Paragraph 6

In the Health Service Medicines (Control of Prices of Branded Medicines) Regulations 2000^f1 in regulation 2 (interpretation), in paragraph 1—

(a)

after the definition of “branded health service medicine” insert the following definition—

““Directive 2001/83/EC” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use 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, Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, 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 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”;

(b)

in the definition of “marketing authorisation”—

(i)

for sub-paragraph (a), substitute the following—

“(a)

by the competent authority of the United Kingdom in accordance with Directive 2001/83/EC and includes an authorisation granted by the competent authority in accordance with Article 126a of Directive 2001/83; or”, and

(ii)

in sub-paragraph (b), after “Evaluation of Medicinal Products” insert “or Regulation (EC) No. 726/2004 of the European Parliament and 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”.

Annotations

Footnotes

f1: S.I. 2000/123; relevant amending instruments are S.I. 2002/236 and S.I. 2004/3224.