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

— 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.

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 () —————

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 Union ◄ , for which the therapeutic indication is the treatment of any of the following diseases:

— acquired immune deficiency syndrome,

— cancer,

— neurodegenerative disorder,

— diabetes,

— auto-immune diseases and other immune dysfunctions,

— viral diseases. 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.

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