# The Patents (Amendment) (EU Exit) Regulations 2019, Regulation 52

Extent: E+W+S+N.I.

(1) Article 1 (interpretation) is amended as follows.
(2) In paragraph (e) for “Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use”, substitute “ regulation 58A(3) of the Human Medicines Regulations 2012 ”.
(3) After paragraph (e) insert—
“(f) ‘comptroller’ means the Comptroller-General of Patents, Designs and Trade Marks;
(g) ‘court’ means—
(i) as respects England and Wales, the High Court;
(ii) as respects Scotland, the Court of Session;
(iii) as respects Northern Ireland, the High Court in Northern Ireland;
(h) “EEA authorisation” means an authorisation to place a medicinal product on the market which has effect in an EEA state in accordance with Directive 2001/83/EC or Directive 2001/82/EC;
(i) ‘patent’ means a patent which has effect in the United Kingdom;
(j) ‘UK authorisation’ means, in relation to a product, an authorisation to place that product on the market in the United Kingdom as a medicinal product granted or having effect as if granted in accordance with—
(i) Part 5 of the Human Medicines Regulations 2012; or
(ii) regulation 4(3) of, and Schedule 1 to, the Veterinary Medicines Regulations 2013 .”.

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Source: https://www.legislation.gov.uk/uksi/2019/801/regulation/52 (the official version)
Page: https://openlegislation.uk/patents-amendment-eu-exit-regulations-2019/regulation-52
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.