Dr. J.G. Beechinor:

I refer to the discussions with the Department on the implementation of the regulation. The regulation, as Deputy Carthy knows, is directly applicable but within that is the current SI 786 of 2007 which is the national legislation involved in transposing the current Directive 2001/82/EC dealing with veterinary medicines. I apologise; I know this is highly technical. The statutory instrument has to be revised in national legislation.

In doing that, the new regulation provides choices for member states as to how they want to enact certain features. For example, we can decide if we want to have an electronic package leaflet with the product, a paper copy or both. That is a matter for the Department to decide because that is its territory.

The Health Products Regulatory Authority, HPRA, regulates the products. The Department of Agriculture, Food and the Marine regulates downstream in terms of the licensed merchants, wholesalers, retailers, vets and so on. The Veterinary Council of Ireland also has a role and will be coming in later this evening-----