Veterinary pharmacovigilance

What is pharmacovigilance?

Veterinary pharmacovigilance is the process of monitoring veterinary medicinal products after they have been placed on the market, in order to identify, assess and report any undesirable effects. Its main purpose is to ensure the safety of medicinal products used on animals, and to protect public health and the environment.

The aims of pharmacovigilance:

• Rapid detection of undesirable effects: post-marketing monitoring helps to identify rare side-effects, or side effects that are specific to certain breeds or groups of animals.
• Assessment of medicinal product safety: this includes their safety for animals treated, products of animal origin, and people who come into contact with these medicinal products.
• Risk management: if undesirable effects are detected, measures are taken, such as adding precautions to package leaflets, modifying indications, or withdrawing the medicinal product from the market if necessary.
• Improved benefit-risk balance: pharmacovigilance constantly assesses the benefit-risk balance of medicinal products to ensure that they are always in compliance with safety requirements.

Why is pharmacovigilance needed?

Although medicinal products are tested before being placed on the market, some rare undesirable effects only become apparent after prolonged use.

Who is responsible for pharmacovigilance?

The marketing authorisation holder (MAH) is responsible for monitoring the veterinary medicinal product that it holds the authorisation for, and must comply with the applicable good pharmacovigilance practices. The veterinarian is responsible for reporting any undesirable effects that occur when the medicinal product is administered. Finally, the animal owners have an important role to play in reporting any problems or unexpected effects associated with the use of the medicinal product, either to the veterinarian or directly to the distributor of the veterinary medicinal product shown on the product packaging.

What is veterinary pharmacovigilance?

Veterinary pharmacovigilance seeks to (i) ensure the safety of veterinary medicinal products and vaccines used on animals, and (ii) protect products of animal origin, humans who come into contact with veterinary medicinal products, and the environment.

Which aspects are monitored?

• Animal safety
• Safety of products of animal origin
• Safety of people who come into contact with veterinary medicinal products
• Environmental safety