Pharmacovigilance

Pharmacovigilance

Safety of Veterinary Medicinal Products (VMPs) is one of the main responsibilities of each Marketing Authorisation Holder for its products on the market.

Pharmacovigilance is the system in which Marketing Authorisation Holders, distributors, veterinarians, animal owners and pharmacists report adverse reactions and adverse events. By means of this system, detection, understanding and prevention or minimisation of the severity of adverse reactions and events can be assured in order to improve safe and rational use of VMPs in order to protect animal and human health.

 

Guidelines

Farma Research Animal Health offers required pharmacovigilance services in accordance with:

  • Eudralex VOLUME 9B
    Guidelines on Pharmacovigilance of veterinary medicinal products
  • Directive 2001/82/EC of the European Parliament and of the Council (6 November 2001)

 

Pharmacovigilance Services

Farma Research Animal Health offers:

  • QPPV
    Marketing Authorisation Holders are required to appoint a QPPV (Qualified Person of Pharmacovigilance) and a deputy QPPV both residing in the EEA and both preferable veterinarians.
    Farma Research Animal Health is able to offer this responsibility including the 24/7 availability.
  • DDPS
    Marketing Authorisation Holders are required to prepare a DDPS (Detailed Description of the Pharmacovigilance System) which describes the responsibilities of the Marketing Authorisation Holder regarding the pharmacovigilance activities concerning its veterinary products.
    Farma Research Animal Health is able to prepare a DDPS.
  • PSUR
    Periodic Safety Update Reports need to be submitted to the national authorities and/or EMA on a regular base, depending on the age of the VMP and the type of registration.
    Farma Research Animal Health is able to prepare PSURs including risk benefit assessments.

Farma Research Animal Health BV is able to assist you in building an appropriate pharmacovigilance system as well as improving the one you already have inhouse. If you would like to delegate your pharmacovigilance related obligations and responsibilities to Farma Research Animal Health, we are able to provide (deputy) QPPV, DDPS, training of MAH staff and staff of your distributors, PSURs including Signal Detection and Risk Benefit assessments, periodic literature search and AE reports. We have contacts with national Competent Authorities and the EMA on regular base and we are experienced in the use of EudraVigilance (EVVET) and the use of VeDDRA coding.

 

Quality

The pharmacovigilance services of Farma Research Animal Health are included in the Quality Assurance Program. The independent QA Unit periodically performs facility audits of the pharmacovigilance system.