Contents
- 1. Marketing authorisation holders shall be prepared for insp…
- 2. Marketing authorisation holders may be inspected on the si…
- 3. Marketing authorisation holders shall provide the necessar…
- 4. Pharmacovigilance inspections may be either routine inspec…
- 5. Marketing authorisation holders may be required by the com…
1.Marketing authorisation holders shall be prepared for inspections of their pharmacovigilance system and the corresponding pharmacovigilance system master file in accordance with Article 123(6) and Article 126 of Regulation (EU) 2019/6 and shall ensure the same for any person mentioned in Article 26(1).
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