Regulation (EC) No 726/2004
E23503
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.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Regulation (EC) No 726/2004 canonical | 6 |
How this entity was disambiguated
This entity first appeared as the object of triple T184491 — 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 726/2004 Context triple: [European Medicines Agency, legalBasis, Regulation (EC) No 726/2004]
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A.
Treaty on the Functioning of the European Union
The Treaty on the Functioning of the European Union is one of the EU’s primary founding treaties, setting out its institutional framework, policy competences, and detailed rules governing the functioning of the Union’s internal market and other key areas.
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B.
Lisbon Agreement for the Protection of Appellations of Origin and their International Registration
The Lisbon Agreement for the Protection of Appellations of Origin and their International Registration is an international treaty that facilitates the protection of geographical names identifying products with specific qualities or characteristics linked to their place of origin across member countries.
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C.
Statute of the European System of Central Banks and of the European Central Bank
The Statute of the European System of Central Banks and of the European Central Bank is a foundational legal framework of the European Union that defines the structure, mandate, and operational rules of the ECB and national central banks in conducting monetary policy for the euro area.
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D.
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure
The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure is an international agreement that standardizes how deposits of microorganisms are recognized for patent applications, allowing a single deposit at an approved authority to be accepted by all member states.
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E.
World Forum for Harmonization of Vehicle Regulations
The World Forum for Harmonization of Vehicle Regulations is a United Nations working party that develops and updates international technical standards to ensure the safety, environmental performance, and interoperability of motor vehicles and their equipment.
- 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 726/2004 Target entity description: 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.
-
A.
Treaty on the Functioning of the European Union
The Treaty on the Functioning of the European Union is one of the EU’s primary founding treaties, setting out its institutional framework, policy competences, and detailed rules governing the functioning of the Union’s internal market and other key areas.
-
B.
Lisbon Agreement for the Protection of Appellations of Origin and their International Registration
The Lisbon Agreement for the Protection of Appellations of Origin and their International Registration is an international treaty that facilitates the protection of geographical names identifying products with specific qualities or characteristics linked to their place of origin across member countries.
-
C.
Statute of the European System of Central Banks and of the European Central Bank
The Statute of the European System of Central Banks and of the European Central Bank is a foundational legal framework of the European Union that defines the structure, mandate, and operational rules of the ECB and national central banks in conducting monetary policy for the euro area.
-
D.
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure
The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure is an international agreement that standardizes how deposits of microorganisms are recognized for patent applications, allowing a single deposit at an approved authority to be accepted by all member states.
-
E.
World Forum for Harmonization of Vehicle Regulations
The World Forum for Harmonization of Vehicle Regulations is a United Nations working party that develops and updates international technical standards to ensure the safety, environmental performance, and interoperability of motor vehicles and their equipment.
- F. None of above. chosen
Statements (47)
| Predicate | Object |
|---|---|
| instanceOf |
EU pharmaceutical law
ⓘ
European Union regulation ⓘ |
| allows | optional use of the centralised procedure for certain other innovative products ⓘ |
| amends | rules of EU pharmaceutical acquis predating 2004 ⓘ |
| appliesTo |
medicinal products for human use
ⓘ
veterinary medicinal products ⓘ |
| assignsResponsibilityTo | European Medicines Agency for scientific evaluation of marketing authorisation applications ⓘ |
| defines |
procedures for scientific opinions of the European Medicines Agency
ⓘ
scope of products subject to the centralised procedure ⓘ tasks of the scientific committees of the European Medicines Agency ⓘ |
| definesPowersOf | European Medicines Agency ⓘ |
| definesRoleOf | European Medicines Agency ⓘ |
| establishes |
Committee for Medicinal Products for Human Use
ⓘ
surface form:
Committee for Medicinal Products for Human Use within the European Medicines Agency
Committee for Medicinal Products for Veterinary Use ⓘ
surface form:
Committee for Medicinal Products for Veterinary Use within the European Medicines Agency
Committee for Orphan Medicinal Products ⓘ
surface form:
Committee for Orphan Medicinal Products within the European Medicines Agency
Pharmacovigilance Risk Assessment Committee within the European Medicines Agency ⓘ centralised procedure for the authorisation of medicinal products ⓘ fees payable to the European Medicines Agency ⓘ obligations for Member States regarding supervision of centrally authorised products ⓘ obligations for marketing authorisation holders of centrally authorised products ⓘ procedures for pharmacovigilance of centrally authorised medicinal products ⓘ rules for renewal, suspension and revocation of EU marketing authorisations ⓘ rules for supervision of medicinal products authorised by the EU centralised procedure ⓘ rules on the use of languages in marketing authorisation procedures ⓘ rules on transparency and public access to information on authorised medicinal products ⓘ |
| isImplementedBy | European Commission implementing measures ⓘ |
| isInterpretedBy |
Court of Justice of the European Union
ⓘ
surface form:
Court of Justice of the European Union case law
|
| jurisdiction | European Union ⓘ |
| language | all official languages of the European Union ⓘ |
| legalBasisFor | centralised authorisation procedure for medicinal products in the EU ⓘ |
| providesFor |
data protection and market exclusivity periods for centrally authorised products
ⓘ
granting of EU-wide marketing authorisations by the European Commission ⓘ post-authorisation efficacy studies ⓘ post-authorisation safety studies ⓘ referral procedures for the re-examination of scientific opinions ⓘ suspension of marketing authorisations in case of safety concerns ⓘ urgent safety restrictions for centrally authorised products ⓘ variation procedures for centrally authorised marketing authorisations ⓘ |
| regulates |
authorisation of medicinal products for human use
ⓘ
authorisation of veterinary medicinal products ⓘ |
| requires |
centralised procedure for certain biotechnology-derived medicinal products
ⓘ
centralised procedure for certain new active substances ⓘ centralised procedure for orphan medicinal products ⓘ risk management systems for certain medicinal products ⓘ single EU-wide marketing authorisation for centrally authorised products ⓘ |
| subjectMatter |
authorisation and supervision of medicinal products
ⓘ
role and functioning of the European Medicines Agency ⓘ |
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 726/2004 Description of subject: 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.
Referenced by (6)
Full triples — surface form annotated when it differs from this entity's canonical label.
Pharmacovigilance Risk Assessment Committee within the European Medicines Agency
→
legalBasis
→
Regulation (EC) No 726/2004
ⓘ
subject surface form:
Pharmacovigilance Risk Assessment Committee
subject surface form:
Committee for Advanced Therapies