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7. In regulation 15 (exempt activities)—
(a)the existing text becomes paragraph (1),
(b)in sub-paragraph (e), for the words from “Regulation (EC) No. 726/2004” to “Agency”, substitute “Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency(1)”,
(c)at the end of sub-paragraph (e), after “marketed;” insert “and”,
(d)omit—
(i)sub-paragraph (f), and
(ii)the word “and” immediately following that sub-paragraph, and
(e)after paragraph (1) insert—
“(2) In paragraph (1)(e), “Regulation 2309/93” means Council Regulation (EEC) No 2309/93 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(2), as it had effect before it was repealed by Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency(3)”.
OJ L 136, 30.4.2004, p.1, as last amended by Regulation (EU) No 1027/2012 of the European Parliament and of the Council (OJ L 316, 14.11.2012, p.38).
OJ L 214, 24.8.1993, p.1, as amended by Commission Regulation (EC) No 649/98 (OJ L 88, 24.3.1998, p.7), Council Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p.36), and Commission Regulation (EC) No 1647/2003 (OJ L 245, 29.9.2003, p.19).
OJ L 136, 30.4.2004, p.1.
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