FILING REQUIREMENTS

full details about the Applicant(s) - the Applicant(s) must be the holder(s) of the "basic patent" or his (their) successor in title;

identification of the product to be covered by the SPC, i.e. its commercial name and the name of the active ingredient(s)/active substance(s) thereof;

full details of the basic patent (Italian or European patent valid in Italy), i.e. the number and date of the patent application, the number and date of the granted patent and the title of the invention;

a copy of the first Marketing Authorization in Italy for the concerned product;

a copy the Summary of the Product Characteristics as approved by the Italian Board of Health - this document is generally part of the Marketing Authorization mentioned under item 4;