The Medicines (Advertising Amendments) Regulations 2005

Amendment of regulation 2 of the principal Regulations

2.  In regulation 2 of the principal Regulations (interpretation)—

(a) in the appropriate alphabetical place, insert the following definitions—

““certificate of registration” means a certificate of registration granted by the licensing authority under the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(1);

“homoeopathic medicinal product” means a medicinal product (which may contain a number of principles) prepared from substances called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, any pharmacopoeia used officially in a Member State; and

“traditional herbal registration” means a registration granted by the licensing authority under the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005(2);”;

(b) in the definition of “the 2001 Directive”, 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(3),

  (b)

  Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use(4),

  (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(5), 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(6)”;

(c) for the definition of “marketing authorization” substitute—

““marketing authorization” means—

(a)

a marketing authorization granted by the licensing authority under the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(7),

(b)

a marketing authorization granted by the European Commission under Council Regulation (EEC) 2309/93(8) 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(9),

(c)

an authorization granted by the licensing authority in accordance with Article 126a of the 2001 Directive, or

(d)

a product licence granted by the licensing authority under Part II of the Act;”;

(d) in the definition of “relevant medicinal product”—

(i) for paragraph (a) substitute—

“(a) a medicinal product for human use to which the 2001 Directive applies and accordingly includes products to which Title II of Regulation (EC) No. 726/2004 applies, or”,

(ii) in paragraph (b), in sub-paragraph (ii), omit “or”, and

(iii) omit paragraph (c); and

(e) in the definition of “summary of product characteristics”, for “product licence” substitute “marketing authorization or traditional herbal registration”.

(1)

S.I. 1994/105; as amended by S.I. 1994/899, 1995/541, 1996/482, 1998/574, 1999/566, 2001/795, 2002/236 and 542, 2003/625 and 2321, and 2004/666.

(2)

S.I. 2005/2750.

(3)

OJ No. L33, 8.2.2003, p.30.

(4)

OJ No. L159, 27.6.2003, p.46.

(5)

OJ No. L136, 30.4.2004, p.85.

(6)

OJ No. L136, 30.4.2004, p.34.

(7)

S.I. 1994/3144; relevant amending instruments S.I. 1998/3105, 2000/292, 2001/795, 2002/236, 2002/542, 2003/2321, 2004/3224 and 2005/2759.

(8)

OJ No. L214, 24.8.1993, p.1.

(9)

OJ No. L136, 30.4.2004, p.1.