Regulation (EC) No 1902/2006 amending Regulation (EC) No 1901/2006

E553864

European Union regulation

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.

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All labels observed (3)

Label	Occurrences
Regulation (EC) No 1902/2006 amending Regulation (EC) No 1901/2006 canonical	1
Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006	1
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	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.
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 ⓘ European Parliament ⓘ
aimsToImprove	availability of authorised medicines for children ⓘ quality of paediatric clinical research ⓘ
aimsToProtect	children as patients ⓘ
amends	Regulation (EC) No 1901/2006 ⓘ
appliesTo	EU Member States ⓘ linked to: Member States of the European Union
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 ⓘ linked to: European Union pharmaceutical legislation
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 ⓘ linked to: Regulation (EC) No 1902/2006 amending Regulation (EC) No 1901/2006
geographicalScope	European Economic Area ⓘ
jurisdiction	European Union ⓘ
languageOfPublication	all official EU languages ⓘ
legalBasis	Treaty establishing the European Community ⓘ linked to: Treaty of Rome
legalCitation	Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 ⓘ linked to: Regulation (EC) No 1902/2006 amending Regulation (EC) No 1901/2006
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 ⓘ linked to: Regulation (EC) No 1901/2006
relatedTo	Paediatric Regulation ⓘ
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

Referenced by (3)

Full triples — surface form annotated when it differs from this entity's canonical label.

PDCO → legalBasis → Regulation (EC) No 1902/2006 amending Regulation (EC) No 1901/2006 ⓘ

Regulation (EC) No 1902/2006 → 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 ⓘ

subject linked to: Regulation (EC) No 1902/2006 amending Regulation (EC) No 1901/2006

linked to: Regulation (EC) No 1902/2006 amending Regulation (EC) No 1901/2006

Regulation (EC) No 1902/2006 → legalCitation → Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 ⓘ