OpenLegislation

Part 1 Pharmacovigilance system master fileF1

  1. 1Structure of the pharmacovigilance system master file
  2. 2Content of the pharmacovigilance system master file
  3. 3Content of the Annex to the pharmacovigilance system master file
  4. 4Maintenance of the pharmacovigilance system master file
  5. 5Form of the documents contained in the pharmacovigilance system master file
  6. 6Subcontracting
  7. 7Availability and location of the pharmacovigilance system master file

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)