The sentence of a regional court on July 24th 2012 upheld an appeal made by a pharmaceutical company against the refusal by the Italian Medicine Agency (AIFA) to grant access to the documentation reporting the holders of MA applications for generic drugs.
AIFA postponed the documentation access to the end of the preliminary phase, on the base of the provisions established by the same Agency in a communication dated September 16th 2010, i.e. the chance to access documentation only after the CTS (Scientific Committee) or CPR (Price and Reimbursement Committee) have expressed their opinion.
The regional court upheld the appeal declaring such postponement as arbitrary, since the AIFA communication only intends to avoid any delay in the issue of generic MAs due to any court appeal. The court also declared the postponement as unjustified in case the access requests do not hinder the continuation of administrative activities.
Moreover, the court established that the list of holders which submitted a MA application should be communicated to the company concerned and used to forward a communication on the expiry date of complementary protection certificates underlining that equivalent drugs cannot enter the market before the day after the expiry.
