Regulation On The Prohibition Of The Use Of Substances Contaminated With Aflatoxins In The Manufacture Of Pharmaceutical Products

Original Language Title: Verordnung über das Verbot der Verwendung von mit Aflatoxinen kontaminierten Stoffen bei der Herstellung von Arzneimitteln

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Regulation prohibiting the use of with aflatoxin contaminated substances in the manufacture of pharmaceutical products (aflatoxin VerbotsV) aflatoxin VerbotsV Ausfertigung date: 19.07.2000 full quotation: "regulation on the prohibition of the use of substances contaminated with aflatoxins in the production of pharmaceutical products by 19 July 2000 (BGBl. I S. 1081, 1505), by article 10 of the law of 17 July 2009 (BGBl. I S. 1990) has been changed" stand : Amended by art. 10 G v. 17.7.2009 I 1990 for more information on the stand number you see in the menu see remarks footnote (+++ text detection from: 1.2.2001 +++) (+++ official note of the standard authority on EC law: consideration of EGRL of 98 at the 34 (CELEX Nr: 398 L 0034) +++) the obligations under Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 establishing an information procedure in the field of technical standards and regulations and of the rules for the services of the information society (OJ EC No. L 204, p. 37), as amended by Directive 98/48/EC of the European Parliament and of the Council of 20 July 1998 (OJ EC No. L 217, p. 18), have been observed.

Input formula prescribed aground - § 6 para 1 and 2 of the medicines act as amended by the notice of 11 December 1998 the Federal Ministry for health (Federal Law Gazette I p. 3585) in agreement with the Federal Ministry of food, agriculture and forestry;
-§ 54 para 1 and 2 of the medicines Act in conjunction with article 56 of the Zuständigkeitsanpassungs law of 18 March 1975 (Federal Law Gazette I p. 705) and the Organization Decree of 27 October 1998 (BGBl. I S. 3288) in agreement with the Federal Ministry of Economics and technology and the Federal Ministry of food, agriculture and forestry: § 1 (1) it is prohibited in the manufacture of medicinal substances , Preparations of substances or products to use, where the calculated maximum amount of aflatoxin M1 of 0.05 micrograms per kilogram of aflatoxin B1 of 2 micrograms per kilogram or the total amount of aflatoxins B1, B2, G1 and G2 of 4 micrograms per kilogram exceeded dry matter at least 88 per cent. Sentence 1 with the proviso that the total amount of aflatoxins B1, B2, G1 and G2 may not exceed 0.05 micrograms per kilogram applies to enzymes and enzyme preparations. By way of derogation from sentence 1 the feed law laid down maximum levels of aflatoxin are for medicated feedingstuffs.
(2) the placing on the market of a medicinal product, which set 1 or 2 has been established contrary to paragraph 1, is prohibited. The food law regulations for medicated feedingstuffs.
(3) in determining the Aflatoxingehaltes be sampling procedures for reason to lay, which take into account a possibly existing heterogeneous distribution of aflatoxins are.

Section 2 (1) according to article 95, paragraph 1 No. 2, paras 2 to 4 of the medicines Act will be punished who intentionally or negligently makes a medicinal product on the market contrary to section 1, paragraph 2, sentence 1.
(2) in accordance with article 96 paragraph 2 of the German medicines Act will be punished, who used contrary to § 1 para 1 sentence 1, also in conjunction with sentence 2, substances, preparations of substances, products, enzymes or enzyme preparations.
(3) Whoever negligently commits an act referred to in paragraph 2, any person acts according to § 97 para. 1 of the German medicines Act.

Article 3 this regulation enters into force on the first day of the seventh calendar month following on the announcement.

Concluding formula the Federal Council has approved.