The Human Medicines Regulations 2012

Regulations 36(3) and 42(3)

SCHEDULE 6 U.K. Manufacturer's and wholesale dealer's licences for exempt advanced therapy medicinal products

PART 1 U.K. Manufacturer's licences

1.  The requirements in paragraphs 2 to 12 apply to a manufacturer's licence insofar as it relates to the manufacture and assembly of exempt advanced therapy medicinal products. U.K.

2.  The licence holder must inform the licensing authority of any adverse reaction or suspected adverse reaction of which the holder is aware within the period of 15 days beginning on the day following the first day on which the holder knew about the reaction. U.K.

3.  The licence holder must ensure, if using human cells or tissues in an exempt advanced therapy medicinal product, that the donation, procurement and testing of those cells or tissues is in accordance with [F1 requirements imposed pursuant to— U.K.

(a) paragraphs 6 to 9 of Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards gametes and embryos; and

(b) paragraphs 9 to 12 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other tissues and cells.]

Textual Amendments

F1 Sch. 6 para. 3(a)(b) and words substituted for words (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 26(2); 2020 c. 1, Sch. 5 para. 1(1)

4.  The licence holder must ensure that any human tissue or cell component imported into the United Kingdom and used by the holder as a starting material or raw material in the manufacture of an exempt advanced therapy medicinal product shall meet equivalent standards of quality and safety to those [F2 imposed pursuant to— U.K.

(a) Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards gametes and embryos; and

(b) Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other tissues and cells.]

Textual Amendments

F2 Sch. 6 para. 4(a)(b) and words substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 26(3); 2020 c. 1, Sch. 5 para. 1(1)

5.  The licence holder must ensure that any blood or blood component imported into the United Kingdom and used by the manufacturer's licence holder as a starting material or raw material in the manufacture of an exempt advanced therapy medicinal product meets equivalent standards of quality and safety to those laid down in [F3 the Blood Quality and Safety Regulations 2005]. U.K.

Textual Amendments

F3 Words in Sch. 6 para. 5 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 26(4); 2020 c. 1, Sch. 5 para. 1(1)

6.  Where the holder of a manufacturer's licence distributes by way of wholesale dealing any exempt advanced therapy medicinal product manufactured or assembled pursuant to the licence that person must comply with— U.K.

(a) the requirements of paragraphs 15, 16, 18 and 19; and

(b) the guidelines on good distribution practice published by the European Commission in accordance with Article 84 of the 2001 Directive;

as if that person were the holder of a wholesale dealer's licence.

7.  The licence holder must, at the written request of the licensing authority, set up a risk management system designed to identify, characterise, prevent or minimise risks related to the exempt advanced therapy medicinal product. U.K.

8.  The licence holder must establish and maintain a system ensuring that the exempt advanced therapy medicinal product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the establishment where the product is used. U.K.

9.  The licence holder must, subject to paragraph 27 of Schedule 4, keep the data referred to in paragraph 8 for a minimum of 30 years after the expiry date of the exempt advanced therapy medicinal product. U.K.

10.  The licence holder must secure that the data referred to in paragraph 8 will, in the event that— U.K.

(a) the licence is suspended, revoked or withdrawn; or

(b) the licence holder becomes bankrupt or insolvent,

be held available to the licensing authority by the holder of a manufacturer's licence for the period described in paragraph 9 or such longer period as may be required pursuant to paragraph 27 of Schedule 4.

11.  The licence holder must, where an exempt advanced therapy medicinal product contains human cells or tissues, ensure that the traceability system established in accordance with paragraph 8 is complementary to and compatible with the requirements [F4 imposed pursuant to— U.K.

(a) as regards gametes and embryos, sections 12(3), and 33A to 33D of, and paragraph 1 of Schedule 3A to, the Human Fertilisation and Embryology Act 1990;

(b) as regards blood cells, regulations 8, 9(e) and 14 of the Blood Safety and Quality Regulations 2005; and

(c) as regards other cells and tissues, regulations 13 and 16 of, and paragraph 1 of Schedule 2 to, the Human Tissue (Quality and Safety for Human Application) Regulations 2007].

Textual Amendments

F4 Sch. 6 paras. 11(a)-(c) and words substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 26(5); 2020 c. 1, Sch. 5 para. 1(1)

12.  The licence holder must not import or export any exempt advanced therapy medicinal product. U.K.

PART 2 U.K. Wholesale dealer's licences

13.  The requirements in paragraphs 14 to 20 apply to a wholesale dealer's licence insofar as it relates to exempt advanced therapy medicinal products. U.K.

14.  The licence holder must obtain supplies of exempt advanced therapy medicinal products only from— U.K.

(a) the holder of a manufacturer's licence in respect of those products; or

(b) the holder of a wholesale dealer's licence in respect of those products.

15.  The licence holder must distribute an exempt advanced therapy medicinal product by way of wholesale dealing only to— U.K.

(a) the holder of a wholesale dealer's licence in respect of those products; or

(b) a person who—

(i) may lawfully administer those products, and

(ii) solicited the product for an individual patient.

16.  The licence holder must establish and maintain a system ensuring that the exempt advanced therapy medicinal product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the establishment where the product is used. U.K.

17.  The licence holder must inform the licensing authority of any adverse reaction to any exempt advanced therapy medicinal product supplied by the holder of the wholesale dealer's licence of which the holder is aware. U.K.

18.  The licence holder must, subject to paragraph 44 of Schedule 4, keep the data referred to in paragraph 16 for a minimum of 30 years after the expiry date of the exempt advanced therapy medicinal product. U.K.

19.  The licence holder must secure that the data referred to in paragraph 16 will, in the event that— U.K.

(a) the licence is suspended, revoked or withdrawn; or

(b) the licence holder becomes bankrupt or insolvent,

be held available to the licensing authority by the holder of a wholesale dealer's licence for the period described in paragraph 18 or such longer period as may be required pursuant to paragraph 44 of Schedule 4.

20.  The licence holder must not import or export any exempt advanced therapy medicinal product. U.K.