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Chapter III Minimum requirements for the monitoring of data in the Eudravigilance databaseF1

United Kingdom

Original text. Later amendments are not shown.

  1. 18General requirements
  2. 19Identification of changed risks and new risks
  3. 20Methodology for determining the evidentiary value of a signal
  4. 21Signal management process
  5. 22Worksharing for signal management
  6. 23Signal detection support
  7. 24Signal detection audit trail

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)