If a product is referred to the Veterinary Products Committee (VPC) for advice, the VPC will be provided with a briefing document. Relevant scientific assessors will attend the VPC meeting and respond to questions by VPC members as directed by the VPC Chair.<\/p>
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Legislation and published guidance set out the information (including data, scientific studies and risk assessments) that applicants must provide for a new marketing authorisation or change to an existing marketing authorisation. Each part of the dossier is supplemented by a critical overall summary prepared by an appropriate scientific expert commissioned by the applicant. The VMD assess the data package against the same guidance. Every year a sample of VMD assessment reports is reviewed by the VPC to score the VMD\u2019s assessment of the application against criteria in the areas of: quality, efficacy and target species safety, safety to the user and consumers, environmental safety and overall benefit risk.<\/p>
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If a non-prescription category is already established, another product will normally be allowed to have the same distribution category provided it contains the same active substance, is the same pharmaceutical presentation, and for the same species. Should information become available at any stage post-authorisation that potentially impacts the benefit-risk balance, the VMD can review the marketing authorisation(s) and require changes and/or suspend a product (or group of products) to protect animal health, public health and the environment.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/1547", "label" : {"_value" : "Biography information for Lord Benyon"} } , "answeringMemberPrinted" : {"_value" : "Lord Benyon"} , "dateOfAnswer" : {"_value" : "2023-07-24", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2023-07-24T15:33:07.27Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "13"} , "answeringDeptShortName" : {"_value" : "Environment, Food and Rural Affairs"} , "answeringDeptSortName" : {"_value" : "Environment, Food and Rural Affairs"} , "date" : {"_value" : "2023-07-19", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Veterinary Medicine"} , "houseId" : {"_value" : "2"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25277", "prefLabel" : {"_value" : "House of Lords"} } ], "questionText" : "To ask His Majesty's Government, further to the Written Answer by Lord Benyon on 13 July (HL9237), what is the process for members of the Veterinary Products Committee to question the Veterinary Medicines Directorate\u2019s assessors following receipt of the assessment report; what criteria the Veterinary Medicines Directorate uses to determine whether any potential increased risks to (1) animal health, (2) public health, or (3) the environment, can be suitability mitigated; and what criteria the Veterinary Medicines Directorate uses to assess the potential benefits of allowing over-the-counter sale, especially when the non-prescription category is already established.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4171", "label" : {"_value" : "Biography information for Lord Black of Brentwood"} } , "tablingMemberPrinted" : [{"_value" : "Lord Black of Brentwood"} ], "uin" : "HL9487"} , {"_about" : "http://data.parliament.uk/resources/1654543", "AnsweringBody" : [{"_value" : "Department for Environment, Food and Rural Affairs"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1654543/answer", "answerText" : {"_value" : "
The scientific review committee for pharmaceutical products is chaired by the Head of Pharmaceuticals. Membership includes all pharmaceutical assessors (quality, safety and efficacy), representatives from Regulatory Affairs, Pharmacovigilance, and other government bodies including the UK Health Security Agency, Health and Safety Executive, Food Standards Agency, Environment Agency, and the Department of Agriculture, Environment and Rural Affairs of Northern Ireland. Other agencies may also be invited on an ad hoc basis.<\/p>
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The documents for the formal review meeting include the assessment report, list of questions to be addressed by the applicant and an executive summary which highlights the main issues and the benefit-risk conclusion.<\/p>
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The scientific review committee provides a formal peer -review forum, where each application is summarised, and key issues raised and discussed. The operation of the committee is described in internal operating procedures. Formal minutes are produced. The committee output is to endorse the list of questions for the applicant, decide whether these are likely to be resolvable, agree the benefit-risk conclusion and decide whether or not further scientific advice from the Veterinary Products Committee should be sought.<\/p>
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Similar scientific committee and processes are in place for non-pharmaceutical products (immunological and biological products).<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/1547", "label" : {"_value" : "Biography information for Lord Benyon"} } , "answeringMemberPrinted" : {"_value" : "Lord Benyon"} , "dateOfAnswer" : {"_value" : "2023-07-25", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2023-07-25T14:04:09.707Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "13"} , "answeringDeptShortName" : {"_value" : "Environment, Food and Rural Affairs"} , "answeringDeptSortName" : {"_value" : "Environment, Food and Rural Affairs"} , "date" : {"_value" : "2023-07-19", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Veterinary Medicine"} , "houseId" : {"_value" : "2"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25277", "prefLabel" : {"_value" : "House of Lords"} } ], "questionText" : "To ask His Majesty's Government, further to the Written Answer by Lord Benyon on 13 July (HL9238), what is the makeup of the Veterinary Medicines Directorate\u2019s internal scientific review committee; what process and criteria the scientific review committee follows to develop its assessment report; and what documents are provided to the scientific review committee by Veterinary Medicines Directorate assessors.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4171", "label" : {"_value" : "Biography information for Lord Black of Brentwood"} } , "tablingMemberPrinted" : [{"_value" : "Lord Black of Brentwood"} ], "uin" : "HL9488"} , {"_about" : "http://data.parliament.uk/resources/1654544", "AnsweringBody" : [{"_value" : "Department for Environment, Food and Rural Affairs"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1654544/answer", "answerText" : {"_value" : "
We have listened carefully to views expressed on pet abduction during the passage of the Animal Welfare (Kept Animals) Bill and we will take this feedback into consideration when delivering this measure.<\/p>
<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/1547", "label" : {"_value" : "Biography information for Lord Benyon"} } , "answeringMemberPrinted" : {"_value" : "Lord Benyon"} , "dateOfAnswer" : {"_value" : "2023-07-24", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2023-07-24T10:51:23.023Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "13"} , "answeringDeptShortName" : {"_value" : "Environment, Food and Rural Affairs"} , "answeringDeptSortName" : {"_value" : "Environment, Food and Rural Affairs"} , "date" : {"_value" : "2023-07-19", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Pets: Theft"} , "houseId" : {"_value" : "2"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25277", "prefLabel" : {"_value" : "House of Lords"} } ], "questionText" : "To ask His Majesty's Government, further to the remarks by Lord Benyon on 13 July (HL Deb col 1885), whether they intend to include cats at the outset of any proposed pet abduction offence.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4171", "label" : {"_value" : "Biography information for Lord Black of Brentwood"} } , "tablingMemberPrinted" : [{"_value" : "Lord Black of Brentwood"} ], "uin" : "HL9489"} ], "itemsPerPage" : 10, "page" : 0, "startIndex" : 1, "totalResults" : 3, "type" : ["http://purl.org/linked-data/api/vocab#ListEndpoint", "http://purl.org/linked-data/api/vocab#Page"]} }