A product may, under the terms and conditions provided for in this Regulation, be the subject of a certificate if it is—
(a)protected by a patent; and
(b)the subject of a UK , GB or NI authorisation prior to being placed on the market as a medicinal product.]
Textual Amendments
F1Art. 2 substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 54 (as amended by S.I. 2020/1471, regs. 1(2), 3(4)); 2020 c. 1, Sch. 5 para. 1(1)