On 25/05/2013,
you requested for the version in force on 25/05/2013
incorporating all amendments published on or before 25/05/2013.
The closest version currently available is that of 31/03/2005.
8. The exemptions granted under this Order in respect of any orphan drug shall cease to apply —
(a)
if, in the opinion of the licensing authority, the incidence of any rare disease for which the drug is used has increased significantly in any one year; or
(b)
as soon as an application for a product licence for the drug has been approved by the licensing authority.