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Part 4 Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authorityF1

  1. 14Management of human resources
  2. 15Compliance management
  3. 16Record management and data retention
  4. 17Audit

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)