Pharmacovigilance

Pharmacovigilance legislation

The following European legislation sets out the requirements in respect of veterinary pharmacovigilance:

Note that the same pharmacovigilance requirements (including signal management) that apply to marketing authorisation holders also apply to holders of registrations of homeopathic veterinary medicinal products and veterinary medicinal products authorised in accordance with Article 5(6) of Regulation (EU) 2019/6 (certain species kept exclusively as pets).

Pharmacovigilance guidance documents

A guideline on veterinary good pharmacovigilance practices (VGVP guideline) is available from the European Medicine Agency’s website and is set out in six modules as follows:

Adverse events

Relevant information and guidance on the handling and processing of reports of suspected adverse events is available from the following sources:

EudraVigilance

Guidance notes on the use of VeDDRA terminology for reporting suspected adverse reactions in animals and humans

VICH GL42 – Pharmacovigilance of Veterinary Medicinal Products – Data Elements for Submission of Adverse Event Reports

EU VICH adverse event report implementation guide

Pharmacovigilance System Master File (PSMF)

From 28 January 2022, a Pharmacovigilance System Master File (PSMF) must be in place for all veterinary medicinal products (including homeopathic veterinary medicinal products and veterinary medicinal products authorised in accordance with Article 5(6) (certain species kept exclusively as pets).

The PSMF replaces what was previously known as the Detailed Description of the Pharmacovigilance System (DDPS).

For new applications for marketing authorisation submitted from 28 January 2022, the application dossier should include a summary of the PSMF. The format and content of the PSMF is set out in Commission Implementing Regulation (EU) 2021/1281 and described in VGVP module entitled ‘Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files’.

Pharmacovigilance inspections: veterinary

In order to determine that marketing authorisation holders (MAHs) of veterinary products comply with pharmacovigilance requirements established by EU legislation, and to facilitate compliance, pharmacovigilance inspections are performed of veterinary MAHs or any firms employed to fulfil the MAH duties.

During these inspections HPRA personnel review the procedures, systems, personnel and facilities in place and determine their compliance with the requirements.

Product-related pharmacovigilance inspections are primarily focused on product-related pharmacovigilance issues, including product-specific activities and documentation, rather than a general system review. Some aspects of the general system may still be examined as part of a product-related inspection.

Pharmacovigilance inspections may be performed on a routine basis or may be scheduled in response to a request from another department or committee of the HPRA where there is a specific cause for concern with respect to compliance with guidelines or regulations.  A request for a routine or triggered inspection may also be received from the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP).