# The Patents (Amendment) (EU Exit) Regulations 2018, Regulation 54


For Articles 2 (scope) and 3 (conditions for obtaining a certificate), substitute—
“Article 2
Scope
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 authorisation prior to being placed on the market as a medicinal product.
Article 3
Conditions for obtaining a certificate
Where an application is submitted under Article 7, a certificate shall be granted if, at the date of submission of that application—
(a) the product is protected by a basic patent in force;
(b) there is a valid UK authorisation to place the product on the market;
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in point (b) is the first UK authorisation to place the product on the market as a medicinal product.”.

---
Source: https://www.legislation.gov.uk/ukdsi/2018/9780111175347/regulation/54 (the official version)
Page: https://openlegislation.uk/draft-patents-amendment-eu-exit-regulations-2018/regulation-54
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.