Guideline VII Communication
Updated 29 May 2024
Applies to England, Scotland and Wales
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This publication is available at https://www.gov.uk/government/publications/pharmacovigilance-of-veterinary-medicines-in-great-britain/guideline-vii-communication
1. Introduction
Communication between stakeholders regarding veterinary pharmacovigilance information is crucial to ensure the appropriate dissemination of this information. All relevant stakeholders must be informed on important changes to authorised veterinary medicinal product (VMP) information in order to safeguard human and animal health and the environment.
Communication to stakeholders regarding veterinary pharmacovigilance issues should be considered when new relevant information arises and needs to be communicated more urgently than through a routine procedure, such as an update to product literature.
2. Objective of communications
The main objective of pharmacovigilance communications is to convey relevant, clear, accurate, consistent messages to the relevant stakeholders so they can be kept up to date and take action when appropriate.
This could include important new veterinary pharmacovigilance information such as:
- new adverse events or changes in severity, characteristics, or frequency of adverse events
- confirmed signals
- new information in the product literature of a VMP, such as a contraindication being added or additional precautions to be taken by the person administering the product to an animal
3. Communication between stakeholders
There should be collaboration and coordination between Marketing Authorisation Holders (MAHs) and the VMD regarding pharmacovigilance communications, as this is crucial for delivering consistent information.
When making an announcement regarding pharmacovigilance concerns to veterinarians or the general public, an MAH must give the VMD prior or simultaneous notice.
This includes any planned communications about safety concerns due to quality issues, including notifications or advice to veterinarians in the event of a product or batch defect or withdrawal of a product from the market for safety reasons.
This includes any format for the announcement, including letters, bulletins, or e-mails.
Information must be objectively presented and must not be misleading.
The MAH does not need to notify VMD when discussing individual adverse events with reporters or when responding to individual enquiries.
4. Freedom of Information requests made to the VMD
The VMD is committed to follow the legislation relating to freedom of information act (FOIA) requests including our commitment not to disclose information where that information is properly covered by one of the FOIA’s exceptions. We will deal with data requests on a case-by-case basis and will consult with the data ‘owners’ where necessary. The VMD will seek the views of those that provided us with the data on what harm will fall if we disclose the information and decide if it’s likely to be actual and reasonably foreseeable on the basis of the MAH’s case.
The final decision on whether we release the information rests with the VMD. However, we will take MAH’s views into account when we make this decision.