54. For Articles 2 (scope) and 3 (conditions for obtaining a certificate), substitute—
“Article 2Scope
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 3Conditions 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.”.