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Response to Freedom of Information Request ATI0732
The Veterinary Medicines Directorate (VMD) is DEFAR's department for authorising and controlling Medicines for animals in the UK.
VMD carry out pharmacovigilance, which includes recording Adverse Reaction Events
The following email is from 2021. As is explained in the email, more recent figures might not be available until 2024. However, I have submitted further yearly FOI requests, and updated the spreadsheets accordingly
Dear Mark,
Thank you for your e-mail of 17 September 2021.
We are dealing with it under the Freedom of Information Act (FOIA) 2000.
Your Request
You asked “I'd like to update my Dorsetdog and Lepto websites with the latest figures please for adverse event reactions to canine vaccines. Below is the table that you provided for official figures up to 2017, and I'd appreciate it if you could add the figures for the missing years up to latest figures that you have.”
Our Reply
All marketing authorisation holders (MAHs) must submit periodic safety update reports (PSURs) to us, the Veterinary Medicines Directorate (VMD), at intervals set in legislation, varying between 6 months and 3 years depending on how long a product has been on the market. These reports include data on the number of doses of the product that have been sold by the MAH during the period that the report covers and the number of adverse events.
The FOIA requires us to help people obtain the information they are looking for, and PSURs are a comprehensive source of such information.
We have updated the table where we have the complete dataset for a year, depending on the frequency of PSUR submissions for the products involved. We have highlighted the new information in yellow.
The information you requested is as follows:
Sales and Adverse reaction figures to vaccines which do not include Lepto
Sales and Adverse reaction figures to vaccines which do not include Lepto
Sales and Adverse reaction figures to vaccines which include 2 strains of Lepto
Sales and Adverse reaction figures to vaccines which include 2 strains of Lepto
Sales and Adverse reaction figures to vaccines which include 3 or 4 strains of Lepto
Sales and Adverse reaction figures to vaccines which include 3 or 4 strains of Lepto
These figures start in 2016, as that is when three manufacturers were making Lepto vaccines of more than 2 strains. VMD are not allowed to release figures where only two manufacturers are making a product, as it may give the manufacturers confidential information and advantage.
Information releasable to the public
In keeping with the spirit and effect of the FOIA and the government’s Transparency Agenda, we may place this request on GOV.UK, in due course. We will not place information identifying you on the GOV.UK website.
Copyright
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Most documents produced by Defra will be protected by Crown Copyright. Most Crown copyright information can be re-used under the Open Government Licence. For information about the OGL and about re-using Crown Copyright information please see The National Archives website.
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Total Sales and recorded Adverse Reaction events - 2012 onwards
Total Sales and recorded Adverse Reaction events - 2012 onwards
This total is for all Lepto and DHP vaccines sold, and Adverse events to them in the UK
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