Mr. John Lynch:

It is correct that within the European medicines directive, which has been transposed, that the use of exempt or unauthorised products must be to meet the special needs of patients under the direct responsibility of a medical practitioner. The scheme has been in operation since 2008 and it is a recognition that we are a small market. There can be occasions where the authorised product is not available or it is simply a niche product and it is not commercially viable for a company to put in an application for a marketing authorisation.

Authorised wholesalers whom we inspect and authorise can source exempt products generally when the products are authorised in other member states and then can bring them into the country. They notify the Health Products Regulatory Authority of the receipt of those products and then they can supply hospitals, pharmacies or practitioners, specifically for patients under their care. The value of that is while a product is not authorised in our market, in the event that we get a notification from other member states for a recall of that product, we can at least check our database of notified exempt products and initiate a recall through the wholesaler who has sourced the product.