MEDICINES Title and commencement 1 This Order may be cited as the Medicines (Vaccination against Foot-and-Mouth Disease) Order 2004, and shall come into force on 1st December 2004. Interpretation 2 In this Order— “ the Act ” means the Medicines Act 1968; “the appropriate authority” means in England the Secretary of State for Environment, Food and Rural Affairs, in Wales the National Assembly for Wales, in Scotland the Scottish Ministers and in Northern Ireland the Department of Agriculture and Rural Development; “the Chief Veterinary Officer” means the officer appointed to that post in the Department for Environment, Food and Rural Affairs acting in connection with the Council Directive on FMD ; “the Council Directive on FMD” means Council Directive 2003/85/ EC on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/ EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC ; “establishment of a relevant risk” means the identification by the Chief Veterinary Officer of a relevant risk and communication by her or on her behalf of that identification in such manner and to such persons as she regards appropriate in the circumstances; “FMD” means foot-and-mouth disease; “FMD vaccine” means any veterinary drug presented for use in vaccination against FMD; “lay vaccinator” means a person entitled by virtue of the Veterinary Surgery (Vaccination against Foot-and-Mouth Disease) Order 2004 to carry out a minor treatment under section 19(4)(e) of the Veterinary Surgeons Act 1966 ; “relevant risk” means risk of outbreak of FMD in the United Kingdom which is posed in the circumstances described in Article 50.1(b) of the Council Directive on FMD; “response to a relevant risk” means any act or sequence of acts to prevent an outbreak of FMD in the United Kingdom after the establishment of a relevant risk; “response to an outbreak of FMD” means any act or sequence of acts to control or eradicate FMD in all or any part of the United Kingdom which is undertaken once an outbreak of FMD has occurred in the United Kingdom; “ RNA ” means ribonucleic acid; and other expressions have the same meanings as in the Council Directive on FMD. Supply of FMD vaccine 3 1 The restrictions of sections 52 (“Sale or supply of medicinal products not on general sale list”) and 58(2)(a) (“Medicinal products on prescription only”) of the Act shall not apply to the supply of FMD vaccine by— a a person falling under any of the following categories if he acts within the terms of his engagement by the appropriate authority and does so as part of the appropriate authority’s response to an outbreak of FMD which has occurred in the United Kingdom or as part of the appropriate authority’s response to a relevant risk: i officers of the appropriate authority; ii lay vaccinators; iii other persons engaged by the appropriate authority; or b a person who acts on the instructions of his employer if by virtue of sub-paragraph (a)(iii) the restrictions of sections 52 and 58(2)(a) of the Act do not apply to that employer when he gives those instructions. 2 For the purposes of paragraph (1) an outbreak of FMD has occurred in the United Kingdom where— a the situation described in any of paragraphs 1 to 4 of the Schedule applies in the United Kingdom, and an analysis establishing the finding referred to in that paragraph is confirmed by the Chief Veterinary Officer or on her behalf in such manner and to such persons as she regards appropriate in the situation; or b the situation described in paragraph 5 of the Schedule applies and the Chief Veterinary Officer’s satisfaction described in that paragraph is communicated by her or on her behalf in such manner and to such persons as she regards appropriate in the situation. Ben Bradshaw Parliamentary Under Secretary of State, Department for Environment, Food and Rural Affairs 14th October 2004 Sealed with the Official Seal of the Department of Health, Social Services and Public Safety D.C.Gowdy Permanent Secretary, Department of Health, Social Services and Public Safety 25th October 2004 Sealed with the Official Seal of the Department of Agriculture and Rural Development Pat Toal Permanent Secretary, Department of Agriculture and Rural Development 25th October 2004