ECJ (Approximation of Laws Public Health : Judgment) Appeal – Medicinal products for human use – Marketing authorisation – Regulation (EEC) No 2309/93 – Centralised procedure at European Union level – Development of a medicinal product that was the subject of a marketing authorisation for other therapeutic indications – Separate marketing authorisation and new trade name – Directive 2001/83/EC – Second subparagraph of Article 6(1) and Article 10(1) – Concept of a ‘global marketing authorisation’ – Regulatory data protection period
Citations:
C-629/15, [2017] EUECJ C-629/15
Links:
Jurisdiction:
European
Health
Updated: 27 March 2022; Ref: scu.588733
