F1ANNEX IMEDICINAL PRODUCTS TO BE AUTHORISED BY THE F1UNION
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.
F31a.
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 products27
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.
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 F1Union, 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.
F2After 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.
Substituted by Regulation (EU) 2019/5 of the European Parliament and of the Council of 11 December 2018 amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Regulation (EC) No 1901/2006 on medicinal products for paediatric use and Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance).