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National Registry of Orphan Drugs

The National Registry of Orphan Drugs contains data on the diagnosis and follow-up of the patients treated with orphan medicinal products authorized at a centralized level by the European Medicines Agency (EMEA) and reimbursed by the Italian National Health Service (NHS).

The National Registry of Orphan Medicinal Products, instituted at the Istituto Superiore di Sanità, prepares the data collection forms for each rare pathology and related medications, and collects, verifies and analyses the data sent by the regional Centres which are authorized to distribute these drugs.

This register aims at having total coverage of the national territory. This means that it will interact with all the Italian Centres that are authorized to dispense and prescribe orphan medicinal products. In every phase of collection, elaboration and filing of the data, protection of confidentiality of personal data is guaranteed in compliance with current legislation (Legislative Decree 196/2003).

Published 05-02-2008 in Registries , last update 22-05-2008


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