Mr. Colm Forde:

I am happy to take on the first part of that question. In our opening statement, we outlined the legislative developments. I think I referred to this earlier but when the Department of Agriculture, Food and the Marine officials were negotiating this particular regulation - if members have the opening statement in front of them, it comes under the heading of EU and domestic legislative position of AVMPs - and when the 2019 regulation was finalised, it would have allowed for antiparasitics to still be sold by licensed merchants without requiring a prescription. One of the issues that has not been touched on too much is Article 33 of the regulation. It states all veterinary medicinal products for food producing animals must require a prescription but there are certain exemptions to that. Certain products can be made available without a prescription if there is no evidence of resistance, no harm to humans or no environmental damage, in addition to a number of other criteria. It was on the basis that we met those criteria historically that antiparasitics could be sold without using a veterinary prescription.

Since the regulation was finalised, the Health Products Regulatory Authority has become the competent authority for analysing medicines. It determines whether medicines are working and doing exactly what they should be doing, and what route of sale they should have. It analyses-----