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The regulation on bilingualism and the Unifarm database

Art. 14 of Legislative Decree of 9 May 2001, no. 283 (Implementing regulations of the Special Statute of the Region Trentino Alto Adige, regarding the obligation of bilingualism in the drafting of labels and information leaflets of medicinal products) provides for that labels and package information leaflets of medicines marketed in the Italian region Trentino Alto Adige are also supplied in German and made available to pharmacists via the database Unifarm and other dedicated databases.

Di Renzo Regulatory Affairs has a special unit dedicated to this area of expertise, composed by a native speaker translator, a graphics designer and a data entry professional. We can carry out the following activities:

  • Preparation of the translation of package information leaflets and labelling into German
  • Legalisation of the texts and their relevant translations by an Italian Court
  • Layout according to the format required by Unifarm and other databases followed by its upload.