Joint Ministerial Decision no. 282371 of 2006 on veterinary medicinal products.

This Decision, consisting of 96 articles and divided into ten Parts, establishes provisions concerning the circulation, control and manufacturing conditions of veterinary medicinal products, immunological veterinary medicinal products and homeopathic veterinary medicinal products in compliance with the mentioned Directives of the European Parliament and Council. The Decision defines the following relevant terms: veterinary medicine; substance, including: animal, vegetal, and human and chemical extracts; medicated feed; immunological veterinary medicine; homeopathic veterinary medicine; waiting time and maximum limits of residues of active substances; adverse effect; adverse effect in humans, as reaction occurring in humans after exposure to a veterinary medicine; serious side effect; periodic safety monitoring report; unauthorised use; wholesale of veterinary drugs; license holder; Organisation, as the European Medicines Agency; risk associated with the use of the product; risk benefit; veterinary prescription; primary packaging; labelling. This Ministerial Decision applies to veterinary medicines, including pre-mixtures for medicated animal feed, intended to be made available to Greek market and to active substances used as raw materials. In the case of veterinary drugs intended exclusively for aquarium fish, songbirds, homing pigeons, animals kept in terrariums, small rodents, weasels and rabbits kept exclusively as pets, this Ministerial Decision does not apply.
Matters covered by this Decision concern: marketing of veterinary medicine products, including: licenses and marketing authorisation, specific requirements in case of serious epizootic, exempt in case of lack of an approved veterinary medicine for species of animal that is not used for food production and for animals used for food production; specific waiting time; biological medicinal product; characteristics of the product; special provisions applicable to homeopathic veterinary medicinal products; mutual recognition procedure and decentralised procedure, including: disposing of residues; amendment of marketing authorisation terms for the protection of human or animal health and for the protection of the environment; labelling and packaging of veterinary medicinal products; possession, trade and supply of veterinary medicinal products, including: preservation of perishable products as vaccines; pharmacovigilance; penalties and standards requirements; general, final and transitional provisions, including management of waste generated by unused or expired medicines.