Annexes to COM(2002)735 - Modified proposal for a Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision and pharmacovigilance of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (presented by the Commission pursuant to Article 250 (2) of the EC Treaty) - Main contents
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| dossier | COM(2002)735 - Modified proposal for a Regulation of the European Parliament and of the Council laying down Community procedures for the ... |
|---|---|
| document | COM(2002)735  |
| date | March 31, 2004 |
MEDICINAL PRODUCTS TO BE AUTHORISED BY THE COMMUNITY
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.
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 Community, for which the therapeutic indication is the treatment of any of the following diseases:
- acquired immune deficiency syndrome,
- cancer,
- neurodegenerative disorder,
- diabetes,
and with effect from 20 May 2008
- auto-immune diseases and other immune dysfunctions,
- viral diseases.
After 20 May 2008, the Commission, having consulted the Agency, may present any appropriate proposal modifying this point and the Council shall take a decision on that proposal by qualified majority.
4. Medicinal products that are designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000.