Veterinary Pharmacovigilance

The Marketing Authorisation Holder’s should ensure that it has an appropriate system of pharmacovigilance in place in order to assume responsibility and liability for its medicinal products for veterinary use (VMPs) on the market and to ensure that appropriate action may be taken, when necessary.

The MAHs should ensure that they have an appropriate system of pharmacovigilance in place, in accordance with Article 74 of Directive 2001/82/EC and Article 48 of Regulation (EC) No. 726/2004.

We can to help in this area from adverse reaction case processing; answering veterinary enquiries into the product usage (veterinary information); understanding the varied legislation; providing aggregate data assessments (safety reviews); Periodic Safety Update Report (PSUR) writing; helping to keep labeling up to date; literature searching for possible adverse reactions.

We can help meet the regulatory, compliance and safety obligations for Veterinary Pharamcovigilance.

For more information please contact us at enquiries@pharmafile.ie