Regulation (EC) No 141/2000
E555033
Regulation (EC) No 141/2000 is the European Union’s core legal framework establishing incentives and procedures for the designation, development, and authorization of orphan medicinal products for rare diseases.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Regulation (EC) No 141/2000 canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T5872820 — 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 141/2000 Context triple: [European Union pharmaceutical legislation, includes, Regulation (EC) No 141/2000]
-
A.
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.
-
B.
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.
-
C.
Council Regulation (EC) No 1/2003
Council Regulation (EC) No 1/2003 is a key European Union law that modernized and decentralized the enforcement of EU competition rules, particularly Articles 101 and 102 of the Treaty on the Functioning of the European Union.
-
D.
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.
-
E.
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.
- 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 141/2000 Target entity description: Regulation (EC) No 141/2000 is the European Union’s core legal framework establishing incentives and procedures for the designation, development, and authorization of orphan medicinal products for rare diseases.
-
A.
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.
-
B.
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.
-
C.
Council Regulation (EC) No 1/2003
Council Regulation (EC) No 1/2003 is a key European Union law that modernized and decentralized the enforcement of EU competition rules, particularly Articles 101 and 102 of the Treaty on the Functioning of the European Union.
-
D.
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.
-
E.
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.
- F. None of above. chosen
Statements (50)
| Predicate | Object |
|---|---|
| instanceOf |
European Union regulation
ⓘ
orphan medicinal products legislation ⓘ |
| abbreviation | COMP for Committee for Orphan Medicinal Products NERFINISHED ⓘ |
| adoptedBy |
Council of the European Union
NERFINISHED
ⓘ
European Parliament NERFINISHED ⓘ |
| allows | withdrawal of orphan designation under certain conditions ⓘ |
| amendedBy | Regulation (EC) No 847/2000 NERFINISHED ⓘ |
| appliesTo | human medicinal products ⓘ |
| dateAdopted | 1999-12-16 ⓘ |
| dateOfEntryIntoForce | 2000-01-22 ⓘ |
| defines |
criteria for orphan designation
ⓘ
incentives for orphan medicinal products ⓘ procedures for marketing authorization of orphan medicinal products ⓘ |
| designationAuthority | European Commission NERFINISHED ⓘ |
| enteredIntoApplication | 2000 ⓘ |
| establishes | Committee for Orphan Medicinal Products NERFINISHED ⓘ |
| EURLexSector | 13.30.10.00 medicinal products ⓘ |
| excludes | veterinary medicinal products ⓘ |
| geographicalScope | European Economic Area for many practical effects ⓘ |
| hasNumbering | 141/2000 ⓘ |
| implementedBy | European Medicines Agency NERFINISHED ⓘ |
| jurisdiction | European Union ⓘ |
| languageVersion | all official languages of the European Union ⓘ |
| legalBasis | Article 95 of the EC Treaty NERFINISHED ⓘ |
| linkedTo | Regulation (EC) No 726/2004 ⓘ |
| marketExclusivityDuration | 10 years ⓘ |
| marketExclusivityException |
can be broken if a second product is clinically superior
ⓘ
can be broken if the original product cannot supply the market ⓘ |
| marketExclusivityReductionCondition | can be reduced to 6 years if criteria are no longer met ⓘ |
| officialName | Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products NERFINISHED ⓘ |
| orphanCriteria |
condition is life-threatening or chronically debilitating
ⓘ
no satisfactory method of diagnosis, prevention or treatment exists or the medicinal product will be of significant benefit ⓘ prevalence of the condition not more than 5 in 10,000 persons in the EU ⓘ |
| policyArea |
pharmaceutical policy
ⓘ
public health ⓘ |
| procedure | sponsor applies for orphan designation before marketing authorisation application ⓘ |
| providesIncentive |
10-year market exclusivity for designated orphan medicinal products
ⓘ
access to EU research funding incentives ⓘ fee reductions for regulatory procedures ⓘ protocol assistance from the European Medicines Agency ⓘ |
| purpose |
to establish a Community procedure for designation of orphan medicinal products
ⓘ
to provide incentives for research, development and placing on the market of orphan medicinal products ⓘ |
| recitalTopic |
need to stimulate research and development for rare diseases
ⓘ
public health needs of patients suffering from rare conditions ⓘ |
| requires | centralised marketing authorisation for orphan medicinal products ⓘ |
| scientificAssessmentBy | Committee for Orphan Medicinal Products NERFINISHED ⓘ |
| shortName | EU Orphan Regulation NERFINISHED ⓘ |
| subjectMatter |
orphan medicinal products
ⓘ
rare diseases ⓘ |
| yearOfAdoption | 1999 ⓘ |
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 141/2000 Description of subject: Regulation (EC) No 141/2000 is the European Union’s core legal framework establishing incentives and procedures for the designation, development, and authorization of orphan medicinal products for rare diseases.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.