Regulation (EC) No 1902/2006 amending Regulation (EC) No 1901/2006
E553864
Regulation (EC) No 1902/2006 is a European Union legislative act that revises and supplements the original Paediatric Regulation (EC) No 1901/2006, refining the legal framework for the development and authorisation of medicines for children.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Regulation (EC) No 1902/2006 amending Regulation (EC) No 1901/2006 canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T5873278 — 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 (EC) No 1902/2006 amending Regulation (EC) No 1901/2006 Context triple: [PDCO, legalBasis, Regulation (EC) No 1902/2006 amending Regulation (EC) No 1901/2006]
-
A.
Regulation (EC) No 294/2008
Regulation (EC) No 294/2008 is the EU legislative act that established the European Institute of Innovation and Technology and set out its mission, structure, and operating framework.
-
B.
Regulation (EC) No 726/2004
Regulation (EC) No 726/2004 is an EU law that establishes the centralized procedure for the authorization and supervision of medicinal products and defines the role and powers of the European Medicines Agency.
-
C.
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.
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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.
Council Regulation (EEC) No 1210/90
Council Regulation (EEC) No 1210/90 is the European Union legal act that established the European Environment Agency and set out its mandate and operational framework.
- 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 (EC) No 1902/2006 amending Regulation (EC) No 1901/2006 Target entity description: Regulation (EC) No 1902/2006 is a European Union legislative act that revises and supplements the original Paediatric Regulation (EC) No 1901/2006, refining the legal framework for the development and authorisation of medicines for children.
-
A.
Regulation (EC) No 294/2008
Regulation (EC) No 294/2008 is the EU legislative act that established the European Institute of Innovation and Technology and set out its mission, structure, and operating framework.
-
B.
Regulation (EC) No 726/2004
Regulation (EC) No 726/2004 is an EU law that establishes the centralized procedure for the authorization and supervision of medicinal products and defines the role and powers of the European Medicines Agency.
-
C.
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.
-
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.
Council Regulation (EEC) No 1210/90
Council Regulation (EEC) No 1210/90 is the European Union legal act that established the European Environment Agency and set out its mandate and operational framework.
- F. None of above. chosen
Statements (43)
| Predicate | Object |
|---|---|
| instanceOf | European Union regulation ⓘ |
| adoptedBy |
Council of the European Union
NERFINISHED
ⓘ
European Parliament NERFINISHED ⓘ |
| aimsToImprove |
availability of authorised medicines for children
ⓘ
quality of paediatric clinical research ⓘ |
| aimsToProtect | children as patients ⓘ |
| amends | Regulation (EC) No 1901/2006 NERFINISHED ⓘ |
| appliesTo | EU Member States NERFINISHED ⓘ |
| belongsTo | EU secondary legislation ⓘ |
| bindingNature | directly applicable in all Member States ⓘ |
| clarifies |
provisions on incentives and rewards for paediatric studies
ⓘ
provisions on paediatric investigation plans ⓘ |
| concerns |
authorisation of paediatric medicines
ⓘ
development of paediatric medicines ⓘ pharmacovigilance for paediatric use medicines ⓘ |
| dateOfAdoption | 2006-12-20 ⓘ |
| field |
EU health law
ⓘ
EU medicines regulation NERFINISHED ⓘ |
| fullTitle | Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation (EC) No 1901/2006 on medicinal products for paediatric use NERFINISHED ⓘ |
| geographicalScope | European Economic Area NERFINISHED ⓘ |
| jurisdiction | European Union ⓘ |
| languageOfPublication | all official EU languages ⓘ |
| legalBasis | Treaty establishing the European Community NERFINISHED ⓘ |
| legalCitation | Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 NERFINISHED ⓘ |
| legalForm | regulation of the European Parliament and of the Council ⓘ |
| objective |
to refine the legal framework for the development and authorisation of medicines for children in the EU
ⓘ
to supplement and clarify provisions of Regulation (EC) No 1901/2006 ⓘ |
| partOf | EU pharmaceutical acquis ⓘ |
| policyArea |
medicines for children
ⓘ
pharmaceutical regulation ⓘ public health ⓘ |
| refines | procedural rules introduced by Regulation (EC) No 1901/2006 ⓘ |
| regulates |
conditions for marketing authorisation of paediatric medicines
ⓘ
requirements for paediatric medicinal product development in the EU ⓘ |
| relatedInstrument | Regulation (EC) No 1901/2006 on medicinal products for paediatric use NERFINISHED ⓘ |
| relatedTo | Paediatric Regulation NERFINISHED ⓘ |
| sector |
medicinal products
ⓘ
pharmaceutical industry ⓘ |
| shortName | Paediatric Regulation amending act ⓘ |
| status | in force (subject to later amendments) ⓘ |
| subjectMatter | medicinal products for paediatric use ⓘ |
| typeOfAct | regulation ⓘ |
| yearOfAdoption | 2006 ⓘ |
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 (EC) No 1902/2006 amending Regulation (EC) No 1901/2006 Description of subject: Regulation (EC) No 1902/2006 is a European Union legislative act that revises and supplements the original Paediatric Regulation (EC) No 1901/2006, refining the legal framework for the development and authorisation of medicines for children.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.