Abstract
The composite Protocol text includes provisions in Article 4 Declarations for the Declaration of Various Production Facilities. These include the declaration of each facility… with primary production containment or high biological containment produced with the use of fermenters and/or bioreactors, embryonated eggs or other means … microorganisms or substances causing a specific and protective immune response as an ingredient of
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(a)
Any vaccine for humans that is for the general public or the armed forces, or was licensed, registered or otherwise approved by a component of the government of the State party for distribution or sale;
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(b)
Any vaccine for animals that is available to the general public, or which was licensed, registered or otherwise approved by a component of the government of the State party for distribution or sale; [Emphasis added]
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Notes
Pan-European Regulatory Forum on Pharmaceuticals. Information available at http://perf. eudra.org
Council Directive, On the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, 65/65/EEC, 26 January 1965, Official Journal of the European Communities, 369/65, 9 February 1965, 20–24.
Council Directive, On the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products, 75/318/EEC, 20 May 1975, Official Journal of the European Communities, No L 147/1, 9 June 1975, 1–12.
Council Directive, On the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, 75/319/EEC, 20 May 1975, Official Journal of the European Communities, No L 147/13, 9 June 1965, 13-22.
Council Directive, On the approximation of the laws of the Member States relating to veterinary medicinal products, 81/851/EEC, 28 September 1981, Official Journal of the European Communities, No L 317/1, 6 November 1981, 1–15.
European Community, Guide to Good Manufacturing Practice for medicinal products, reproduced in Medicines Control Agency, Rules and Guidance for Pharmaceutical Manufacturers and Distributors 1997, The Stationery Office. London, 1997.
Council Directive, Laying down the principles and guidelines of good manufacturing practice for medicinal products for human use, 91/356/EEC, 13 June 1991, Official Journal of the European Communities, No L 193/20, 17 July 1991, 30–33. Available at http://europa.eu.int/eur-lex/en/lif/dat/1991/en_391L0356.html
Council Directive, Laying down the principles and guidelines of good manufacturing practice for medicinal products for veterinary medical products, 91/412/EEC, 23 July 1991, Official Journal of the European Communities, No L 228/70, 23 July 1991, 70–73. Available at http://pharmacos.eudra.org/F2/homeplus.html
European Community, Guide to Good Manufacturing Practice for Medicinal Products, First edition, 1989. Second edition, 1991 (with 12 additional annexes included). Third edition, 1998 (with 14 additional annexes included).
See, for example, Graham S. Pearson, Article X: Pharmaceutical Building Blocks, University of Bradford, Department of Peace Studies, Briefing Paper No 8, July 1998. Available at http://www.brad.ac.uk/acad/sbtwc
For information on Mutual Recognition Agreements (MRAs) see http://pharmacos.eudra.org/F2/homeplus.html
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Negut, M. (2002). Good Manufacturing Practice and Licensed Products. In: Dando, M.R., Klement, C., Negut, M., Pearson, G.S. (eds) Maximizing the Security and Development Benefits from the Biological and Toxin Weapons Convention. NATO Science Series, vol 36. Springer, Dordrecht. https://doi.org/10.1007/978-94-010-0472-5_25
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