Under European and Irish legislation, before a medicine can be placed on the Irish market the manufacturer has to seek an authorisation from the Irish Medicines Board (IMB) or in the case of certain medicinal products, the European Medicines Agency (EMA). A determination on an application for authorisation of a medicine is based on a rigorous scientific assessment of the application against legal and regulatory requirements.
The IMB has not received any application to authorise CRAZE and therefore cannot state definitively what it contains. However, having reviewed the available literature, the IMB is of the view that the product CRAZE would be considered to be a medicinal product in Ireland requiring a marketing authorisation to be issued by the IMB or by the EMA.