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  • Title: The future European system for the free circulation of veterinary vaccines in Europe.
    Author: Hankin R.
    Journal: Dev Biol Stand; 1992; 79():3-9. PubMed ID: 1286761.
    Abstract:
    Although Community legislation has only recently been extended to cover veterinary biologicals, these products are fully covered by the recent Commission proposals for the free movement of medicinal products after 1992. The proposals are based on more than 25 years of harmonization of national regulations and more than 10 years' experience of coordinating national decisions on individual medicinal products. The proposals envisage the establishment of two new Community authorization procedures: a centralized procedure based on a single scientific evaluation of the highest possible quality to be undertaken within a new European Medicines Evaluation Agency, leading to a binding EEC-wide decision, with the possibility of limited exceptions to take account of differences in disease status in the Member States; a decentralized procedure based on the concept of mutual recognition of national decisions, with binding Community arbitration in the event of a dispute. To provide the Community institutions with the scientific and technical resources necessary to operate these new procedures, the proposals also provide for the establishment of a European Medicines Evaluation Agency.
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