Regulation (EC) No 141/2000 on orphan medicinal products
E546469
Regulation (EC) No 141/2000 on orphan medicinal products is a key European Union law that establishes incentives and a special approval framework to encourage the development and marketing of medicines for rare diseases.
All labels observed (2)
| Label | Occurrences |
|---|---|
| European Union orphan medicinal product regulation | 1 |
| Regulation (EC) No 141/2000 on orphan medicinal products canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T5793351 — 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 on orphan medicinal products Context triple: [COMP, usesLegalBasis, Regulation (EC) No 141/2000 on orphan medicinal products]
-
A.
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.
-
B.
Orphan Drug Act of 1983
The Orphan Drug Act of 1983 is a U.S. law that incentivizes the development of treatments for rare diseases by offering benefits such as market exclusivity, tax credits, and research grants to drug manufacturers.
-
C.
Committee for Orphan Medicinal Products
The Committee for Orphan Medicinal Products is a specialized expert body that evaluates and advises on the designation and development of medicines for rare diseases within the European Union.
-
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 (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.
- 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 on orphan medicinal products Target entity description: Regulation (EC) No 141/2000 on orphan medicinal products is a key European Union law that establishes incentives and a special approval framework to encourage the development and marketing of medicines for rare diseases.
-
A.
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.
-
B.
Orphan Drug Act of 1983
The Orphan Drug Act of 1983 is a U.S. law that incentivizes the development of treatments for rare diseases by offering benefits such as market exclusivity, tax credits, and research grants to drug manufacturers.
-
C.
Committee for Orphan Medicinal Products
The Committee for Orphan Medicinal Products is a specialized expert body that evaluates and advises on the designation and development of medicines for rare diseases within the European Union.
-
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 (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.
- F. None of above. chosen
Statements (47)
| Predicate | Object |
|---|---|
| instanceOf |
European Union regulation
ⓘ
orphan medicinal products legislation ⓘ |
| adoptedBy |
Council of the European Union
NERFINISHED
ⓘ
European Parliament NERFINISHED ⓘ |
| adoptionYear | 1999 ⓘ |
| aimsTo |
encourage development of medicines for rare diseases
ⓘ
ensure availability of treatments for patients with rare conditions ⓘ facilitate placing on the market of orphan medicinal products ⓘ |
| appliesTo |
all EU Member States
ⓘ
human medicinal products ⓘ |
| cameIntoForceYear | 2000 ⓘ |
| criterionIncludes |
lack of sufficient return on investment without incentives
ⓘ
prevalence threshold for rare diseases in the EU ⓘ requirement of significant benefit over existing methods ⓘ |
| defines |
concept of orphan medicinal product in the EU
ⓘ
criteria for orphan designation in the EU ⓘ rules for maintenance and withdrawal of orphan designation ⓘ rules for transfer of orphan designation ⓘ |
| establishes |
10-year market exclusivity for authorised orphan medicinal products
ⓘ
Committee for Orphan Medicinal Products NERFINISHED ⓘ Community register of orphan medicinal products NERFINISHED ⓘ conditions for reduction of market exclusivity period ⓘ procedure for orphan designation applications ⓘ rules on information exchange and transparency for orphan medicinal products ⓘ |
| implementedBy |
Committee for Orphan Medicinal Products
NERFINISHED
ⓘ
European Medicines Agency NERFINISHED ⓘ |
| jurisdiction | European Union ⓘ |
| language | all official languages of the European Union ⓘ |
| legalBasisFor |
centralised procedure for orphan medicinal products in the EU
ⓘ
designation of orphan medicinal products in the EU ⓘ fee reductions for orphan medicinal products in the EU ⓘ incentives for development of orphan medicinal products ⓘ market exclusivity for orphan medicinal products in the EU ⓘ protocol assistance for orphan medicinal products in the EU ⓘ |
| legalForm | Regulation (EC) NERFINISHED ⓘ |
| monitoredBy | European Commission NERFINISHED ⓘ |
| number | 141/2000 ⓘ |
| policyArea |
pharmaceutical regulation
ⓘ
public health ⓘ rare disease policy ⓘ |
| provides |
market exclusivity incentives for orphan medicinal products
ⓘ
regulatory fee reductions for orphan medicinal products ⓘ scientific advice incentives for orphan medicinal products ⓘ |
| relatedTo |
EU pharmaceutical legislation
NERFINISHED
ⓘ
centralised marketing authorisation procedure in the EU ⓘ |
| subjectMatter |
orphan medicinal products
ⓘ
rare diseases ⓘ |
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 on orphan medicinal products Description of subject: Regulation (EC) No 141/2000 on orphan medicinal products is a key European Union law that establishes incentives and a special approval framework to encourage the development and marketing of medicines for rare diseases.
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.
this entity surface form:
European Union orphan medicinal product regulation