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8. In the Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003(1), in regulation 1 (citation, commencement and interpretation), in paragraph (2)—
(a)in the definition of “unlicensed product”—
(i)in sub-paragraph (a)(ii) after “Medicinal Products” insert “or under 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”,
(ii)at the end of sub-paragraph (b) insert “or”, and
(iii)after sub-paragraph (b) insert the following sub-paragraph—
“(c)no traditional herbal registration has been granted by the licensing authority under the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005;”; and
(b)in the definition of “the TSE Guideline” after “for human use” insert “as substituted by Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use”.
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