ITALY Law and Practice Contributed by: Daniela Ampollini, Luca Pellicciari, Elena Mannini and Andrea Beltrame, Trevisan & Cuonzo
for a medicinal product may be further extended for six months if the medicinal product has to undergo a series of clinical trials under the Pae - diatric Investigation Plan (PIP), ie, a research and development programme aimed at providing clinical data to verify the usability of the medici -
out the criteria and the procedure for the desig - nation of a medicinal product as an orphan drug and attributes the granting of said designation to the Committee for Orphan Medicinal Prod - ucts (COMP) of the European Medicines Agency (EMA). According to said provisions, for a medic - inal product to be designated as an orphan drug, the following requirements shall be met: • the medicinal product shall be intended for the diagnosis, prevention or treatment of a life-threatening or chronically/seriously debili - tating condition affecting: (a) no more than five in ten thousand per - sons (calculated at the EU level); or (b) in any event, a relatively small population, so it is unlikely that, without incentives, the marketing of the medicinal product in the EU would generate sufficient returns to justify the necessary investment; • there are no satisfactory methods of diagno - sis, prevention or treatment of the condition in question that have been authorised in the EU, or if such method exists, the medicinal prod - uct is of significant benefit to those affected by that condition. In order to speed up the availability of orphan drugs in Italy, Article 12(3) of the Balduzzi Decree (Law Decree No 158/2012, as amended by Law No 189/2012) provides that applications for clas - sification and price reimbursement relating to orphan drugs and/or drugs of exceptional ther - apeutic importance may be submitted as soon as a positive CHMP opinion is issued, ie, also prior to the granting of the marketing authori - sation itself. In addition, such applications for classification and price reimbursement relating to orphan drugs or drugs of exceptional thera - peutic importance are examined by the Italian Medicines Agency (AIFA) as a matter of priority
nal product in the paediatric field. 4.3 Paediatric-Use Marketing Authorisations
Paediatric use marketing authorisations (PUMAs) are available in Italy, in line with Regulation (EC) No 1901/2006, which lays down rules on medici - nal products for paediatric use. PUMAs have been designed to promote the paediatric development of already authorised medicinal products, which are no longer covered by an SPC or a patent qualifying for an SPC and are dedicated marketing authorisations cover - ing indication/s and formulation/s for medicines developed exclusively for use in the paediatric population. According to Articles 30 to 38 of Regulation (EC) No 1901/2006, (i) PUMA applications have automatic access to the centralised procedure if the applicant chooses this route, (ii) the develop - ment of a PUMA must follow a paediatric inves - tigation plan (PIP), and (iii) PUMAs benefit from the period of 8 plus 2 years of data and market protection. In addition, a medicinal product for which a PUMA has been granted may retain the name of another medicinal product containing the same active substance for which the same holder has been granted an MA for use in adults. 4.4 Orphan Medicines Extensions Extensions for orphan medicines are available in Italy, in line with Regulation (EC) No 141/2000 of the EU Parliament and of the Council, and Com - mission Regulation (EC) No 847/2000, which set
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