Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-04-30&atto.codiceRedazionale=15A03133&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
HEALTH MINISTER having regard to article 124 Royal Decree July 27, 1934, n. 1265, as amended, laying down ' Approval of the consolidated text of the health laws '; Having regard to the Royal Decree of September 30, 1938, n. 1706 laying ' approval of the regulations for the pharmaceutical service '; Having regard to law no November 9, 1961. 1242 laying ' review and publication of official Pharmacopoeia; Having regard to law October 22, 1973, n. Ratification and implementation of the 752 laying, «Convention for the elaboration of a European Pharmacopoeia, adopted in Strasbourg on July 22, 1964 '; Having regard to act December 23, 1978, # 833, bearing ' NHS Institution '; Having regard to article 26 of the law April 24, 1998, n. 128, containing "provisions for the fulfilment of the obligations arising from Italy's membership of the European Communities '; Having regard to resolution AP-CPH (14) 5, adopted on December 12, 2014 by the Council of Europe, European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH), with which it was determined the entry into force from 1 January 2015 the corrected text of the monograph human Antithrombin III concentrate (0878) of the European Pharmacopoeia; Deemed it necessary to have the entry into force within the national territory of the text adopted by resolution callback, as foreseen by art. 26 of law no 128 of 1998, and to clarify that the texts in English and French under this Decree shall be excluded from the scope of the provision contained in article 123, first subparagraph, point b), of the consolidated text of the health laws approved by Royal Decree July 27, 1934, n. 1265;
Decrees: Art. 1 1. Corrected texts in English and French of the monograph human Antithrombin III concentrate (0878) of the European Pharmacopoeia, listed in the annex to this Decree shall enter into force within the national territory, as part of the Italian official Pharmacopoeia, from 1 January 2015. 2. the texts in English and French recalled in paragraph 1 are not object of the obligations under article 123, paragraph 1, point b), of the Royal Decree of July 27, 1934, n. 1265, bearing the only text of the health laws. The same texts, pursuant to article 26 of the law April 24, 1998, n. 128, are available to any interested party for consultation and clarification at the technical secretariat of the Standing Committee for review and publication of official pharmacopoeia Act November 9, 1961, # 1242. This Decree will be published in the official journal of the Italian Republic.
Roma, March 26, 2015 the Minister: Lara
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