52.—(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(1)”.
(3) After paragraph (e) insert—
“(f)‘comptroller’ means the Comptroller-General of Patents, Designs and Trade Marks;
(g)‘court’ is to be interpreted in accordance with Article 1A;
(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 as a medicinal product 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(2).”.
S.I. 2012/1916. Regulation 58A is inserted by S.I. 2018/xxxx , reg. [ ].