|Small country with a|
long name -- and not
significance for SPCs
The first and second questions (at ) are:
""1. Is a Swiss marketing authorisation, not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, but automatically recognised by Liechtenstein, capable of constituting the 'first authorisation to place the product on the market' for the purposes of Article 13(1) of Regulation 469/2009/EC?
2. Does it make a difference to the answer to the first question if:
(a) the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004/EC; and/or
(b) the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data?".The third question (at ) is:
"If Article 13(1) of Regulation 469/2009 refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83/EC render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of Regulation 469/2009?"In his judgment, Arnold J explains both the context within which these questions are being asked and the reasoning behind them.