Regulation (EU) 2019/5
E555035
Regulation (EU) 2019/5 is an EU legislative act that updates and supplements the legal framework governing the European Medicines Agency and the authorization and supervision of medicinal products within the European Union.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Regulation (EU) 2019/5 canonical | 1 |
Statements (46)
| Predicate | Object |
|---|---|
| instanceOf | European Union regulation ⓘ |
| adoptedBy |
Council of the European Union
NERFINISHED
ⓘ
European Parliament NERFINISHED ⓘ |
| aimsTo |
improve functioning of the internal market for medicinal products
ⓘ
streamline procedures for authorisation of medicinal products ⓘ strengthen supervision of medicinal products ⓘ update the legal framework for the European Medicines Agency ⓘ |
| amends |
Directive 2001/83/EC
NERFINISHED
ⓘ
Regulation (EC) No 141/2000 NERFINISHED ⓘ Regulation (EC) No 1901/2006 NERFINISHED ⓘ Regulation (EC) No 726/2004 NERFINISHED ⓘ |
| appliesTo | European Economic Area NERFINISHED ⓘ |
| basedOn | Treaty on the Functioning of the European Union NERFINISHED ⓘ |
| bindingInItsEntirety | true ⓘ |
| concerns |
European Medicines Agency governance
ⓘ
centralised marketing authorisation procedure ⓘ post-authorisation safety monitoring ⓘ regulatory procedures for medicinal products ⓘ |
| directlyApplicableInMemberStates | true ⓘ |
| hasLegalEffectIn | all EU Member States ⓘ |
| jurisdiction | European Union ⓘ |
| languageVersions | all official EU languages ⓘ |
| legalForm | regulation ⓘ |
| partOf | EU pharmaceutical legislation ⓘ |
| policyArea |
health and consumer protection
ⓘ
internal market ⓘ |
| regulates |
coordination between EMA and national authorities
ⓘ
data and information exchange on medicinal products ⓘ obligations of marketing authorisation holders ⓘ procedures for evaluation of medicinal products ⓘ |
| relatedInstrument | Regulation (EU) 2019/6 NERFINISHED ⓘ |
| relatedTo |
EU medicines regulatory network
NERFINISHED
ⓘ
marketing authorisation holders ⓘ |
| requiresComplianceFrom |
marketing authorisation applicants
ⓘ
pharmaceutical companies ⓘ |
| requiresImplementationBy |
EU Member States competent authorities
ⓘ
European Medicines Agency NERFINISHED ⓘ |
| sector |
pharmaceuticals
ⓘ
public health ⓘ |
| subjectMatter |
European Medicines Agency
NERFINISHED
ⓘ
authorization of medicinal products ⓘ human medicinal products ⓘ pharmacovigilance ⓘ supervision of medicinal products ⓘ veterinary medicinal products ⓘ |
| typeOfAct | co-decision act ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.