Examples of EU authorisation in a sentence
A single EU authorisation mechanism coupled with the home-country control on the withdrawal and/or suspension of such authorisation would facilitate registration of EU operators and the coordination of the most serious enforcement measures applicable to them.
First, the current fragmentation resulting from the national dimension of the general authorisation systems is countered by introducing a single EU authorisation.
In particular, with regard to ex ante market regulation and given that each NRA is still responsible for its respective (national) markets, the modifications aim to foster greater consistency and stability across the EU with regard to NRAs' assessment of markets and imposition of regulatory obligations on holders of a single EU authorisation in order to avoid they face diverging obligations for the same market failure in each Member State where they are present.
First of all, the single EU authorisation is available to operators intending to carry out their activities on a pan-EU dimension and the regulatory obligations inherently linked to the place where a network is located or a service is provided remain to be decided by the national regulator of that Member State.
In the case of substances for which authorisation has been granted in accordance with Number 2 paragraphs 2 or 4, and preparations containing such substances, the approval number or EU authorisation number must be indicated on the label.