Keywords

• Appeal
• Medicinal products for human use
• Directive 2001/83/EC
• Marketing authorisation
• Regulation (EEC) No 2309/93
• Centralised procedure at EU 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
• Second subparagraph of Article 6(1) and Article 10(1)
• Concept of a ‘global marketing authorisation’
• Regulatory data protection period.