MEDICINAL PRODUCTS TO BE AUTHORISED BY THE ►M8 UNION◄
- 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.
- 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)
- 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: —acquired immune deficiency syndrome,—cancer,—neurodegenerative disorder,—diabetes,—auto-immune diseases and other immune dysfunctions,—viral diseases.
- Medicinal products that are designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000.