Taking into account the main changes that should be made to the existing rules, and aiming to improve the functioning of the internal market, a regulation is the appropriate legal instrument to replace Directive 2001/82/EC in order to lay down clear, detailed and directly applicable rules.
Agus na príomhathruithe ar cheart iad a dhéanamh ar rialacha atá ann cheana á gcur san áireamh, is rialachán an ionstraim dhlíthiúil iomchuí a chuirfear in ionad Threoir 2001/82/CE chun rialacha soiléire, mionsonraithe a leagan síos, ar rialacha iad a bheidh infheidhme go díreach.