This Regulation defines the procedures in the pharmacovigilance system for veterinary medicinal products in case of adverse reactions that are not officially classified as serious.
The person responsible for placing on the market of veterinary medicinal products shall ensure that the suspected unexpected adverse reactions, which are not classified as serious but occurring in the Republic of Croatia, shall be notified to the competent authorities of all Member countries (article 2). Article 3 sets out rules regrading the periodic notification, security notices and related data collection deadlines.