ANNEX I

MEDICINAL PRODUCTS TO BE AUTHORISED BY THE ►M8 UNION◄

1. Medicinal products developed by means of one of the following biotechnological processes:
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   recombinant DNA technology,
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   controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells,
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   hybridoma and monoclonal antibody methods.

1. 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 (11)

1. 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 ►M8 Union◄, for which the therapeutic indication is the treatment of any of the following diseases:
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   acquired immune deficiency syndrome,
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   cancer,
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   neurodegenerative disorder,
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   diabetes,
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   auto-immune diseases and other immune dysfunctions,
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   viral diseases.
   ▼M2 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. ▼B

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