It is a basic requirement of relevant EU and national legislation that all animal medicines must be appropriately authorised and manufactured in premises which hold an appropriate manufacturing license. The authorisation regime is designed to ensure that only medicines, in respect of which it has been possible to demonstrate quality, safety and efficacy to the appropriate scientific standard, reach the market. Protection of public and animal health and welfare are the basis for these controls.
Other features of the regime include a requirement that approved medicines must be labelled in a specified manner and that such labels must show the relevant licence number. Furthermore, authorised medicines may only be sold through authorised outlets which themselves have an obligation to source products only from similarly authorised outlets.
At the time the national legislation was significantly updated by means of the Animal Remedies Regulations 1996, there was extensive publicity about the requirements, which included seminars conducted by my Department throughout the country. The requirements in relation to medicines are also reflected in quality assurance schemes which have been developed by An Bord Bia in recent years. During the course of the last month, Teagasc has issued a very helpful guide to the safe use of medicines which was drawn up in consultation with a number of organisations, including my Department, and which is available from all Teagasc offices or may be downloaded from its website.
In the final analysis, I must point to the primary responsibility on farmers to ensure that they only use authorised medicines and that they obtain them from an authorised source.