Article 14 of Legislative Decree 29th May 2001, no. 283 (Regulations on the implementation of the Special Constitution of the Region Trentino Alto Adige regarding the obligation of bilingualism in the preparation of labels and patient information leaflets of medicines) provides for that labels and PILs of medicines marketed in the Italian Region Trentino Alto Adige are supplied also in German and are made available to pharmacists through the database Unifarm.
In order to comply with this regulation, Di Renzo Regulatory Affairs has increased its relevant unit – now consisting of a mother-tongue translator, a graphic designer and an expert on data entry – to translate labels and PILs into German in a short time and at competitive prices, including legalization by an Italian court, lay out in the format required by Unifarm and database entry.