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Part 3 Minimum requirements for the quality systems for the performance of pharmacovigilance activities by holdersF1

  1. 10Management of human resources
  2. 11Compliance management
  3. 12Record management and data retention
  4. 13Audit

Annotations

Textual amendments

F1

Sch. 12A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 6 (as amended by S.I. 2019/1385, reg. 1, Sch. 1 para. 9 and S.I. 2020/1488, reg. 1, Sch. 2 para. 192); 2020 c. 1, Sch. 5 para. 1(1)