National Node of the BCH
Law, Regulation or Guideline
Record information and status
Record ID
Date of creation
2011-07-28 13:52 UTC (Guy.VAN-DEN-EEDE@ec.europa.eu)
Date of last update
2019-09-26 09:46 UTC (chantal.bruetschy@ec.europa.eu)
Date of publication
2019-09-26 09:46 UTC (chantal.bruetschy@ec.europa.eu)

General Information
  • European Union
  • European Union
Title of document
Directive 2001/83/EC of the European Parliament and of the Council on the Community Code relating to medicinal products for human use
Legislative details
Type of document
  • Law
Subject areas
  • Competent National Authorities and National Focal Points
  • Pharmaceuticals
  • Risk assessment and management
Types of LMOs addressed
  • All types of organisms
Brief description of the document including objective and scope:
Single text assembling EU regulatory provisions relating to the production, distribution and use of medicinal products
Date of entry into force
Document details
Document text
DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community code relating to medicinal products for human use
Unofficial documents
http:// https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1569490554809&uri=CELEX:02001L0083-20190128
Consolidated version of Directive 2001/83/EC with all its amendments. This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
Regulatory contact information
Contact person
European Commission - Health and Food Safety Directorate General SANTE
Rue Belliard, B232
Belgium, 1040
Phone:+32 2 29 20485
Url:European Commission - Health and Food Safety Directorate General SANTE