Rita Gemini -

According to the Italian Decree n. 219/2006 (implementing 2001/83/EC Directive and following amendments), at least the information reported in the labelling and the package leaflet of medicinal products marketed in the Italian province of Bolzano should be available for the patients also in German language.

The above mentioned information in German language can be made available to the patients at pharmacies and at sales points.

In order to fulfill the “bilingualism” requirement (Italian and German), pharmaceutical companies make use of the service provided by Unifarm Spa, through the subscription of a service agreement, according to the Ministry of Health Decree dated April 13th, 2007.

Unifarm Spa collects the German translations of the Italian authorized package leaflets and labelling, prepared according to a specific layout, in a dedicated database and allows pharmacists to print them for the patients who require them.

Should the above-mentioned dispositions be not fulfilled, the Italian Agency, with justified action, will require the MAH to fulfill the obligation establishing a deadline. In the case of noncompliance within the deadline, the Italian Agency can suspend the Marketing Authorisation of the medicinal product until the MAH takes adequate action to be compliant with the law.

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