Contents
- 1. Marketing authorisation holders shall establish and implem…
- 2. The quality management system shall be described in the ph…
- 3. Marketing authorisation holders shall ensure that the qual…
- 4. Marketing authorisation holders shall ensure that the qual…
- 5. Marketing authorisation holders shall ensure that the qual…
- 6. Marketing authorisation holders shall ensure that the qual…
- 7. Marketing authorisation holders shall clearly define the r…
- 8. Marketing authorisation holders shall set up a quality man…
6.Marketing authorisation holders shall ensure that the quality management system includes detailed policies, processes and procedures for the maintenance and availability of the pharmacovigilance system master file in accordance with Articles 24 and 25.
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