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SPC Case Law - Astrazeneca AB/Comptroller-General of Patents C-617/12 of Nov. 14, 2013 (Reasoned order)

Question

Is a Swiss MA, which is automatically recognised in Liechtenstein a first MA according to Article 13 (1)?

Answer

A Swiss marketing authorization MA, which is automatically recognised in Liechtenstein, must be regarded as the first MA according to Article 13 (1) of the Regulation to place that medicinal product on the market where that MA predates MAs issued for the same medicinal product, either by the EMA European Medicines Agency, by the competent authorities of European Union Member States, or by the authorities of the Republic of Iceland and the Kingdom of Norway.

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SPC Case Law - Astrazeneca AB/Comptroller-General of Patents C-617/12 of Nov. 14, 2013 (Reasoned order)

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