Report pharmacovigilance data for veterinary medicines
Service for Marketing Authorisation Holders.
The VMD Industry Pharmacovigilance Reporting Service is for business use only.
Before you can use the service, you must register.
View the guidance on this page before starting the registration process. Once you have read the guidance, you can apply to register by emailing PHVReportingService@vmd.gov.uk.
Once you have successfully registered, you can sign in using the Start button.
What is the VMD Industry Pharmacovigilance Reporting Service
The VMD Industry Pharmacovigilance Reporting Service is a digital platform that provides:
- an upload function that allows marketing authorisation holders to upload Benefit-Risk Submission Reports, Pharmacovigilance Sales Submissions, signal notifications and dose factor justification documents
- adverse event reporting facility that allows marketing authorisation holders to submit adverse event files in XML VICH format
It is a beta service, with continual testing and improvements being made.
Marketing Authorisation (MA) holders (or proposed holders) who wish to continue to submit manual adverse event reports using the Veterinary Medicines Digital Service (VMDS) adverse events reporting (AER) should do so using the Veterinary Medicines Digital Services.
MA holders who wish to continue using secure messaging and VMDS AER rather than the VMD Industry Pharmacovigilance Reporting Service, can do so.
Who can use this service
MA Holders
Holders (or proposed holders) of marketing authorisations and other licencing certificates including animal test certificates (all types), veterinary homeopathic registrations, and autogenous vaccine authorisations.
MA holders can access and use all parts of the VMD Industry Pharmacovigilance Reporting Service.
This service is not for use by:
- pet owners
- members of the public to report a suspected problem with an animal medicine or pet exposure to a human medicine. They will need to report a problem with an animal medicine using the public facing digital adverse event reporting service.
Consultants or Agents
Consultants cannot register independently unless already registered for the Veterinary Medicines Digital Service. They must be invited by a company that they are doing work for to join that company’s account. This means they may be invited into more than one company account. The service will recognise consultants, which will help ensure they are only given access to the information and parts of the service that they are permitted to see and use.
Registering for the service
Before you can use the VMD Industry Pharmacovigilance Reporting Service, you must register.
We will ask you to provide a named person for the service, the name and company number of the MA holder that you will be using the service on behalf of and how many licences are required and for who. If you will be submitting XML files, we will ask you to confirm your sender ID. We will reconcile Product Group Codes (PGCs) where these apply.
Depending on the information provided, we may contact you for further information prior to registration.
If you try and register a company that is already on the system, the named person for the service for your company will be informed. It will then be up to them to invite you to use the service.
Named person for the service
There must be a named person for the service. This person will be the main point of contact for registration and troubleshooting.
This person can request approval to add and remove users. These users will not need any additional verification. This element is entirely at the discretion of the named person for the service or company account.
Users can be anyone you wish to have access such as company staff, consultants, and contractors.
Users can be invited to use more than one company account.
Accessing and using the service
Once registered, you will receive a confirmation email. You will then be able to sign in and use the service.
As the named person for the service, if you are not already registered for the Veterinary Medicines Digital Service, you will need to provide some information about yourself and the company including:
- your company name and number
- official business address; the legally registered address
- name and contact details of a colleague who can verify your identity and confirm your connection to the company
VMD checks
Using the information provided, we will check to make sure:
- it is appropriate for your company to use the service
- you are a legitimate representative for that company
Benefit-risk reports, signal notifications and dose factor justification documents
Using the submissions part of the service, MA holders (or proposed holders) will be able to submit:
- Post-marketing reports
- Benefit-Risk Submission Reports (BRSRs)
- Pharmacovigilance Sales Submissions (PSSs)
- Signal notifications
- Dose factor justification documents
Upon request, you may be asked to upload other data or information that cannot be sent using the service.
Guidance on when you are required to submit these reports, and how to do so can be found at Pharmacovigilance of Veterinary Medicinal Products in Great Britain - GOV.UK and Benefit-risk report (BRR) and signal notification submissions - GOV.UK.
Adverse events
Using the submissions part of the service, MA holders (or proposed holders) will be able to submit XML adverse event files.
Marketing Authorisation (MA) holders (or proposed holders) who wish to continue to submit manual adverse event reports using VMDS AER should do so using the Veterinary Medicines Digital Services.
Terms of use, cookies, data and privacy
To use this service, you will need to read and accept our terms and conditions:
By using this service, you and your organisation agree to these terms of use.
Check these terms and conditions regularly. We can update them at any time without notice.
The VMD Industry Pharmacovigilance Service is hosted by Ennov on behalf of the Veterinary Medicines Directorate. The service uses a strictly necessary cookie to store information on your computer for the website to work (JSESSIONID for user management and maintenance, expires when the browser is closed).
By using the service, you are confirming that you are content for Ennov, on behalf of the Veterinary Medicines Directorate, to temporarily use these cookies to apply these survey functions. For more detailed information on how Ennov handles data, read the Ennov privacy policy.
Support
Full guidance on how to use the service is provided within the service.
If you need any technical assistance, contact us at: PHVReportingService@vmd.gov.uk.
If you have a non-technical query, contact the relevant pharmacovigilance area:
- For adverse event reporting: adverse.events@vmd.gov.uk
- For BRSR, PSS, signal notification and dose factor justification document reporting: psur.queries@vmd.gov.uk
Feedback
This service is a beta service. Feedback can be provided at VMD Industry Pharmacovigilance Reporting Service. This link is also available within the service.