Directive 2001/83/EC

E553846

EU pharmaceutical legislation European Union directive

Directive 2001/83/EC is a key European Union law that sets the framework for the authorization, manufacture, distribution, and pharmacovigilance of medicinal products for human use across EU member states.

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Statements (50)

Predicate	Object
instanceOf	EU pharmaceutical legislation ⓘ European Union directive ⓘ
adoptedBy	Council of the European Union NERFINISHED ⓘ European Parliament NERFINISHED ⓘ
aimsTo	ensure a high level of public health protection ⓘ facilitate the free movement of medicinal products within the EU ⓘ
amendedBy	Directive 2002/98/EC NERFINISHED ⓘ Directive 2003/63/EC NERFINISHED ⓘ Directive 2004/24/EC NERFINISHED ⓘ Directive 2004/27/EC NERFINISHED ⓘ Directive 2010/84/EU NERFINISHED ⓘ Directive 2011/62/EU NERFINISHED ⓘ Directive 2012/26/EU NERFINISHED ⓘ
appliesTo	medicinal products for human use ⓘ
dateAdopted	2001-11-06 ⓘ
defines	conditions for granting marketing authorisations ⓘ pharmacovigilance obligations for marketing authorisation holders ⓘ pharmacovigilance obligations for member states ⓘ requirements for efficacy of medicinal products ⓘ requirements for quality of medicinal products ⓘ requirements for safety of medicinal products ⓘ
enteredIntoForce	2001 ⓘ
establishes	Community code for medicinal products for human use NERFINISHED ⓘ
fullName	Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use NERFINISHED ⓘ
harmonises	national rules on medicinal products for human use in EU member states ⓘ
hasScope	EU member states ⓘ
implementedBy	national legislation of EU member states ⓘ
jurisdiction	European Union ⓘ
language	all official languages of the European Union ⓘ
legalArea	medicinal products for human use ⓘ pharmaceutical law ⓘ
legalBasis	Treaty establishing the European Community NERFINISHED ⓘ
recastOf	earlier EU pharmaceutical directives on medicinal products for human use ⓘ
regulates	advertising of medicinal products for human use ⓘ authorization of medicinal products for human use ⓘ distribution of medicinal products for human use ⓘ labelling of medicinal products for human use ⓘ manufacture of medicinal products for human use ⓘ package leaflets for medicinal products for human use ⓘ pharmacovigilance of medicinal products for human use ⓘ pharmacovigilance systems of marketing authorisation holders ⓘ pharmacovigilance systems of member states ⓘ wholesale distribution of medicinal products for human use ⓘ
relatedTo	European Medicines Agency NERFINISHED ⓘ Regulation (EC) No 726/2004 NERFINISHED ⓘ
requires	marketing authorisation for placing medicinal products on the market ⓘ
shortName	Community code relating to medicinal products for human use ⓘ
subjectMatter	pharmacovigilance of medicinal products for human use ⓘ placing medicinal products for human use on the market ⓘ supervision of medicinal products for human use ⓘ

Referenced by (4)

Full triples — surface form annotated when it differs from this entity's canonical label.

European Union pharmaceutical legislation → includes → Directive 2001/83/EC ⓘ

Pharmacovigilance Risk Assessment Committee within the European Medicines Agency → legalBasis → Directive 2001/83/EC ⓘ

subject surface form: Pharmacovigilance Risk Assessment Committee

Paediatric Regulation → relatedTo → Directive 2001/83/EC ⓘ

HMPC → underLegalFramework → Directive 2001/83/EC ⓘ