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Process Worldwide-PharmaTEC 01-2003

Vignette becomes mandatory
Italy plans to use vignettes to prevent counterfeiting of pharmaceutical products


Italy has set aggressive goals for protection against counterfeiting of pharmaceutical products. Vignettes and a central database will be introduced in the near future to put a stop to piracy in the pharmaceutical industry.
For a number of years now, the Italian government has been studying ways to provide counterfeit protection for pharmaceuticals that have been produced for sale in the Italian market. Initial information about the intended protection program was released in 2000, and the Italian government has officially released the decree dated August 2nd, 2001. The press release on February 21st, 2003 revealing future plans for a central database is regarded as further confirmation of the government’s intentions. The goal of the decree is to achieve total traceability and transparency of the commercial channels used for every medicine that reaches the Italian market. An additional code has been added to the vignettes (bollinos) that have been used in Italy. The code contains a sequentially incremented number, which makes the substance unique in the valid period of use. The initiative on the part of the Italian government was a quick response to product traceability requirements imposed by the EU on pharmaceutical manufacturers. Other member states that use vignettes for traceability purposes are considering implementing these requirements.


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