The Italian Decree n. 219/2006 (implementing 2001/83/EC Directive and following amendments) establishes that at least the information reported in the labelling and in the package leaflet of medicinal products marketed in the Italian province of Bolzano must be available also in German language for the patients (Bilingualism requirement).
The German translation of the package leaflet and the labelling of the medicinal product, as authorized by the authority, must be sworn by an Italian Court, confirming its fidelity and accuracy.
To fulfil the bilingualism requirement, specialized providers offer a service dedicated to pharmaceutical companies. Such providers collect the German translations of the Italian authorized package leaflets and labelling, prepared according to a specific layout, in a dedicated database. The package leaflet and the labelling in German language will be then printed by pharmacists and delivered to patients, saving companies from additional repackaging costs.
Another way to meet this requirement that could be evaluated is using multilingual packaging including both Italian and German. This approach should be agreed with AIFA.
In peculiar cases, such as for example medicinal products not directly handled by patients, it is possible to request an exemption from the preparation of the German translation. This request must be submitted to AIFA for approval.
Regulatory Pharma Net provides full regulatory assistance during the whole product lifecycle and is ready to support companies on all regulatory needs, guiding them to meet all local requirements including bilingualism.