Links to national authority websites
Public information on compassionate use programmes will be available soon. See below for who to contact in your national authority
France probably has the most elaborated scheme for compassionate use programmes, called A.T.U. (Temporary Use Authorisation).
The A.T.U. is a legal tool, which was implemented in 1994 (in fact even earlier). Between 1994-2011, more than 1000 medicinal productswere authorised in France, of which 230 were subject to ATU.
On average, ATU permits the product to be available 10-12 months before a marketing authorisation is granted. The main therapeutic areas where ATUs are granted are oncology-haematology, central nervous system, infectious diseases including AIDS, and metabolism (rare diseases).
For named-patient compassionate use (nominative ATUs), 25 000 ATU were granted in 2011 (initial and renewal) and 460 refused. This represented 18 000 patients (30% children).
For cohort ATUs, more than 130 active substances have been authorised for a Compassionate Use Programmesince 1994. For rare diseases in particular, 70% of the authorised Orphan Medicinal Products were available via an ATU before the marketing authorisation, on average 34 months before the marketing authorisation.
Updated 07/06/2013
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For rare diseases in France, 70% of the authorised Orphan Medicinal Products were available via an ATU before the marketing authorisation, on average 34 months before the marketing authorisation).
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Page created: 30/10/2013
Page last updated: 30/09/2016