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 (1)
| Label | Occurrences |
|---|---|
| Directive 2004/24/EC canonical | 1 |
Statements (49)
| Predicate | Object |
|---|---|
| instanceOf |
EU pharmaceutical law
ⓘ
European Union directive ⓘ |
| adoptedBy |
Council of the European Union
NERFINISHED
ⓘ
European Parliament NERFINISHED ⓘ |
| 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 NERFINISHED ⓘ |
| amends | Directive 2001/83/EC NERFINISHED ⓘ |
| appliesTo | EU Member States NERFINISHED ⓘ |
| 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 NERFINISHED ⓘ |
| geographicalScope | European Economic Area NERFINISHED ⓘ |
| 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 NERFINISHED ⓘ |
| objective | to approximate national provisions on traditional herbal medicinal products ⓘ |
| partOf | EU acquis communautaire NERFINISHED ⓘ |
| policyArea |
internal market
ⓘ
public health ⓘ |
| providesFor | community herbal monographs prepared by the European Medicines Agency ⓘ |
| publishedIn | Official Journal of the European Union NERFINISHED ⓘ |
| 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 ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.