The new template includes a new section on any restrictions on the use of antimicrobials and antiparasitic veterinary medicines to reduce the risk of developing resistance. This will support prescribing #veterinarians and will strengthen the efforts towards responsible and prudent use of #antibiotics.
The new template also points out the environmental considerations that must be addressed in the product information, as foreseen by the Veterinary Medicinal Products Regulation. For example, marketing authorisation holders must include now information on special precautions for the protection of the environment and to explain how to correctly dispose of unused or waste veterinary medicinal products.
Such information will better guide veterinarians and pet owners in defending the environment when using medicines in animals. https://lnkd.in/e9rbhyY
The European Medicines Agency’s (EMA) provides templates for product information for use by applicants and marketing authorisation holders of veterinary medicines. EMA’s Working Group on Quality Review of Documents (QRD) develops, reviews and updates these templates.
The information contained in these documents is non-exhaustive. Companies should refer to all relevant European Union legislation and guidelines when drawing up applications. It is the company’s responsibility to ensure that the product information complies with all applicable requirements.
Applicants should use: