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1652132

registered interest
date	11/07/2023
answering body	Department for Environment, Food and Rural Affairs
answering dept id	13
answering dept short name	Environment, Food and Rural Affairs
answering dept sort name	Environment, Food and Rural Affairs
hansard heading	Veterinary Medicine
house id	2
legislature	25277 pref label House of Lords
question text	To ask His Majesty's Government what process the Veterinary Medicines Directorate uses to determine whether to grant an application to vary the marketing authorisation of a prescription-only veterinary medicine to allow over-the-counter sale.
tabling member printed	Lord Black of Brentwood
uin	HL9236
answer	answer is ministerial correction date of answer 13/07/2023 answer text <p>Veterinary medicine approvals are assessed against statutory criteria for safety, quality and efficacy, as set down in the Veterinary Medicines Regulation. We assess the risks of providing products over-the-counter against the benefits and this is taken to the VPC for independent consideration.</p> answering member printed Lord Benyon question first answered 13/07/2023 16:40:17 answering member 1547 label Biography information for Lord Benyon
tabling member	4171 label Biography information for Lord Black of Brentwood

1652133

registered interest
date	11/07/2023
answering body	Department for Environment, Food and Rural Affairs
answering dept id	13
answering dept short name	Environment, Food and Rural Affairs
answering dept sort name	Environment, Food and Rural Affairs
hansard heading	Veterinary Medicine
house id	2
legislature	25277 pref label House of Lords
question text	To ask His Majesty's Government what criteria the Veterinary Products Committee uses to recommend whether an application to vary the marketing authorisation of a prescription-only veterinary medicine to allow over-the-counter sale be granted.
tabling member printed	Lord Black of Brentwood
uin	HL9237
answer	answer is ministerial correction date of answer 13/07/2023 answer text <p>The VPC review VMD’s assessment and conclusion (they may question the assessors if necessary) and provide an opinion as to whether they agree (or not) with the VMD’s conclusion to grant (or not) the lower distribution category.</p><p> </p><p>The VMD consider the VPC’s advice and make a final decision as to whether an application to vary the marketing authorisation of a prescription-only veterinary medicine to allow over-the-counter sale is granted.</p><p> </p><p>The criteria for the VMD’s decision are that:</p><ul><li>the non-prescription category must be legally permitted, and</li><li>the benefit-risk balance must remain favourable, i.e. any potential increased risks to animal health, public health or the environment, due to increased availability and absence of veterinary point of supply advice, can be suitability mitigated.</li></ul> answering member printed Lord Benyon question first answered 13/07/2023 16:39:01 answering member 1547 label Biography information for Lord Benyon
tabling member	4171 label Biography information for Lord Black of Brentwood

1652134

registered interest
date	11/07/2023
answering body	Department for Environment, Food and Rural Affairs
answering dept id	13
answering dept short name	Environment, Food and Rural Affairs
answering dept sort name	Environment, Food and Rural Affairs
hansard heading	Veterinary Medicine
house id	2
legislature	25277 pref label House of Lords
question text	To ask His Majesty's Government what documents are provided by the Veterinary Medicines Directorate to the Veterinary Products Committee to enable them to assess whether an application to vary the marketing authorisation of a prescription-only veterinary medicine to allow over-the-counter sale can be granted.
tabling member printed	Lord Black of Brentwood
uin	HL9238
answer	answer is ministerial correction date of answer 13/07/2023 answer text <p>The VMD provides the VPC with the assessment report (as peer-reviewed and agreed by the internal scientific review committee). The assessment report includes a benefit-risk assessment and conclusion as to whether the VMD consider that the variation to lower the distribution category should be granted.</p> answering member printed Lord Benyon question first answered 13/07/2023 16:39:18 answering member 1547 label Biography information for Lord Benyon
tabling member	4171 label Biography information for Lord Black of Brentwood