Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005

Regulation 21

SCHEDULE CONSEQUENTIAL AMENDMENTS OF THE ACT AND OTHER REGULATIONS

1.—(1) Section 7 of the Act (general provisions as to dealing with medicinal products) is amended as follows.

(2) Subsections (2A) and (2B)(1) are repealed.

(3) After subsection 3A(2) insert the following subsection—

“(3B) The restrictions imposed by subsections (2) and (3) of this section shall not apply where the medicinal product concerned is a homoeopathic medicinal product to which the 2001 Directive applies and which fulfils the conditions laid down in Article 14(1) of that Directive.”.

(4) In subsection (7)(3)—

(a) the definition of “certificate of registration” is repealed; and

(b) in the definition of “homoeopathic medicinal product”, the words “products,” and “or compositions” are repealed.

2.  In the Medicines (Labelling) Regulations 1976(4), 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(5),

(ii) the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994, or

(iii) the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005,(6)

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(7).”.

3.  In the Medicines (Leaflets) Regulations 1977(8), for paragraph (2) of regulation 1 (citation, commencement and scope) substitute the following paragraph—

“(2) Nothing in these Regulations applies to a medicinal product for human use to which—

(a) the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994;

(b) the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994; or

(c) the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005,

apply.”.

4.—(1) The Medicines (Advisory Board on the Registration of Homoeopathic Products) Order 1995(9) is amended as follows.

(2) In regulation 1 (citation, commencement and interpretation), in paragraph (2), in the definition of “homoeopathic medicinal product” omit “products,” and “or compositions”.

(3) In regulation 2 (Advisory Board on the Registration of Homoeopathic Products)—

(a) omit paragraph (1)(b);

(b) in paragraph (2)(a), after “human use” insert “as amended by Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components(10), Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use(11), Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use(12) and Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use(13)”; and

(c) in paragraph (2)(d)—

(i) in head (ii) for “8(3)” substitute “8(2)”, and

(ii) in head (iii) for “suspend or revoke” substitute “suspend, vary or revoke”.

(1)

Subsections (2A) and (2B) were inserted by regulation 3(2) of S.I. 1994/276.

(2)

Subsection (3A) was inserted by regulation 54 of S.I. 2004/1031.

(3)

Subsection (7) was substituted by regulation 2(3) of S.I. 1983/1724 and amended by regulation 2(5) of S.I. 1992/604 and regulation 3(4) of S.I. 1994/276.

(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.

(5)

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.

(6)

S.I. 2005/2750.

(7)

S.I. 2004/1031.

(8)

S.I. 1977/1055, regulation 1 was amended by regulation 11 and paragraph 5 of Schedule 7 to S.I. 1994/3144.

(9)

S.I. 1995/309; regulation 2(2)(a) was amended by S.I. 2002/236.

(10)

OJ No. L33, 8.2.2003, p.30.

(11)

OJ No. L159, 27.6.2003, p.46.

(12)

OJ No. L136, 30.4.2004, p.85.

(13)

OJ No. L136, 30.4.2004, p.34.