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References

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    (2004) Regulation (EC) No 726/2004 of the European Parliament and of The Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Official Journal of the European Union.
  • 2
    (2001) Directive 2001/82/EC of the European Parliament and of The Council of 6 November 2001 on the Community code relating to veterinary medicinal products. Official Journal of the European Communities.
  • 3
    (2013) European Pharmacopoeia, 7th edn., European Directorate for the Quality of Medicines & HealthCare (EDQM), Strasbourg.
  • 4
    Legrand, L., Pitel, P.-H., Marcillaud-Pitel, C., Cullinane, A., Couroucé-Malblanc, A., Fortier, G., Freymuth, F. and Pronost, S. (2013) Surveillance of equine influenza viruses through the RESPE network in France from November 2005 to October 2010. Equine Vet. J. 45, 776783.
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    (2008) Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products. Official Journal of the European Union.
  • 6
    (2009) Directive 2009/53/EC of the European Parliament and of The Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products. Official Journal of the European Communities.
  • 7
    (2013) Guideline on the Compliance of Authorised Equine Influenza Vaccines with OIE Requirements, EMA/CVMP/IWP/97961/2013-CONSULTATION.Draft. European Medicines Agency, London. http://www.emea.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500142475.
  • 8
    (1998) Note for Guidance: Harmonisation of Requirements for Equine Influenza Vaccines – Specific Requirements for Substitution or Addition of a Strain or Strains, EMEA/CVMP/112/98-FINAL. European Medicines Agency, London. http://www.emea.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500004632.