Contents
- 1. The marketing authorisation holder’s pharmacovigilance sys…
- 2. The marketing authorisation holder shall ensure that the p…
- 3. Marketing authorisation holders shall ensure that the qual…
- 4. Marketing authorisation holders shall have a sufficient nu…
- 5. All persons involved in the procedures and processes of th…
- 6. Marketing authorisation holders shall establish and docume…
- 7. Marketing authorisation holders shall retain full responsi…
6.Marketing authorisation holders shall establish and document back-up procedures to ensure business continuity with regard to the fulfilment of pharmacovigilance obligations.
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