Directive 2004/24/EC

E567395

Directive 2004/24/EC is a European Union law that created a simplified registration and regulatory framework for traditional herbal medicinal products across EU member states.

All labels observed (2)

How this entity was disambiguated

Statements (49)

Predicate Object
instanceOf EU pharmaceutical law ⓘ
European Union directive ⓘ
adoptedBy Council of the European Union ⓘ
European Parliament ⓘ
adoptionDate 2004-03-31 ⓘ
aimsTo ensure a high level of public health protection ⓘ
facilitate free movement of traditional herbal medicinal products within the EU ⓘ
provide legal certainty for manufacturers of traditional herbal medicinal products ⓘ
alsoKnownAs Traditional Herbal Medicinal Products Directive ⓘ
amends Directive 2001/83/EC ⓘ
appliesTo EU Member States ⓘ
createsFrameworkFor simplified registration of traditional herbal medicinal products ⓘ
defines traditional herbal medicinal product ⓘ
doesNotApplyTo magistral and officinal preparations prepared in pharmacies ⓘ
establishes simplified registration procedure for traditional herbal medicinal products ⓘ
traditional-use registration scheme ⓘ
excludes injectable herbal medicinal products from simplified registration ⓘ
fullName Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 ⓘ
geographicalScope European Economic Area ⓘ
implementedBy national legislation of EU Member States ⓘ
jurisdiction European Union ⓘ
languageVersions all official languages of the European Union ⓘ
legalBasis Article 95 of the EC Treaty ⓘ
legalInstrumentType directive ⓘ
linkedInstitution European Medicines Agency ⓘ
objective to approximate national provisions on traditional herbal medicinal products ⓘ
partOf EU acquis communautaire ⓘ
policyArea internal market ⓘ
public health ⓘ
providesFor community herbal monographs prepared by the European Medicines Agency ⓘ
publishedIn Official Journal of the European Union ⓘ
regulates industrially manufactured traditional herbal medicinal products ⓘ
requires assessment of plausibility of efficacy based on long-standing use and experience ⓘ
harmonised rules for traditional herbal medicinal products in the EU internal market ⓘ
marketing authorisation or registration before placing traditional herbal medicinal products on the market ⓘ
periodic safety update reports for registered products ⓘ
pharmacovigilance for traditional herbal medicinal products ⓘ
requiresComplianceWith good manufacturing practice for traditional herbal medicinal products ⓘ
sector herbal medicines ⓘ
pharmaceutical industry ⓘ
setsRequirement evidence of at least 15 years of traditional use within the European Union ⓘ
evidence of traditional use for at least 30 years ⓘ
pharmaceutical quality standards for traditional herbal medicinal products ⓘ
products must be for oral, external or inhalation use ⓘ
products must be intended and designed for use without the supervision of a medical practitioner ⓘ
safety data for traditional herbal medicinal products ⓘ
specific labelling rules for traditional herbal medicinal products ⓘ
subjectMatter pharmaceutical regulation ⓘ
traditional herbal medicinal products ⓘ

How these facts were elicited

Referenced by (3)

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

HMPC → underLegalFramework → Directive 2004/24/EC ⓘ
Directive 2001/83/EC → amendedBy → Directive 2004/24/EC ⓘ
Directive 2004/24/EC → fullName → Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 ⓘ
linked to: Directive 2004/24/EC