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…
5.Marketing authorisation holders may be required by the competent authority or the Agency to communicate the corrective and preventive action plan in accordance with Article 9(2).
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