OpenLegislation

Part 8 Pharmacovigilance

United Kingdom

  1. 55Qualified persons responsible for pharmacovigilance
  2. 56Duties of marketing authorisation holder in relation to pharmacovigilance
  3. 56ADuties of marketing authorisation holder in relation to signal management process
  4. 56BDuties of qualified person (pharmacovigilance)
  5. 56CSignal management process
  6. 57Adverse events following administration of a veterinary medicinal product
  7. 58Adverse reactions to a veterinary medicinal product administered in another country
  8. 59Annual benefit-risk reports
  9. 60Release of information by the marketing authorisation holder
  10. 60APharmacovigilance inspections by Secretary of State
  11. 60BPowers of Secretary of State in relation to signal management process
  12. 61Action taken on account of pharmacovigilance

Notes on Schedule 1

Textual amendments

F1

Words in Sch. 1 heading inserted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 4(7)(a)

F2

Words in Sch. 1 heading inserted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(a)