ANNEX U.K.MEDICINAL PRODUCTS TO BE AUTHORISED BY THE COMMUNITY

1. Medicinal products developed by means of one of the following biotechnological processes: U.K.

• recombinant DNA technology,

• controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells,

• hybridoma and monoclonal antibody methods.

[F1 1a. Advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products] (1) U.K.

Textual Amendments

F1 Inserted by Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance).

2. Medicinal products for veterinary use intended primarily for use as performance enhancers in order to promote the growth of treated animals or to increase yields from treated animals. U.K.

3. Medicinal products for human use containing a new active substance which, on the date of entry into force of this Regulation, was not authorised in the Community, for which the therapeutic indication is the treatment of any of the following diseases: U.K.

• acquired immune deficiency syndrome,

• cancer,

• neurodegenerative disorder,

• diabetes,

• auto-immune diseases and other immune dysfunctions,

• viral diseases.

[F2 After 20 May 2008 , the Commission, having consulted the Agency, may present any appropriate proposal to amend this point and the European Parliament and the Council shall take a decision thereon in accordance with the Treaty.]

Textual Amendments

F2 Substituted by Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance).

4. Medicinal products that are designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000. U.K.

(1)

[F1 OJ L 324, 10.12.2007, p. 121 .]

Textual Amendments

F1 Inserted by Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance).