Regulation (EC) No 1901/2006
E563353
Regulation (EC) No 1901/2006 is the European Union’s Paediatric Regulation, establishing rules to ensure that medicines for children are researched, developed, and authorized to the same high standards as those for adults.
Statements (49)
| Predicate | Object |
|---|---|
| instanceOf |
EU paediatric regulation
ⓘ
European Union regulation ⓘ |
| abbreviation | PUMA for paediatric use marketing authorisation ⓘ |
| adoptedBy |
Council of the European Union
NERFINISHED
ⓘ
European Parliament NERFINISHED ⓘ |
| adoptionDate | 2006-12-12 ⓘ |
| aimsToPrevent |
delays in authorisation of medicines for adults
ⓘ
unnecessary clinical trials in children ⓘ |
| amends |
Directive 2001/83/EC
NERFINISHED
ⓘ
Regulation (EEC) No 1768/92 NERFINISHED ⓘ |
| appliesTo |
medicinal products for human use
ⓘ
paediatric population ⓘ |
| contains |
requirements for labelling and package information for paediatric medicines
ⓘ
requirements for paediatric clinical trials ⓘ requirements for pharmacovigilance in paediatric use ⓘ |
| definesTerm | paediatric population ⓘ |
| entryIntoForceDate | 2007-01-26 ⓘ |
| establishesBody | Paediatric Committee NERFINISHED ⓘ |
| geographicalScope | all EU Member States ⓘ |
| introducesInstrument | paediatric investigation plan ⓘ |
| jurisdiction | European Union ⓘ |
| languageOfTitle | all official EU languages ⓘ |
| legalBasis | Treaty establishing the European Community NERFINISHED ⓘ |
| legalNature | directly applicable in all EU Member States ⓘ |
| mainObjective | to improve the health of children in the European Union ⓘ |
| monitoredBy |
European Medicines Agency
NERFINISHED
ⓘ
national competent authorities of Member States ⓘ |
| objective |
to ensure that medicines for children are appropriately authorised
ⓘ
to ensure that medicines used to treat children are subject to high quality research ⓘ to improve information on medicines for children ⓘ |
| officialName | Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use NERFINISHED ⓘ |
| OJIssuesNumber | 378 ⓘ |
| OJPublicationDate | 2006-12-27 ⓘ |
| OJSeries | L ⓘ |
| PaediatricCommitteeAbbreviation | PDCO NERFINISHED ⓘ |
| PaediatricCommitteeHostedBy | European Medicines Agency NERFINISHED ⓘ |
| paediatricPopulationAgeRange | 0 to 18 years ⓘ |
| policyArea |
pharmaceuticals
ⓘ
public health ⓘ |
| providesIncentive |
paediatric use marketing authorisation
ⓘ
six-month extension of the supplementary protection certificate ⓘ two-year extension of orphan market exclusivity ⓘ |
| publishedIn | Official Journal of the European Union NERFINISHED ⓘ |
| relatedTo |
clinical trials in children
ⓘ
orphan medicinal products ⓘ |
| requires | paediatric investigation plan for most new marketing authorisation applications ⓘ |
| requiresComplianceFrom | pharmaceutical companies ⓘ |
| shortName | Paediatric Regulation NERFINISHED ⓘ |
| subjectToEvaluation | European Commission reviews ⓘ |
Referenced by (1)
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