myHealthbox makes digital leaflets available for bilingual regions

THE MINISTER OF HEALTH

Given the art. 36 of the decree of the President of the Republic 15 July 1988, no. 574, containing «Implementation rules of the Statute special for the Trentino-Alto Adige Region on the use of German and Ladin language in relations with the public administration and in judicial proceedings» and following changes; Given the legislative decree 24 April 2006, n. 219 and, in in particular, the art. 80 which provides that at least the indications referred to articles 73, 77, 79 are written in Italian and, limited to medicines on the market in the Province of Bolzano, also in German. However, they must be compatible with the summary of product characteristics. The version of the leaflet in German may be made available to the purchaser in pharmacies and in the points of sale envisaged by art. 5 of the decree-law 4 July 2006, n. 223, converted, with amendments, by law 4 August 2006, n. 248, upon the sale of the medicinal product according to modalities to be established by decree of Minister of Health, also taking into account voluntary experiences already implemented on part of the national territory; Given the decree-law 4 July 2006, n. 223, converted, with amendments, by law 4 August 2006, n. 248; Having regard to the decree of the Minister of Health of 13 April 2007, containing «How to make available to the purchaser, at the time of sale, the German-language version of the product information leaflets medicinal products for human use", published in the Official Journal of the Italian Republic no. 96 of 26 April 2007 and, in particular, the art. 2 which provides that for the purposes of compliance with the provisions of the art. 80, paragraph 1 of the legislative decree 24 April 2006, n. 219, pharmaceutical companies can take advantage of the rendered methods available from Unifarm S.p.a. through its own database that collects, in electronic format, the leaflets updated in German language of medicinal products authorized for marketing in Italy and the color photographic reproductions of the relative packs in Italian; Given the note of 21 February 2019 with which the associations Assogenerici, Farmindustria and Federchimica have asked for one revision of the aforementioned ministerial decree of 13 April 2007, proposing «a modification of paragraph 1 of the art. 2, through an extension of the number of subjects to which pharmaceutical companies can turn in order to make the leaflets available in the language German in the Province of Bolzano»; Taking into account the results of the work carried out by the Technical Board of confrontation composed of representatives of the Ministry of Health, of Farmindustria, Assogenerici, Assosalute, Federfarma, Assofarm, Unifarm and the Autonomous Province of Bolzano; Given the presence on the market of other parties (with related databases), additional to Unifarm S.p.a., able to offer the service provided for by art. 80, paragraph 1 of the aforementioned legislative decree n. 219 of 2006, for the delivery of the sheet leaflet in German of the Autonomous Province of Bolzano, which currently the companies holders of A.I.C. they cater for the fulfilments pursuant to art. 37, paragraph 1-bis of the aforementioned decree legislative no. 219 of 2006, related to the obligation to return available in pharmacies and outlets that sell medicines to the public in accordance with current legislation throughout the territory national the updated version of the package leaflet, in case of modifications of the same;

Decrees:

Article 1

1. With the decree of the Minister of Health of 13 April 2007, cited in premise, the following changes have been made: a) in art. 2, after paragraph 1, the following is added: «1-bis. Pharmaceutical companies can still apply, for the same purposes and with the same methods referred to in paragraph 1, also to other service providers and related databases."; b) in art. 3, paragraph 1, the words: «to the database» are replaced by the following: «to the databases of the subjects referred to to art. 2" and the word: "named" is replaced by the following: "named"; c) in art. 4, paragraph 3, the word: «central» is deleted; d) in art. 5, paragraph 1, is replaced by the following: «1. The companies holding A.I.C. and the subjects referred to in art. 2 are responsible for the correct maintenance of the database e guarantee an adequate and constant degree of safety of the available information as well as the constant accessibility to it from part of all pharmacies and points of sale provided for by art. 5 of decree-law 4 July 2006, n. 223, converted, with modifications, by law 4 August 2006, n. 248, present in the Autonomous Province of Bolzano." This decree will be sent to the supervisory bodies for i provisions of competence and will be published in the Gazette Official of the Italian Republic. Rome, 29 July 2020

The Minister: Speranza