Regulation (EC) No 726/2004
E23503
Regulation (EC) No 726/2004 is an EU law that establishes the centralized procedure for the authorization and supervision of medicinal products and defines the role and powers of the European Medicines Agency.
Statements (47)
| Predicate | Object |
|---|---|
| instanceOf |
EU pharmaceutical law
→
European Union regulation → |
| allows |
optional use of the centralised procedure for certain other innovative products
→
|
| amends |
rules of EU pharmaceutical acquis predating 2004
→
|
| appliesTo |
medicinal products for human use
→
veterinary medicinal products → |
| assignsResponsibilityTo |
European Medicines Agency for scientific evaluation of marketing authorisation applications
→
|
| defines |
procedures for scientific opinions of the European Medicines Agency
→
scope of products subject to the centralised procedure → tasks of the scientific committees of the European Medicines Agency → |
| definesPowersOf |
European Medicines Agency
→
|
| definesRoleOf |
European Medicines Agency
→
|
| establishes |
Committee for Medicinal Products for Human Use within the European Medicines Agency
→
Committee for Medicinal Products for Veterinary Use within the European Medicines Agency → Committee for Orphan Medicinal Products within the European Medicines Agency → Pharmacovigilance Risk Assessment Committee within the European Medicines Agency → centralised procedure for the authorisation of medicinal products → fees payable to the European Medicines Agency → obligations for Member States regarding supervision of centrally authorised products → obligations for marketing authorisation holders of centrally authorised products → procedures for pharmacovigilance of centrally authorised medicinal products → rules for renewal, suspension and revocation of EU marketing authorisations → rules for supervision of medicinal products authorised by the EU centralised procedure → rules on the use of languages in marketing authorisation procedures → rules on transparency and public access to information on authorised medicinal products → |
| isImplementedBy |
European Commission implementing measures
→
|
| isInterpretedBy |
Court of Justice of the European Union case law
→
|
| jurisdiction |
European Union
→
|
| language |
all official languages of the European Union
→
|
| legalBasisFor |
centralised authorisation procedure for medicinal products in the EU
→
|
| providesFor |
data protection and market exclusivity periods for centrally authorised products
→
granting of EU-wide marketing authorisations by the European Commission → post-authorisation efficacy studies → post-authorisation safety studies → referral procedures for the re-examination of scientific opinions → suspension of marketing authorisations in case of safety concerns → urgent safety restrictions for centrally authorised products → variation procedures for centrally authorised marketing authorisations → |
| regulates |
authorisation of medicinal products for human use
→
authorisation of veterinary medicinal products → |
| requires |
centralised procedure for certain biotechnology-derived medicinal products
→
centralised procedure for certain new active substances → centralised procedure for orphan medicinal products → risk management systems for certain medicinal products → single EU-wide marketing authorisation for centrally authorised products → |
| subjectMatter |
authorisation and supervision of medicinal products
→
role and functioning of the European Medicines Agency → |
Referenced by (1)
| Subject (surface form when different) | Predicate |
|---|---|
|
European Medicines Agency
→
|
legalBasis |