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 |
How this entity was disambiguated
This entity first appeared as the object of triple T6070092 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
Target entity: Directive 2004/24/EC Context triple: [HMPC, underLegalFramework, Directive 2004/24/EC]
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A.
Directive 2003/41/EC
Directive 2003/41/EC was the original EU framework setting prudential and supervision rules for institutions for occupational retirement provision (IORPs) before being updated and replaced by the IORP II Directive.
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B.
Directive 2009/147/EC
Directive 2009/147/EC is a key European Union law on the conservation of wild birds, forming one of the main legal pillars of the Natura 2000 protected areas network.
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C.
Directive 2001/82/EC
Directive 2001/82/EC is a key European Union law that sets out the rules for the authorization, supervision, and pharmacovigilance of veterinary medicinal products across EU member states.
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D.
Directive 2001/83/EC
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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E.
Council Directive 2001/86/EC
Council Directive 2001/86/EC is a European Union legal act that supplements the Statute for a European Company (Societas Europaea) by establishing rules on employee involvement in such companies.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
Target entity: Directive 2004/24/EC Target entity description: 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.
-
A.
Directive 2003/41/EC
Directive 2003/41/EC was the original EU framework setting prudential and supervision rules for institutions for occupational retirement provision (IORPs) before being updated and replaced by the IORP II Directive.
-
B.
Directive 2009/147/EC
Directive 2009/147/EC is a key European Union law on the conservation of wild birds, forming one of the main legal pillars of the Natura 2000 protected areas network.
-
C.
Directive 2001/82/EC
Directive 2001/82/EC is a key European Union law that sets out the rules for the authorization, supervision, and pharmacovigilance of veterinary medicinal products across EU member states.
-
D.
Directive 2001/83/EC
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.
-
E.
Council Directive 2001/86/EC
Council Directive 2001/86/EC is a European Union legal act that supplements the Statute for a European Company (Societas Europaea) by establishing rules on employee involvement in such companies.
- F. None of above. chosen
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 ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Subject: Directive 2004/24/EC Description of subject: 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.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.