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Schedule 12A Further provision as to the performance of pharmacovigilance activitiesF1

  1. 1Pharmacovigilance system master file
  2. 2Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority and holders
  3. 3Minimum requirements for the quality systems for the performance of pharmacovigilance activities by holders
  4. 4Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority
  5. 5Use of terminology, formats and standards
  6. 6Transmission of reports of suspected adverse reactions
  7. 7Risk management plans
  8. 8Periodic safety update reports
  9. 9Post-authorisation safety studies

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)