Dr. Paul Corkery:

They did it before this regulation came into effect. I will go back to the first question of the Senator's that I can recall. If I am not mistaken, he asked why it has taken us so long to get to where we are. The Senator might look at the European Parliament debates, which happened back in 2014. This is substantial legislation that is going through, which is bringing in big change, especially with regard to the harmonisation of products. It will make it much better for smaller markets such as Ireland to have availability. We sometimes struggle to get certain products in our small market. Some of the players are not interested in the market because it is so small. That is why we have a system of animal remedies licences through which we can allow products in form other member states. With this new legislation, that will not be required as much because we will have more access to products. The process is still under way, however.

The regulation was signed on 31 December 2018 and then it had to wait a month so we were into 2019. It is, therefore, in force but it will come into effect next January. If one looks on the European Commission's website, more than 20 delegated and implementing Acts are to be put in place to give effect to this regulation and we are only halfway there. Recently, there has been a delay with one of them and we were very satisfied that it actually went through one of the delegated Acts. It went through a scrutiny procedure in the European Parliament. It was in relation to the antimicrobials that are going to be designated for human use only. They are going to be taken out of the animal health sphere. Thankfully, it is going to be a scientific-based process. The European Centre for Disease Prevention and Control, ECDC, the European Food Safety Authority, EFSA, and the European Medicines Agency, EMA, will provide scientific justification for taking out an antimicrobial like that. That is one example of an Act that has yet to go through. An implementing Act on a model prescription also has to come through. It likely will not be there before 28 January next year. Within the regulation itself then, not everything comes into effect on 28 January next year. There are certain parts of it that are phased, for example-----