_05_07-guidance-coordination.pdf

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