# The Human Medicines Regulations 2012, Paragraph 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 imposed pursuant to—
(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.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/6/paragraph/11 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-6/paragraph-11
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.