The Human Medicines Regulations 2012 No. 1916

SCHEDULES

SCHEDULE 34 U.K. Amendments to existing law

PART 5 U.K. Other United Kingdom, Scotland and Wales Secondary legislation

Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003 U.K.

82.—(1) The Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003 M1 (interpretation) are amended as follows. U.K.

(2) In regulation 1(2)—

(a) omit the following definitions—

(i) “the 1994 Regulations”, and

(ii) “herbal remedy”;

(b) before the definition of “the appropriate committee” insert—

““the 2012 Regulations” means the Human Medicines Regulations 2012;”.

(c) for the definition of “the appropriate committee” substitute—

““the appropriate committee” means whichever the appropriate Minister considers to be the appropriate body of the following—

(a)

the Commission; or

(b)

an expert committee appointed by the appropriate Minister, or by the appropriate Ministers for Great Britain and for Northern Ireland acting jointly;”;

(d) after the definition of “the appropriate Minister” insert—

““the Commission” means the Commission on Human Medicines continued in existence by regulation 9 of the 2012 Regulations;”;

(e) for the definition of “excluded medicine” substitute—

““excluded medicine” means a medicinal product to which the restrictions in regulation 46 (requirement for authorisation) of the 2012 Regulations do not apply by virtue of regulation 3(6) (scope of these Regulations: special provisions) or 4(1) (special provisions for pharmacies etc) of those Regulations;”;

(f) in the definition of “market” for the words from “have the same meaning” to the end substitute “ are to be construed in accordance with the 2012 Regulations; ”;

(g) for the definition of “medicinal product” substitute—

““medicinal product” has the meaning given by regulation 2 of the 2012 Regulations;”; and

(h) in the definition of “unlicensed product”—

(i) in paragraph (a)(i), for “the 1994 Regulations” substitute “ the 2012 Regulations ”,

(ii) omit paragraph (b) and the word “or” following it,

(iii) for paragraph (c) substitute—

“(c) no traditional herbal registration has been granted by the licensing authority under the 2012 Regulations;”, and

(iv) after that paragraph insert the word “ or ” and the following paragraph —

“(d) no Article 126a authorisation has been granted by the licensing authority under those regulations;”.

Marginal Citations

M1 S.I. 2003/1680, as amended by S.I. 2004/3224, S.I. 2005/2750 and S.I. 2005/2754.