# The Patents (Amendment) (EU Exit) Regulations 2019, Regulation 54

Extent: E+W+S+N.I.

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 , GB or NI 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 , GB or NI 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 , 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.”.

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Source: https://www.legislation.gov.uk/uksi/2019/801/regulation/54 (the official version)
Page: https://openlegislation.uk/patents-amendment-eu-exit-regulations-2019/regulation-54
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.