Regulation (EU) 2019/5
E555035
Regulation (EU) 2019/5 is an EU legislative act that updates and supplements the legal framework governing the European Medicines Agency and the authorization and supervision of medicinal products within the European Union.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Regulation (EU) 2019/5 canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T5873430 — 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: Regulation (EU) 2019/5 Context triple: [Management Board of the European Medicines Agency, legalBasis, Regulation (EU) 2019/5]
-
A.
Regulation (EU) 2019/6
Regulation (EU) 2019/6 is a key EU law that modernizes and harmonizes the rules governing the authorization, use, and monitoring of veterinary medicinal products across Member States.
-
B.
Regulation (EU) 2019/787
Regulation (EU) 2019/787 is a European Union law that harmonizes the rules for the production, labeling, and protection of spirit drinks, including geographical indications such as Protected Designations of Origin.
-
C.
Regulation (EU) 2018/1139
Regulation (EU) 2018/1139 is a key European Union legislative act that establishes the common rules and framework for civil aviation safety and the functioning of the European Union Aviation Safety Agency.
-
D.
Regulation (EU) 2018/1725
Regulation (EU) 2018/1725 is the EU law that sets out data protection rules for EU institutions, bodies, offices and agencies, aligning them with the General Data Protection Regulation (GDPR).
-
E.
Regulation (EU) 2021/819
Regulation (EU) 2021/819 is a European Union legal act that sets out updated rules and provisions governing the structure, mission, and functioning of the European Institute of Innovation and Technology (EIT) and its bodies.
- 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: Regulation (EU) 2019/5 Target entity description: Regulation (EU) 2019/5 is an EU legislative act that updates and supplements the legal framework governing the European Medicines Agency and the authorization and supervision of medicinal products within the European Union.
-
A.
Regulation (EU) 2019/6
Regulation (EU) 2019/6 is a key EU law that modernizes and harmonizes the rules governing the authorization, use, and monitoring of veterinary medicinal products across Member States.
-
B.
Regulation (EU) 2019/787
Regulation (EU) 2019/787 is a European Union law that harmonizes the rules for the production, labeling, and protection of spirit drinks, including geographical indications such as Protected Designations of Origin.
-
C.
Regulation (EU) 2018/1139
Regulation (EU) 2018/1139 is a key European Union legislative act that establishes the common rules and framework for civil aviation safety and the functioning of the European Union Aviation Safety Agency.
-
D.
Regulation (EU) 2018/1725
Regulation (EU) 2018/1725 is the EU law that sets out data protection rules for EU institutions, bodies, offices and agencies, aligning them with the General Data Protection Regulation (GDPR).
-
E.
Regulation (EU) 2021/819
Regulation (EU) 2021/819 is a European Union legal act that sets out updated rules and provisions governing the structure, mission, and functioning of the European Institute of Innovation and Technology (EIT) and its bodies.
- F. None of above. chosen
Statements (46)
| Predicate | Object |
|---|---|
| instanceOf | European Union regulation ⓘ |
| adoptedBy |
Council of the European Union
ⓘ
European Parliament ⓘ |
| aimsTo |
improve functioning of the internal market for medicinal products
ⓘ
streamline procedures for authorisation of medicinal products ⓘ strengthen supervision of medicinal products ⓘ update the legal framework for the European Medicines Agency ⓘ |
| amends |
Directive 2001/83/EC
ⓘ
Regulation (EC) No 141/2000 ⓘ Regulation (EC) No 1901/2006 ⓘ Regulation (EC) No 726/2004 ⓘ |
| appliesTo | European Economic Area ⓘ |
| basedOn | Treaty on the Functioning of the European Union ⓘ |
| bindingInItsEntirety | true ⓘ |
| concerns |
European Medicines Agency governance
ⓘ
centralised marketing authorisation procedure ⓘ post-authorisation safety monitoring ⓘ regulatory procedures for medicinal products ⓘ |
| directlyApplicableInMemberStates | true ⓘ |
| hasLegalEffectIn | all EU Member States ⓘ |
| jurisdiction | European Union ⓘ |
| languageVersions | all official EU languages ⓘ |
| legalForm | regulation ⓘ |
| partOf | EU pharmaceutical legislation ⓘ |
| policyArea |
health and consumer protection
ⓘ
internal market ⓘ |
| regulates |
coordination between EMA and national authorities
ⓘ
data and information exchange on medicinal products ⓘ obligations of marketing authorisation holders ⓘ procedures for evaluation of medicinal products ⓘ |
| relatedInstrument | Regulation (EU) 2019/6 ⓘ |
| relatedTo |
EU medicines regulatory network
ⓘ
linked to:
European medicines regulatory authorities
marketing authorisation holders ⓘ |
| requiresComplianceFrom |
marketing authorisation applicants
ⓘ
pharmaceutical companies ⓘ |
| requiresImplementationBy |
EU Member States competent authorities
ⓘ
European Medicines Agency ⓘ |
| sector |
pharmaceuticals
ⓘ
public health ⓘ |
| subjectMatter |
European Medicines Agency
ⓘ
authorization of medicinal products ⓘ human medicinal products ⓘ pharmacovigilance ⓘ supervision of medicinal products ⓘ veterinary medicinal products ⓘ |
| typeOfAct | co-decision act ⓘ |
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: Regulation (EU) 2019/5 Description of subject: Regulation (EU) 2019/5 is an EU legislative act that updates and supplements the legal framework governing the European Medicines Agency and the authorization and supervision of medicinal products within the European Union.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.