Regulation 52 I1

Article 1 (interpretation) is amended as follows.

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 M1 ”.

After paragraph (e) insert—

“(f)

‘comptroller’ means the Comptroller-General of Patents, Designs and Trade Marks;

F1(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 F2in the United Kingdom as a medicinal product granted F3or 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 M2.”.