Update on pharmacovigilance activities concerning veterinary medicinal products in the European Union during 2017

Notice type: Advisory

Date: 05/04/2018

public bulletin on suspected adverse reactions to veterinary medicinal products is produced by the European Medicines Agency (EMA) each year. It is aimed at informing veterinarians and the public of the main outcome of pharmacovigilance or post-marketing surveillance activities for veterinary medicinal products (VMPs) during the year (in this case, 2017).  The bulletin was published by the EMA on 14 March 2018.

Product name or type:
Veterinary medicinal products

Target Audience:


Veterinary practitioners, pharmacists, retailers of veterinary medicines, animal owners.


Problem Or Issue:
The bulletin summarises recommendations to amend safety warnings and highlights ongoing monitoring of several centrally authorised products (CAPs). A summary of the discussions and agreements at European level by the network of EU medicines agencies regarding pharmacovigilance issues concerning nationally authorised VMPs is also included.

Background Information Or Related Documents:

All veterinary medicinal products carry certain risks and it is therefore important that prescribers and users of the medicines are aware of the potential issues that can arise.

The HPRA and the EMA continually monitor the safety and efficacy of veterinary medicinal products on the market. When new information becomes available that affects the benefit risk balance of the medicine, the information can lead to regulatory action to mitigate any adverse or untoward event. Reporting of any cases of suspected adverse events, or lack of expected efficacy, can therefore help to safeguard animal health and welfare, and prevent untoward effects in animals or persons using the products concerned.

Actions To Be Taken:


Veterinary practitioners and health care professionals should note the contents of the bulletin.


Further Information:
For information on how to report an adverse event associated with a veterinary medicinal product, please click this link.

« Back