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;

the number, date and country of the first Marketing Authorization in the European Union (if different from Italy);

if item 6 is applicable, the national legal provision under which the first Marketing Authorization in the EU has been granted (e.g. the British Medicines Act of 1968);

if item 6 is applicable, a copy of the notice publishing the first Marketing Authorization for the EU in the national Official Gazette, clearly showing the date and number of the said Official Gazette - for SPCs for plant protection products, if no such notice is published in the national Official Gazette, a copy of any official document proving that the Authorization has been issued; should said notice be in a language different from English or French, a translation into one of these languages will simplify the work of Italian Attorneys in providing the required Italian translation;

if item 6 is applicable, the Applicant's confirmation about the identity of the authorized product, i.e., the commercial name and name of the active ingredient(s)/active substance(s) of the product corresponding to the first Marketing Authorization in the EU;

a Power of Attorney simply executed by the Applicant, or by a legal representative of the applicant company (no legalization is required);

the confirmation by the Applicant that the basic patent is in force;

the confirmation by the Applicant that no other Italian SPCs have been obtained on the same product besides the one which is being applied for;

in the event that the Italian Marketing Authorization has not been granted directly to the holder of the patent, the confirmation by the latter that the said Authorization has been obtained by the holder thereof under his/its consent.