Directive 2001/82/EC
E555032
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.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Directive 2001/82/EC canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T5872817 — 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 2001/82/EC Context triple: [European Union pharmaceutical legislation, includes, Directive 2001/82/EC]
-
A.
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.
-
B.
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.
-
C.
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.
-
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.
Directive 2009/138/EC of the European Parliament and of the Council
Directive 2009/138/EC of the European Parliament and of the Council, commonly known as the Solvency II Directive, is the EU’s comprehensive regulatory framework governing the capital adequacy, risk management, and supervisory oversight of insurance and reinsurance companies.
- 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 2001/82/EC Target entity description: 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.
-
A.
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.
-
B.
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.
-
C.
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.
-
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.
Directive 2009/138/EC of the European Parliament and of the Council
Directive 2009/138/EC of the European Parliament and of the Council, commonly known as the Solvency II Directive, is the EU’s comprehensive regulatory framework governing the capital adequacy, risk management, and supervisory oversight of insurance and reinsurance companies.
- F. None of above. chosen
Statements (49)
| Predicate | Object |
|---|---|
| instanceOf |
EU veterinary medicinal products legislation
ⓘ
European Union directive ⓘ |
| adoptedBy |
Council of the European Union
NERFINISHED
ⓘ
European Parliament NERFINISHED ⓘ |
| aimsTo |
ensure a high level of protection of animal health
ⓘ
ensure a high level of protection of public health ⓘ facilitate the free movement of veterinary medicinal products within the EU ⓘ harmonize rules on veterinary medicinal products in the EU ⓘ |
| amendedBy | Directive 2004/28/EC NERFINISHED ⓘ |
| appliesTo | EU Member States NERFINISHED ⓘ |
| contains |
rules on pharmacovigilance reporting obligations
ⓘ
rules on prescribing and dispensing of veterinary medicinal products ⓘ rules on retail supply of veterinary medicinal products ⓘ rules on wholesale distribution of veterinary medicinal products ⓘ |
| defines |
homeopathic veterinary medicinal product
ⓘ
immunological veterinary medicinal product ⓘ veterinary medicinal product ⓘ |
| establishes | Community code relating to veterinary medicinal products NERFINISHED ⓘ |
| fullTitle | Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products NERFINISHED ⓘ |
| jurisdiction | European Union ⓘ |
| languageVersions | all official languages of the European Union ⓘ |
| legalBasis | Treaty establishing the European Community NERFINISHED ⓘ |
| policyArea |
animal health
ⓘ
internal market ⓘ public health ⓘ |
| regulates |
advertising of veterinary medicinal products
ⓘ
distribution of veterinary medicinal products ⓘ import of veterinary medicinal products ⓘ labelling of veterinary medicinal products ⓘ manufacture of veterinary medicinal products ⓘ marketing authorization of veterinary medicinal products ⓘ package leaflets for veterinary medicinal products ⓘ pharmacovigilance systems for veterinary medicinal products ⓘ |
| repealedBy | Regulation (EU) 2019/6 ⓘ |
| repealEffectiveDate | 28 January 2022 ⓘ |
| replacedBy | Regulation (EU) 2019/6 on veterinary medicinal products NERFINISHED ⓘ |
| requires |
Member States to establish pharmacovigilance systems for veterinary medicinal products
NERFINISHED
ⓘ
assessment of quality, safety and efficacy of veterinary medicinal products ⓘ good distribution practice for veterinary medicinal products ⓘ good manufacturing practice for veterinary medicinal products ⓘ manufacturing authorization for producers of veterinary medicinal products ⓘ marketing authorization before placing veterinary medicinal products on the market ⓘ qualified person responsible for pharmacovigilance ⓘ recording and reporting of adverse reactions to veterinary medicinal products ⓘ |
| sector | veterinary medicine ⓘ |
| subjectMatter |
authorization of veterinary medicinal products
ⓘ
pharmacovigilance of veterinary medicinal products ⓘ supervision of veterinary medicinal products ⓘ veterinary 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.
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 2001/82/EC Description of subject: 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.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.