Sch 2 para 3
Any activity carried on in respect of an active substance by a person who— (a) is registered in accordance with regulation 45N of the Human Medicines Regulations 2012, or (b) is exempt from any requirement to be so registered by virtue of regulation 45M(2) or (3) of those Regulations. In this paragraph “ active substance ” has the same meaning as in the Human Medicines Regulations 2012 (see regulation 8 of those Regulations).