Disclosing Generics Applications
The Italian Medicines Agency (AIFA) has issued new guidelines on
its future policy on the disclosure of generics (Gxs)
applications.
AIFA stated that "further to consultations with Italian
and European institutions, as well as the industry and the Italian
courts" (presumably the Italian administrative courts
where cases were recently brought by leading pharmaceutical
companies), AIFA has decided to change the procedure whereby AIFA
will process patent holders' requests for information on
Marketing Authorisation (MA) applications filed by generics
manufacturers.
From October onwards, AIFA will publish a list of all the active
substances for which MA applications have been filed in accordance
with Article 10(1) and 10(3) of Directive 2001/83/EC. According to
AIFA, publishing that list will meet the requirements of the
Italian Freedom of Information Act (Law 241/1990), according to
which affected third parties are entitled to be
