Judgment_paragraph 40 · Generics (UK) Ltd and Others v Competition and Markets Authority (C-307/18)

40In that respect, first, as regards, as in the main proceedings, the pharmaceutical sector, the specific features of which with respect to the implementation of EU competition law have previously been noted by the Court (see, to that effect, judgment of 23 January 2018, F. Hoffmann-La Roche and Others, C‑179/16, EU:C:2018:25, paragraphs 65 and 80), and more particularly the opening of a market, of a medicine containing an active ingredient that has recently entered the public domain, to the manufacturers of generic medicines, the effects of which on prices have been emphasised by the referring court, due account must be taken of the regulatory constraints that are characteristic of the medicine sector. One of those constraints is Article 6 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicines for human use (OJ 2001 L 311, p. 67), as amended by Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 (OJ 2007 L 324, p. 121, and corrigendum OJ 2009 L 87, p. 174), which provides that no medicine may be placed on the market of a Member State unless an MA has been issued by the competent authorities of that Member State or an authorisation has been granted in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicines for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1), as amended by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 (OJ 2009 L 87, p. 109) (judgment of 23 January 2018, F. Hoffmann-La Roche and Others, C‑179/16, EU:C:2018:25, paragraph 53).