{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2006/schedule-1/paragraph-3",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2006/schedule-1/paragraph-3.json",
  "legislation": "uksi/2006/2407",
  "legislation_title": "The Veterinary Medicines Regulations 2006",
  "legislation_url": "https://openlegislation.uk/veterinary-medicines-regulations-2006",
  "path": "schedule/1/paragraph/3",
  "kind": "paragraph",
  "number": "3",
  "heading": "Summary of product characteristics",
  "text": "The summary of product characteristics required under the preceding paragraph shall include the following information, set out in the same format—\nSummary of product characteristics\n1\nName of the veterinary medicinal product, including its strength and pharmaceutical form.\n2\nThe name and proportion of each active substance, and of any excipient if knowledge of the excipient is needed for safety reasons.\n3\nPharmaceutical form.\n4\nClinical particulars—\n4.1\ntarget species;\n4.2\nindications for use, specifying the target species;\n4.3\ncontra-indications;\n4.4\nspecial warnings for each target species;\n4.5\nspecial precautions for use, including special precautions to be taken by the person administering the medicinal product to the animals;\n4.6\nadverse reactions (frequency and seriousness);\n4.7\nuse during pregnancy, lactation or lay;\n4.8\ninteraction with other medicinal products and other forms of interaction;\n4.9\namounts to be administered and administration route;\n4.10\noverdose (symptoms, emergency procedures, antidotes) if necessary;\n4.11\nwithdrawal periods for the various foodstuffs, including those for which the withdrawal period is zero.\n5\nPharmacological properties—\n5.1\npharmacodynamic properties;\n5.2\npharmacokinetic particulars.\n6\nPharmaceutical particulars—\n6.1\nlist of excipients;\n6.2\nmajor incompatibilities;\n6.3\nshelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time;\n6.4\nspecial precautions for storage;\n6.5\nnature and contents of immediate packaging;\n6.6\nspecial precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate.\n7\nMarketing authorisation holder.\n8\nMarketing authorisation number.\n9\nDate of the first authorisation or date of renewal of the authorisation.\n10\nDate of any revision of the text.\n11\nAny other information required by the Secretary of State.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "I",
      "label": "I1",
      "text": "Sch. 1 para. 3 in force at 1.10.2006, see reg. 1"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2006/2407/schedule/1/paragraph/3",
    "retrieved_at": "2026-10-29T04:22:09.984208+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}