Regulation (EC) No 1394/2007
E559101
Regulation (EC) No 1394/2007 is the core EU legal framework governing advanced therapy medicinal products such as gene, cell, and tissue-engineered therapies, setting specific rules for their authorization, supervision, and pharmacovigilance.
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
European Union regulation
ⓘ
pharmaceutical law ⓘ |
| adoptedBy |
Council of the European Union
NERFINISHED
ⓘ
European Parliament NERFINISHED ⓘ |
| amends |
Directive 2001/83/EC
NERFINISHED
ⓘ
Regulation (EC) No 726/2004 NERFINISHED ⓘ |
| appliesTo |
advanced therapy medicinal products
ⓘ
combined advanced therapy medicinal products ⓘ gene therapy medicinal products ⓘ somatic cell therapy medicinal products ⓘ tissue engineered products ⓘ |
| assignsRoleTo |
Committee for Advanced Therapies
NERFINISHED
ⓘ
European Medicines Agency NERFINISHED ⓘ |
| basedOn | Article 95 of the EC Treaty ⓘ |
| complements |
Directive 2001/83/EC on the Community code relating to medicinal products for human use
NERFINISHED
ⓘ
Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products NERFINISHED ⓘ |
| containsDefinitionOf |
advanced therapy medicinal product
ⓘ
combined advanced therapy medicinal product ⓘ gene therapy medicinal product ⓘ somatic cell therapy medicinal product ⓘ tissue engineered product ⓘ |
| coreFrameworkFor | EU regulation of advanced therapy medicinal products ⓘ |
| establishes |
a centralized marketing authorization procedure for advanced therapy medicinal products
ⓘ
requirements for quality, safety and efficacy of advanced therapy medicinal products ⓘ specific rules for advanced therapy medicinal products ⓘ the Committee for Advanced Therapies NERFINISHED ⓘ |
| jurisdiction | European Union ⓘ |
| language |
English
ⓘ
all official languages of the European Union ⓘ |
| legalArea |
health law
ⓘ
medicinal products regulation ⓘ pharmaceutical regulation ⓘ |
| objective |
to ensure a high level of health protection for patients using advanced therapy medicinal products
ⓘ
to facilitate the internal market for advanced therapy medicinal products ⓘ to foster innovation in gene, cell and tissue‑engineered therapies ⓘ |
| officialName | Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products NERFINISHED ⓘ |
| regulates |
authorization of advanced therapy medicinal products
ⓘ
hospital exemption for certain advanced therapy medicinal products ⓘ labelling and package leaflet of advanced therapy medicinal products ⓘ pharmacovigilance of advanced therapy medicinal products ⓘ post‑authorization safety monitoring of advanced therapy medicinal products ⓘ risk management systems for advanced therapy medicinal products ⓘ supervision of advanced therapy medicinal products ⓘ traceability requirements for advanced therapy medicinal products ⓘ |
| requires | centralized evaluation of advanced therapy medicinal products by the European Medicines Agency ⓘ |
| scope |
advanced therapy medicinal products intended to be placed on the market in Member States
ⓘ
industrial‑scale manufacture of advanced therapy medicinal products ⓘ |
| subjectOf | European Union pharmaceutical legislation ⓘ |
Referenced by (1)
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