Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance Text with EEA relevance
Basic information
Dates Date of document:
  • October 25, 2012
Date of publication:
  • October 27, 2012
Date of effect:
  • November 16, 2012
    • Entry into force - Date pub. + 20 See Art 3
  • October 28, 2013
    • Application - See Art 2
Date of transposition:
  • October 28, 2013
    • At the latest See Art 2
Modified by
Modifies
Modifies:
Affected by case
Legal basis
  • Consolidated version of the Treaty on the Functioning of the European Union PART THREE - UNION POLICIES AND INTERNAL ACTIONS TITLE XIV - PUBLIC HEALTH Article 168(ex Article 152 TEC)
  • Consolidated version of the Treaty on the Functioning of the European Union PART THREE - UNION POLICIES AND INTERNAL ACTIONS TITLE VII - COMMON RULES ON COMPETITION, TAXATION AND APPROXIMATION OF LAWS Chapter 3 - Approximation of laws Article 114(ex Article 95 TEC)
  • Consolidated version of the Treaty on the Functioning of the European Union PART SIX - INSTITUTIONAL AND FINANCIAL PROVISIONS TITLE I - INSTITUTIONAL PROVISIONS Chapter 2 - Legal acts of the Union, adoption procedures and other provisions Section 2 - Procedures for the adoption of acts and other provisions Article 294(ex Article 251 TEC)
EuroVoc Vocabulary
  • Medicinal product
  • Drug surveillance
  • Disclosure of information
  • Withdrawal from the market
  • Proprietary medicinal products
  • Marketing standard
  • Consumer information
  • Market approval
  • Public health
  • European Medicines Agency