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.
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 ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.