European Parliament 18 July 2001, WRITTEN QUESTION E-2144/01 by Jo Leinen (PSE) to the Commission. Orphan Drug Directive - marketing authorisation for the treatment of Fabry's Disease.

Regarding new drugs already in circulation outside the Community, the fact that they are already authorised in another third country does not imply that the EMEA or the reference Member State in the context of the decentralised procedure are obliged to proceed to their approval.