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| Luxembourg night-workers ... |
Good news! The reasoned order must have been uploaded by the Curia Fairies overnight, since it's now available online here. For the record, the CJEU ruled in that order as follows:
"In the context of the European Economic Area (EEA), Article 13(1) of Regulation ... 469/2009 [on SPCs] must be interpreted as meaning that an administrative authorisation issued for a medicinal product by the Swiss Institute for Medicinal Products (SwissMedic), which is automatically recognised in Liechtenstein, must be regarded as the first authorisation to place that medicinal product on the market within the meaning of that provision in the European Economic Area where that authorisation predates marketing authorisations issued for the same medicinal product, either by the European Medicines Agency (EMA), or by the competent authorities of European Union Member States in accordance with the requirements laid down in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, and with the requirements of the Republic of Iceland and the Kingdom of Norway. The fact that, on the basis of similar clinical data, the European Medicines Agency, unlike the Swiss authority, refused to grant a marketing authorisation for that medicinal product at the conclusion of its examination of those data, or the fact that the Swiss authorisation to place the product on the market was suspended by the Swiss Institute for Medicinal Products and subsequently reinstated by the latter only when the holder of the authorisation submitted additional data to it are irrelevant".Further good news is that the reasoned order in Case C-210/13 Glaxosmithkline is now also miraculously available online. A big thank-you to the Curia Fairies for working their magic spells last night ...
1 comment:
No real fairy tell...orders are often put online a week after their notification to the parties. It was the same with the previous SPC cases. Here, they have the same date, so they ve been put online the same day.
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