Paragraph 4 Amendment of regulation 6 (amendment of Commission Regulation (EC) No 65/2004)

(1)

Regulation 6 is amended as follows.

(2)

In paragraph (2), in the new Article 1 to be substituted by that paragraph—

(a)

in paragraph 1, omit point (d);

(b)

for paragraph 2 substitute—

“2.

This Regulation does not apply to medicinal products for human and veterinary use authorised under—

(a)
Regulation (EC) No 726/2004 of the European Parliament and of the Council,

(b)
the Human Medicines Regulations 2012^f1, or

(c)
the Veterinary Medicines Regulations 2013^f2,

or applications for authorisation under such legislation.”.

(3)

In paragraph (7)(b), for “the United Kingdom” substitute “Great Britain”.

Annotations

Footnotes

f1: S.I. 2012/1916, to which there are amendments not relevant to these Regulations.
f2: S.I. 2013/2033, to which there are amendments not relevant to these Regulations.