Human Medicines Community Code Directive (Codified)
Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE on the Community code relating to medicinal products for human use (codified version)
- Stage
- In force, reached 28 Nov 2001
- In force
- In force since 18 Dec 2001 · CELEX 32001L0083
- Procedure
- Directive · Ordinary legislative procedure
- Last activity
- 18 Dec 2001
Delegated and implementing acts beneath it
By status: 26 published.
Titles link to EUR-Lex where the act has been published.
Documents
Newest first. Each opens at its source.
- Text adopted · 32003L0063Commission
- Proposal · COM(2016)0498Commission
- Proposal · COM(2017)0135Commission
- Proposal · COM(2021)0497Commission
- Text adopted · Directive 2001/0083Commission
- OJ C 368 20.12.1999, p. 0003Commission
- Text adopted · OJ L 159 27.06.2003, p. 0046-0094Commission
- Text adopted · OJ L 311 28.11.2001, p. 0067Commission
- SEC(2007)1740Commission
- Text adopted · T5-0364/2001Parliament
Summary
GeneratedDirective 2001/83/EC codifies EU rules on medicinal products for human use, covering marketing authorization, manufacturing, distribution, pharmacovigilance, and falsified product controls. It applies to industrially prepared products, with exemptions for pharmacy-prepared and research products.
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Sources: EP Legislative Observatory · EU Law Tracker · EUR-Lex. Record as of 30 Sept 2026. Something wrong on this page? Report an error.
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