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…
5.Marketing authorisation holders shall ensure that the quality management system includes detailed policies, processes and procedures for risk management, monitoring of the benefit-risk balance, signal management and communication to all relevant stakeholders in accordance with Articles 16 to 20.
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