Chapter 2, Article 9, Paragraph 2. · Commission Implementing Regulation (EU) 2021/1281

Contents

1. Marketing authorisation holders shall have a process in pl…
2. Corrective and preventive action plans requested by the co…
3. Marketing authorisation holders shall monitor and assess t…
4. Change management shall provide for a controlled process o…

2.Corrective and preventive action plans requested by the competent authority shall document in writing an effective process, systematically addressing and minimising identified risk or defects. It shall include root cause analysis, address clear possible corrective and preventive measures, address timelines for action, and communication to relevant stakeholders.