Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019

These Regulations concern medicines and allied substances (marketing authorisation of medicines). It provides that a person who intends to place a medicine on the market shall apply to the Authority for a marketing authorisation in Form I set out in the Schedule on payment of the fee set out in the Medicines and Allied Substances (Fees) Regulations, 2016. A person may sell or supply veterinary medicine under the following categories: (a) prescription only medicine - veterinary; (b) pharmacy medicine veterinary; and (c) general sale medicine veterinary. A holder of a marketing authorisation shall label the primary package or container of a medicine to show, for instance, the indications and directions for use, including the target species in case of veterinary medicine, and a statement “For Veterinary Use Only”, amongst other things. An original container of a medicine shall be accompanied by a package insert printed in legible letters in English stating, among others, the indications, in case of a veterinary medicine, specifying target species; dosage and directions for use, in case of a veterinary medicine, specific to each target species; and precautions and warnings, including withdrawal periods, in case of a veterinary medicine used in food producing animals.