PART 13 U.K.Packaging and leaflets

CHAPTER 1 U.K.

Requirements for packaging and package leaflets relating to medicinal products U.K.

[F1 Regulation-making power as to certain forms of labelling U.K.

257E.   The Ministers may by regulations require the use of certain forms of labelling of a medicinal product in order to make it possible to ascertain—

(a) the price of the medicinal product;

(b) any reimbursement conditions of the National Health Service;

(c) the legal status for supply to the patient in accordance with regulation 5 (classification), insofar as not already provided for in Schedule 25;

(d) authenticity and identification of the medicinal product in accordance with Article 54a(5) of the 2001 Directive.]

Textual Amendments

F1 Regs. 257C-257E inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 200 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 154); 2020 c. 1, Sch. 5 para. 1(1)