Amendment of regulation 2

16.  Regulation 2(1)(1) (interpretation), at the appropriate places in the alphabetical order insert—

““EAMS medicinal product” means a medicinal product that—

(a)

has been included in the Early Access to Medicines Scheme by means of the licensing authority issuing an EAMS scientific opinion in respect of it; and

(b)

remains in the scheme by virtue of the EAMS scientific opinion not ceasing to have effect in respect of it by virtue of regulation 167D of the 2012 Regulations;”;

““EAMS scientific opinion” is to be construed in accordance with regulation 167C(2)(b) of the 2012 Regulations;”; and

““Early Access to Medicines Scheme” means the scheme of that name established and operated under regulation 167C(1) of the 2012 Regulations;”.