Blackbay Ventures Ltd v Secretary of State for Health and another [2012] EWHC 2635 (Admin), [2012] All ER (D) 12 (Oct)
The words of Art 80(b) of Council Directive (EC) 2001/83 (on the Community code relating to medicinal products for human use) (the directive) and reg 9 of the Human Use (Manufacturing, Wholesale, Dealing and Miscellaneous Amendments) Regulations 2005 (SI 2005/2789) were clear. They applied to all persons holding a wholesale dealer’s licence (WDL), irrespective of the purported capacity in which they acted. Regulation 9(1)(a) stated that “the holder of a wholesale dealer’s licence” should obtain supplies of relevant medicinal products only from either a manufacturer’s licence holder, or a person who themselves held a WDL for such products. Those words should be given their ordinary meaning. It followed that the claimant’s purchase of medicines from pharmacies without a WDL was in breach of the terms of reg 9 of the regulations.
The conditions applicable to the supply of medicinal products to the public were not harmonised under EU law as it presently stood. Consequently, the regime applicable to persons entrusted with the
