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2. In the Medicines (Labelling) Regulations 1976(1), for paragraph (2) of regulation 1 (citation and scope) substitute the following paragraph—
“(2) Nothing in these Regulations applies to—
(a)a medicinal product for human use to which—
(i)the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(2),
(ii)the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994, or
(iii)the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005,(3)
apply; or
(b)a medicinal product which is an investigational medicinal product within the meaning of the Medicines for Human Use (Clinical Trials) Regulations 2004(4).”.
S.I. 1976/1726, regulation 1 was amended by regulation 11 and paragraph 3 of Schedule 7 to S.I. 1994/3144, and by regulation 54 and paragraph 6 of Part 2 of Schedule 10 to S.I. 2004/1031.
S.I. 1994/3144, as amended by S.I. 1998/3105, 2000/292, 2001/795, 2002/236 and 542, 2003/2321, 2004/3224, 2005/50 and 1710.
S.I. 2005/2750.
S.I. 2004/1031.
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