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Paragraph 8 I1I2

United Kingdom

In the Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003f1, 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”,

F1(ii)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iii)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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”.

Annotations

Textual amendments

F1

Regulations revoked (except reg. 12 for specified purposes and Sch. 7 para. 8(a)(i)(b)) (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Commencement

I1

Sch. 7 para. 8(a)(i) in force at 20.11.2005, see reg. 1(b)

I2

Sch. 7 para. 8(a)(ii)(iii)(b) in force at 30.10.2005, see reg. 1(a)

Footnotes

f1

S.I. 2003/1680, regulation 1(2) was amended by S.I. 2004/3224.