Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance
Basic information
Dates Date of document:
  • April 16, 2014
Date of publication:
  • May 27, 2014
Date of effect:
  • January 1, 1001
    • Application - See Art 99
  • June 16, 2014
    • Entry into force - Date pub. +20 See Art 99
Deadline:
  • January 1, 1001
    • December 31, 2024
      • See Art 61.1
    Modified by
    Corrected by:
    Modified by:
    Amendment proposed by:
    Completed by:
    All documents based on this document:
    Modifies
    Modifies:
    Repeal:
    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 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)
    • 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)
    EuroVoc Vocabulary
    • Research and technological development
    • Health control
    • Testing
    • Bio-ethics
    • Medicinal product
    • Proprietary medicinal products
    • Medicinal products
    • Health protection
    • Internal market - Principles
    • Market approval
    • Public health
    • Medical research
    • Experiment on humans