Directive 2001/83/EC
E553846
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.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Directive 2001/83/EC canonical | 4 |
How this entity was disambiguated
This entity first appeared as the object of triple T5872816 — 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.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: Directive 2001/83/EC Context triple: [European Union pharmaceutical legislation, includes, Directive 2001/83/EC]
-
A.
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.
-
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.
Council Directive 92/43/EEC
Council Directive 92/43/EEC is a key European Union law on the conservation of natural habitats and wild fauna and flora, forming one of the main pillars of EU nature protection policy.
-
D.
Regulation (EC) No 45/2001
Regulation (EC) No 45/2001 is an EU law that sets out data protection rules for the processing of personal data by EU institutions and bodies.
-
E.
Regulation (EC) No 851/2004
Regulation (EC) No 851/2004 is the EU law that established the European Centre for Disease Prevention and Control and defined its mandate, structure, and functions in coordinating infectious disease surveillance and control across member states.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: Directive 2001/83/EC Target entity description: 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.
-
A.
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.
-
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.
Council Directive 92/43/EEC
Council Directive 92/43/EEC is a key European Union law on the conservation of natural habitats and wild fauna and flora, forming one of the main pillars of EU nature protection policy.
-
D.
Regulation (EC) No 45/2001
Regulation (EC) No 45/2001 is an EU law that sets out data protection rules for the processing of personal data by EU institutions and bodies.
-
E.
Regulation (EC) No 851/2004
Regulation (EC) No 851/2004 is the EU law that established the European Centre for Disease Prevention and Control and defined its mandate, structure, and functions in coordinating infectious disease surveillance and control across member states.
- F. None of above. chosen
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 ⓘ |
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.
Instruction
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.
Input
Subject: Directive 2001/83/EC Description of subject: 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.
Referenced by (4)
Full triples — surface form annotated when it differs from this entity's canonical label.
Pharmacovigilance Risk Assessment Committee within the European Medicines Agency
→
legalBasis
→
Directive 2001/83/EC
ⓘ
subject surface form:
Pharmacovigilance Risk Assessment Committee