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

Amendment of regulation 1 of the Homoeopathic Regulations

2.—(1) Regulation 1 of the Homoeopathic Regulations (citation, commencement and interpretation) is amended as follows.

(2) In paragraph (2)—

(a) after the definition of “certificate of registration” insert the following definition—

““concerned member State” means an EEA state, the competent authority of which receives an application to obtain recognition, according to the procedure laid down in Articles 28 and 29(1) to (3) of the 2001 Directive, of an EC registration;”;

(b) in the definition of “the 2001 Directive”(1) after “as amended” insert—

• “by—

  (a)

  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(2),

  (b)

  Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use(3),

  (c)

  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(4), and

  (d)

  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(5);”;

(c) after the definition of “the 2001 Directive” insert the following definitions—

““EEA State” means a Member State, Norway, Iceland or Liechtenstein;

“EC registration” means a registration granted by a competent authority of an EEA State in accordance with the procedure set out in Article 14 of the 2001 Directive;”;

(d) in the definition of “homoeopathic medicinal product” omit “products,” and “or compositions”; and

(e) after the definition of “homoeopathic medicinal product” insert the following definition—

““set of applications” means—

(a)

a number of applications to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Articles 28 and 29(1) to (3) of the 2001 Directive of a single certificate of registration in other EEA States, where those applications to the licensing authority all relate to applications for EC certificates of registration in other EEA States that have the same 90 day assessment period for the purposes of Article 28(4) of the 2001 Directive; or

(b)

a number of applications to competent authorities of other EEA States for EC certificates of registration relating to a single certificate of registration, where those applications all have the same 90 day assessment period for the purposes of Article 28(4) of the 2001 Directive.”.

(3) In paragraph (3), for sub-paragraph (c) substitute the following sub-paragraph—

“(c) any expressions which are also used in the 2001 Directive shall have the same meaning as they have in the 2001 Directive and related expressions shall be construed accordingly.”.

(1)

The definition of “the 2001 Directive” was inserted by regulation 9(a) of S.I. 2002/236 and amended by regulation 5 of S.I. 2003/2321.

(2)

OJ No. L33, 8.2.2003, p.30.

(3)

OJ No. L159, 27.6.2003, p.46.

(4)

OJ No. L136, 30.4.2004, p.85.

(5)

OJ No. L136, 30.4.2004, p.34.