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Authorization of Medicinal Products

Regulation (EC) No.726-2004 for Authorisation and supervision of medicinal products

With this Regulation, the European Union (EU) develops and improves the Community procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human and veterinary use. The Regulation also provides the legal basis for the European Medicines Agency, which was established in 1993.

Scope
No medicinal product appearing in the Annex may be placed on the Community market without prior authorization from the Community.

The centralized authorization procedure will be compulsory for:

  • Medicinal products derived from biotechnology;
  • Advanced therapy medicinal products;
  • Orphan medicinal products;
  • Medicinal products containing an entirely new active substance for which the therapeutic indication is the treatment of acquired immune deficiency syndrome, cancer, neurodegenerative disorder or diabetes, auto-immune diseases and other immune dysfunctions and viral diseases.

The centralised authorisation procedure will be optional for:

  • Other medicinal products containing a new active substance;
  • Medicinal products which constitute a therapeutic, scientific or technical innovation or are of interest at Community level.

Immunological veterinary medicinal products for the treatment of animal diseases that are subject to Community prophylactic measures may also be granted such authorisation. Finally, generic medical products of reference medicinal products authorised by the Community may be subject to a decentralised authorisation procedure, provided that the harmonization achieved at Community level is maintained.

Authorization of medicinal products for human/ veterinary use
The Committee for Medicinal Products for human / veterinary use is part of the European Medicines Agency. It is responsible for drawing up the opinion of the Agency on any matter concerning the evaluation of medicinal products for human / veterinary use.

Each application for authorization must be accompanied by the particulars and documents referred to in Directive 2001/83/EC on the Community code relating to medicinal products for human use and Directive 2001/82/EC for veterinary use, and by the fee payable to the Agency. It should also contain a statement to the effect that clinical trials carried out outside the European Union meet the principles of good clinical practice and the ethical requirements of Directive 2001/20/EC on good clinical practice in the conduct of clinical trials on medicinal products for human use.

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