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European Medicines Agency (EMA)
ANNEX I

ANNEX I

▼B

MEDICINAL PRODUCTS TO BE AUTHORISED BY THE ►M8 UNION

  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.
▼M2
  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)
▼M8 ————— ▼B
  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:
    acquired immune deficiency syndrome,
    cancer,
    neurodegenerative disorder,
    diabetes,
    auto-immune diseases and other immune dysfunctions,
    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.
▼M8