The D.L.vo 95/2003 establishes these penalties for the Marketing Authorization Holder and for the Pharmacovigilance Manager in the case of violation of the above mentioned duties:
- Penalty from € 30.000,00 to € 180.000,00.
- Extra penalty from € 20.000,00 to € 120.000,00 charged to the Pharmacovigilance manager
- An additional penalty from € 10.000,00 to € 60.000,00 if the above mentioned rules on sales data transmission are be broken.
- A penalty varying from 0.1% to 1% of the income related to the drug for which a violation has been found.
- In agreement with the Ministry of Health (
if relevant for patients), the Marketing Authorization Holder has to publish the amendment related to the information already spread, for three consecutive days in the main National Journal
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