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
