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.
Observed surface forms (1)
| Surface form | Occurrences |
|---|---|
| European Union orphan medicinal product regulation | 1 |
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 ⓘ |
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