EMA: Guideline on user safety of topically administered veterinary medicinal products

Applications for marketing authorisations for veterinary medicinal products (VMPs) in the European Union are issued in accordance with Directive 2001/82/EC as amended by Directive 2004/28/EC and Directive 2009/9/EC. This legislation requires that applications for pharmaceutical veterinary medicinal products must provide safety documentation. Annex I of Directive 2001/82/EC (replaced by the Annex to Directive 2009/9/EC) states that “the safety documentation shall show the potential risks which may result from the exposure of human beings to the veterinary medicinal product, for example during its administration to the animal\".