Regulation 54 I1

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 F1, 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 F2, 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 F3, GB or NI authorisation to place the product on the market as a medicinal product F4in 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.”.