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4.—(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(1), or
(c)the Veterinary Medicines Regulations 2013(2),
or applications for authorisation under such legislation.”.
(3) In paragraph (7)(b), for “the United Kingdom” substitute “Great Britain”.
S.I. 2012/1916, to which there are amendments not relevant to these Regulations.
S.I. 2013/2033, to which there are amendments not relevant to these Regulations.