Post-authorisation (veterinary medicines)

The European Medicines Agency (EMA) provides scientific and regulatory guidance to pharmaceutical companies whose veterinary medicinal products have been authorised in Europe. This is known as the post-authorisation stage of the product lifecycle. The information in this section sets out the responsibilities of marketing authorisation holders in areas such as pharmacovigilance, applying to vary a marketing authorisation, submitting product data to EMA and reporting product defects or recalls.