On the AIFA web site (www.agenziafarmaco.it), on the 15 July 2010 a transmission of a list of medicines that result as having expired and for which no application for an extension to the expiry has been submitted, as is provided for in the AIFA guideline to the “Sunset Clause”, has been publishedAs such, the AIFA requests that marketing authorization holders supply within 10 days of the publication of the above transmission, any divergent opinion to this advanced warning, supplying valid evidence to demonstrate the commercialization of the medicine before the expected expiry date of the MA, bearing in mind the need to insert sales data into the "Sistema della Tracciabilità” (Traceability system).  If this evidence of the commercialization has not been completed within the abovementioned timelines, the MA of the medicine on the list will expire as per the law. All communications must be transmitted to the e-mail This e-mail address is being protected from spambots. You need JavaScript enabled to view it  

Last Updated (Thursday, 22 July 2010 09:22)