Regulation (EC) No 1902/2006 amending Regulation (EC) No 1901/2006
E553864
Regulation (EC) No 1902/2006 is a European Union legislative act that revises and supplements the original Paediatric Regulation (EC) No 1901/2006, refining the legal framework for the development and authorisation of medicines for children.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Regulation (EC) No 1902/2006 amending Regulation (EC) No 1901/2006 canonical | 1 |
Statements (43)
| Predicate | Object |
|---|---|
| instanceOf | European Union regulation ⓘ |
| adoptedBy |
Council of the European Union
NERFINISHED
ⓘ
European Parliament NERFINISHED ⓘ |
| aimsToImprove |
availability of authorised medicines for children
ⓘ
quality of paediatric clinical research ⓘ |
| aimsToProtect | children as patients ⓘ |
| amends | Regulation (EC) No 1901/2006 NERFINISHED ⓘ |
| appliesTo | EU Member States NERFINISHED ⓘ |
| belongsTo | EU secondary legislation ⓘ |
| bindingNature | directly applicable in all Member States ⓘ |
| clarifies |
provisions on incentives and rewards for paediatric studies
ⓘ
provisions on paediatric investigation plans ⓘ |
| concerns |
authorisation of paediatric medicines
ⓘ
development of paediatric medicines ⓘ pharmacovigilance for paediatric use medicines ⓘ |
| dateOfAdoption | 2006-12-20 ⓘ |
| field |
EU health law
ⓘ
EU medicines regulation NERFINISHED ⓘ |
| fullTitle | Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation (EC) No 1901/2006 on medicinal products for paediatric use NERFINISHED ⓘ |
| geographicalScope | European Economic Area NERFINISHED ⓘ |
| jurisdiction | European Union ⓘ |
| languageOfPublication | all official EU languages ⓘ |
| legalBasis | Treaty establishing the European Community NERFINISHED ⓘ |
| legalCitation | Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 NERFINISHED ⓘ |
| legalForm | regulation of the European Parliament and of the Council ⓘ |
| objective |
to refine the legal framework for the development and authorisation of medicines for children in the EU
ⓘ
to supplement and clarify provisions of Regulation (EC) No 1901/2006 ⓘ |
| partOf | EU pharmaceutical acquis ⓘ |
| policyArea |
medicines for children
ⓘ
pharmaceutical regulation ⓘ public health ⓘ |
| refines | procedural rules introduced by Regulation (EC) No 1901/2006 ⓘ |
| regulates |
conditions for marketing authorisation of paediatric medicines
ⓘ
requirements for paediatric medicinal product development in the EU ⓘ |
| relatedInstrument | Regulation (EC) No 1901/2006 on medicinal products for paediatric use NERFINISHED ⓘ |
| relatedTo | Paediatric Regulation NERFINISHED ⓘ |
| sector |
medicinal products
ⓘ
pharmaceutical industry ⓘ |
| shortName | Paediatric Regulation amending act ⓘ |
| status | in force (subject to later amendments) ⓘ |
| subjectMatter | medicinal products for paediatric use ⓘ |
| typeOfAct | regulation ⓘ |
| yearOfAdoption | 2006 ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.