# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 20: Amendment of Schedule 4 (standard provisions of licences under Part 3)


(1) Schedule 4 is amended as follows.
(2) In paragraph 13(b), for “marketing authorisation, Article 126a authorisation” substitute “UK marketing authorisation”.
(3) In the heading of Part 2, for “State Other Than an EEA State” substitute “Country other than an Approved Country for Import”.
(4) In paragraphs 15, 22(1) and 23, for “state other than an EEA State” substitute “country other than an approved country for import”.
(5) In paragraph 25(m), for the words “referred to in Article 8(2) of Directive 2004/23/EC”, substitute—
“assigned by a tissue establishment pursuant to—
(a) paragraph 1 of Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards human gametes and embryos; and
(b) paragraph 1 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other human tissues and cells.”.
(6) In paragraph 33, for “another EEA State” substitute “an approved country for import”.

---
Source: https://www.legislation.gov.uk/ukdsi/2019/9780111179185/regulation/20 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-20
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.