Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-21&atto.codiceRedazionale=15A02066&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved February 25, 2015 V&A # 371/2015 determines the authorized the following variation: Add the batch size of 300 L at 25 ml fill volume packs.
In relation to the medicinal product and authorisation authorised pack sizes in Italy following the mutual recognition procedure.
Types of variation: b. II b. 4 Mah: Accord Healthcare Italy S.r.l.
Inventory disposal lots already products can be kept on the market until the expiration date printed on the label of the medicinal product in accordance with art. 1 paragraph 5 of the AIFA 14/04/2014 # 371 of Determines published in the Official Gazette No. 101 of 03/05/2014.
Date of determination: this determination is effective on the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica Italiana and company will be notified to the holder of the marketing authorisation for the medicinal product.
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