The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 No. 775

PART 14 U.K. Amendment of Part 13 (packaging and leaflets)

Insertion of regulations 257C (packaging requirements: advanced therapy medicinal products) and 257D and 257E (guidance and regulations in relation to packing, leaflets and labelling) U.K.

200.  After regulation 257, insert—

“Packaging requirements: advanced therapy medicinal products

257C.— (1) The information specified in Part 4 of Schedule 24 must appear—

(a) on the outer packaging of an advanced therapy medicinal product [F1 for sale or supply in Great Britain only] (other than an exempt advanced therapy medicinal product); and

(b) on the immediate packaging [F2 of that product], unless paragraph (2) or (3) applies to the packaging.

(2) This paragraph applies to the immediate packaging if the packaging is in the form of a blister pack and is placed in outer packaging which complies with the requirements of Part 4 of Schedule 24.

(3) This paragraph applies to immediate packaging if the packaging is too small to display the information required by Part 4 of Schedule 24.

(4) The information specified in Part 5 of Schedule 24 must appear on immediate packaging to which paragraph (2) or (3) applies.

Guidance as to packaging and package leaflets

[F3 257D.— ( 1) The licensing authority may publish guidance on packaging and package leaflets applicable to products for sale or supply in the whole United Kingdom or parts of the United Kingdom, as appropriate.

(2) Guidance published under paragraph (1) may, in particular, include—

(a) the wording of certain special warnings for certain categories of medicinal products;

(b) the particular information needs relating to products that are a pharmacy medicine;

(c) the legibility of particulars on the labelling and package leaflet;

(d) the methods of identification and authentication of medicinal products;

(e) the list of excipients which must feature on the labelling of medicinal products and the way in which these excipients must be indicated.

(3) Until such time as the licensing authority publishes guidance under paragraph (1), any guidance published by the Commission pursuant to Article 65 of the 2001 Directive, insofar as that guidance was in force immediately before IP completion day, continues to apply as if it had been published by the licensing authority under paragraph (1).]

Regulation-making power as to certain forms of labelling

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 Words in reg. 200 inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 154(a)(i)

F2 Words in reg. 200 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 154(a)(ii)

F3 Words in reg. 200 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 154(b)

Commencement Information

I1 Reg. 200 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1