Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-19&atto.codiceRedazionale=15A01906&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved February 23, 2015 OMEGOIL # 181/2015 determines the medication: Mah: Altergon Italy S.r.l.
Via dell'industria 83030 Pietradefusi (AV) Italy Package "1000 mg soft capsules" 20 capsules in blister PVC/PVDC/AIC # 040711095 (10) 16UDXR (based on 32) dosage form: soft capsules composition: each soft capsule contains: active ingredient: ethyl esters of 1000 mg of omega-3 to 90% classification for the purposes of new listings is the packs referred to in art. 1 are placed, by virtue of art. 12, paragraph 5, of Decree-Law No September 13, 2012. 158, converted, with amendments, by law November 8, 2012, n. 189, in the section dedicated to drugs not yet evaluated for the purposes of new listings, the class of article. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, called class C (nn).
Classification for the purpose of the classification for the supply of the medicinal product OMEGOIL is as follows: medicinal product subject to medical prescription (RR) printed packets of medicine must be placed on the market with handouts, as previously approved by this administration, with the only changes necessary to adapt to this determination.
In accordance with art. 80 paragraphs 1 and 3 of the Legislative Decree of April 24, 2006, # 219 s and the package 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.
Date of determination: from the day following its publication in the official journal of the Italian Republic.
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