- Latest available (Revised)
- Original (As made)
This is the original version (as it was originally made). This item of legislation is currently only available in its original format.
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”.
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
Click 'View More' or select 'More Resources' tab for additional information including: