Licensing of veterinary medicines and vaccines is subject to a comprehensive EU legislative code under which individual products may not be marketed or used in individual Member States in the absence of the requisite authorisation. Such authorisations can only be granted following submission by the sponsoring company of an application dossier to the required standard and no such application has as yet been lodged in Ireland.
The Irish Medicines Board (IMB) is designated as the competent authority in Ireland for the grant of full marketing authorisations for veterinary vaccines. Any application for a marketing authorisation which is submitted to IMB will be examined in accordance with the legislation and associated scientific standards. However, in certain circumstances, including while a validated application for a full marketing authorisation is being considered, my Department is enabled under the EU legislation to consider an application for an exceptional, interim, authorisation, should the sponsoring choose to pursue this option at the appropriate time. My Department will examine any application for an exceptional marketing authorisation in respect of a vaccine against Schmallenberg in the context of this legislation.