The MINISTER Saw the art. 124 Royal Decree July 27, 1934, n. 1265, and subsequent amendments on "Approval of the consolidated text of the health laws"; Having regard to the Royal Decree of September 30, 1938, n. 1706 on "approval of the regulations for the pharmacy service"; Having regard to law no November 9, 1961. 1242 on "review and publication of official Pharmacopoeia"; Having regard to law October 22, 1973, n. 752 on "Ratification and implementation of the Convention for the elaboration of a European Pharmacopoeia, adopted in Strasbourg on July 22, 1964"; Having regard to act December 23, 1978, # 833, regarding "establishment of the national health service"; View the art. 26 April 24, 1998, law n. 128, containing "Provisions for the fulfilment of obligations arising from Italy's membership of the European Community"; Having regard to resolution AP-CPH (13) 3 March 21, 2013, adopted 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 European Pharmacopoeia 8.3 Supplement 8th Edition; Deemed it necessary to have the entry into force within the national territory of the texts adopted by the invoked resolution, as required 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 art. 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. The texts in English and French of the General chapters and monographs published in the European Pharmacopoeia 8.3 Supplement 8th Edition, 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 the subject of obligations under art. 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 art. 26 April 24, 1998, law 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.
Rome, January 20, 2015 the Minister: Lara