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Chapter 3 Recording, reporting and assessment of pharmacovigilance dataF1

United Kingdom

Original text. Later amendments are not shown.

  1. 1Recording and reporting of suspected adverse reactions
  2. 2Periodic safety update reports
  3. 3Signal detection
  4. 4Urgent Union procedure
  5. 5Publication of assessments

Annotations

Textual amendments

F1

Substituted by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance).