1.Article 47a of 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, as amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012, must be interpreted as meaning that provided that all the requirements referred to in that article are satisfied, repackaging in new packaging and relabelling of medicinal products imported in parallel constitute equivalent forms of repackaging as regards the efficacy of the safety features referred to in Article 54(o) of that directive, as amended by Directive 2012/26, without one prevailing over the other. 2.Article 10(2) and Article 15 of Directive (EU) 2015/2436 of the European Parliament and of the Council of 16 December 2015 to approximate the laws of the Member States relating to trade marks must be interpreted as meaning that the trade mark proprietor is entitled to oppose the marketing, by a parallel importer, of a medicinal product repackaged in new outer packaging to which that trade mark is affixed where it is objectively possible to relabel the medicinal product concerned in compliance with the requirements provided for in Article 47a of Directive 2001/83, as amended by Directive 2012/26, and where the medicinal product thus relabelled could actually access the market of the Member State of importation. 3.Article 10(2) and Article 15 of Directive 2015/2436 must be interpreted as meaning that the trade mark proprietor is entitled to oppose the marketing, by a parallel importer, of a medicinal product repackaged in new outer packaging to which that trade mark is affixed, where the visible traces of opening of the original outer packaging which, where applicable, would result from relabelling of that medicinal product would be clearly attributable to the repackaging thus carried out by that parallel importer, unless those traces give rise, on the market of the Member State of importation or on a significant part of that market, to such strong resistance on the part of a significant proportion of consumers to medicinal products repackaged in that way as to constitute a barrier to effective access to that market, which must be established on a case-by-case basis.
