Where an application is submitted under Article 7, a certificate shall be granted if, at the date of submission of that application—
the product is protected by a basic patent in force;
there is a valid UK, GB or NI authorisation to place the product on the market;
the product has not already been the subject of a certificate;
the authorisation referred to in point (b) is the first UK, GB or NI authorisation to place the product on the market as a medicinal product in the territory of the United Kingdom, the territory of England and Wales and Scotland or the territory of Northern Ireland as the case may be.]
Textual Amendments
F1Art. 3 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(5)); 2020 c. 1, Sch. 5 para. 1(1)