OpenLegislation

Chapter I Pharmacovigilance system master fileF1

United Kingdom

Original text. Later amendments are not shown.

  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
  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

Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(t) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)