Regulation (EU) 2019/5 of the European Parliament and of the Council of 11 December 2018 amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Regulation (EC) No 1901/2006 on medicinal products for paediatric use and Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance)
Basic information
Dates Date of document:
  • December 11, 2018
Date of publication:
  • January 7, 2019
Date of effect:
  • January 27, 2019
    • Entry into force - Date pub. +20 See Art 5
  • January 28, 2019
    • Application - Partial application See Art 5
  • January 28, 2022
    • Application - Partial application See Art 5
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)
EuroVoc Vocabulary
  • Public health
  • European Medicines Agency
  • Veterinary medicinal product
  • Health control
  • Market approval
  • Marketing standard
  • Veterinary legislation
  • Drug surveillance
  • Animal health and zootechnics
  • Proprietary medicinal products
  • Veterinary inspection
  • Medicinal product