Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-20&atto.codiceRedazionale=15A00306&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved V&A 2655/2014 December 16, 2014 # the determines (authorization of changes concerning the medicine Bettamousse) are authorized the following variation: 1 module Update in anticipation of a RUP (Repeat Use procedures) with Risk Management System and Environmental Risk Assessment in relation to medicine, BETTAMOUSSE in shapes and packagings listed below: 034226011-large recipient. Under Press. 100 G 50 G 034226023 Cutaneous Foam-Skin Foam pressurized container handouts corrected and approved shall be annexed to the assessment.
How to: UK/H/0240/001/II/022 type of variation: c. 1) other variation Mah: SANDOZ S.P. to Print 1. The marketing authorisation holder should make the changes, after the date of entry into force of this Determination to the summary of product characteristics; no later than six months from the same date the package leaflet and labelling.
2. In accordance with art. 80, paragraphs 1 and 3, of Legislative Decree No 219 April 24, 2006 and s, leaflet and labels must be written in Italian and, limited to medicinal products marketed in the province of Bolzano, in German. The mAh avails itself of the complementary use of foreign languages, must give prior notice to the AIFA and keep available the certified translation of German texts and/or in another foreign language. In case of non-compliance with the provisions on the labelling and package leaflet shall apply sanctions under art. 82 of the aforementioned legislative decree.
Inventory disposal 1. Both lots already products on the date of entry into force of this determination that the batches produced during the period referred to in article 2, paragraph 1, of the present, not bearing approved changes can be kept on the market until the expiration date printed on the label of the medicine. Pharmacists are required to deliver the package leaflet updated users, as from the end of 30 days from the date of publication in the Official Gazette of the Italian Republic of this determination. The Mah makes accessible to pharmacist leaflet updated within the same timeframe.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica Italiana.
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