Pharmacovigilance information hub explainer
Explainer for the pharmaceutical industry on the implementation of the Veterinary Medicines Regulation relating to Pharmacovigilance.
National Competent Authority
The VMD will continue to act as the National Competent Authority for Northern Ireland and as such Marketing Authorisation Holders (MAHs) must report adverse events occurring in GB and Northern Ireland directly to us. We will then report these to the EU as required.
Where the event location can be identified, we will inform the European Medicines Agency (EMA) of those reported as occurring in Northern Ireland. Therefore, we encourage you to include a location identifier within your reports, such as the first 2 digits of reporter postcode.
Adverse Event Reporting
As a holder of an authorisation you must record and report adverse events that occur in animals, humans and the environment during or following the use or misuse of a veterinary medicine and report them to the VMD.
For Marketing Authorisations (MAs) valid in GB, Pharmacovigilance of Veterinary Medicines in Great Britain provides further guidance for Marketing Authorisation Holders and includes advice for identifying non-fatal serious animal AEs.
For MAs valid in Northern Ireland, the European Commission provides guidance on pharmacovigilance in Eudralex Volume 9b, Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use. This guidance applies to products authorised in Northern Ireland.
Where possible, you should provide a postcode for the event location so that we can determine whether the event occurred in GB or Northern Ireland.
See guidance for Veterinary Pharmacovigilance responsibilities for authorisation holders.
Periodic Safety Update Reports
We no longer participate in Periodic Safety Update Reports (PSUR) work-sharing for products authorised nationally only in GB and Northern Ireland. However, MAHs should continue to use the same harmonised data lock points as previously agreed.
PSURs for all products should be submitted as required. See guidance for Veterinary Pharmacovigilance responsibilities for authorisation holders.
Qualified Person for Pharmacovigilance location
Centrally authorised Marketing Authorisations
Centrally authorised MAs are issued by the EMA which must comply with EU Regulations and as such the Qualified Person for Pharmacovigilance (QPPV) must be located in the EU for these products to be on the Northern Ireland market.
National, decentralised and mutually recognised MAs valid in Northern Ireland
For MAs valid in Northern Ireland through national or mutual recognition procedures, the UK’s legal interpretation of the requirements of the Northern Ireland Protocol (reference: Section 20 of Annex 2), the QPPV can be located in the EU, NI or GB.
GB MAs
The QPPV for GB MAs can be located anywhere.
Pharmacovigilance inspections
The VMD will carry out inspections of all MAHs for products authorised in the UK. This includes those MAHs located outside of the UK.
We will use a risk-based approach to scheduling inspections and will conduct these remotely where appropriate. Risk basis considerations will include last EU inspection date, previous inspection findings and surveillance intelligence.
Detailed Description of Pharmacovigilance System
You do not need to update your Detailed Description of Pharmacovigilance System (DDPS) to reflect the use of Veterinary Medicines Digital Service (VMDS) for the reporting of adverse events or the route of submission of non-UK reports. We will continue to accept the current information provided for these areas.
All other changes to the DDPS, such as change of QPPV details, will still require a variation application to be submitted to the VMD.