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Serum Industry

Resources

Critical Regulations

USDA – United States Department of Agriculture

FDA – Food and Drug Administration - USA

DEFRA – Department for Environment, Food and Rural Affairs - UK

EC – European Commission

  • TSE Roadmap
  • EC 999/2001 - laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies
      • Revision 688/2006 - monitoring of transmissible spongiform encephalopathies and specified risk material of bovine animals in Sweden
      • Revision 1041/2006 – monitoring of transmissible spongiform encephalopathies in ovine animals
      • Revision 1923/2006 – laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies
  • EC 2909 - 2004
  • EC 1774 – 2002 EU By-products Regulation
      • Revision 808/2003 - laying down health rules concerning animal by-products not intended for human consumption
      • Revision 668/2004 - regards the importation from third countries of animal by-products
      • Revision 416/2005 - regards the importation from Japan of certain animal by-products intended for technical purposes
      • Revision 1192/2006 - regards lists of approved plants in Member States
      • Revision 2007/2006 - importation and transit of certain intermediate products derived from Category 3 material intended for technical uses in medical devices, in vitro diagnostics and laboratory reagents
      • Revision 185/2007
      • Revision 2909/2004 Revision v12 - regards the importation and transit of certain intermediate products derived from Category 3 material intended for technical uses in medical devices, in vitro diagnostics and laboratory reagent
  • C 96/22 - prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists
  • EC 96/23 - measures to monitor certain substances and residues thereof in live animals and animal products
  • EC523/2008 -amending Annexes VIII, X and XI to Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the import of blood products for the manufacture of technical products

SANCO – Directorate of general health and Consumer Affairs - EU

    • Report on Animal By-Products
    • SANCO 10452 v5 - laying down health rules as regards animal by-products not intended for human consumption and repealing Regulation (EC) No 1774/2002
    • SANCO 10487 v6 – laying down of transitional measures certain animal by-products classified as Category 1 and 2 materials and intended for technical purposes
    • SANCO 10100 v8 – laying down of transitional measures certain animal by-products classified as Category 1 and 2 materials and intended for technical purposes
    • SANCO 10777/2006 v3 – laying down rules for certain intermediate products intended for technical uses.
    • SANCO 10781/2006 v2 – guidance on importation of certain intermediate animal by-products used in diagnostic medical devices and laboratory reagents
    • SANCO 10571/2006 – regards the marking and transport of animal by-products

AQIS – Australian Quarantine and Inspection Service

OIE - World Organisation for Animal Health

EMEA - European Agency for the Evaluation of Medicinal Products