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Regulation on the prohibition of the use of substances contaminated with aflatoxins in the manufacture of medicinal 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 on the prohibition of the use of substances contaminated with aflatoxins in the manufacture of medicinal products (aflatoxin prohibitions)

Unofficial table of contents

Aflatoxin VerbotsV

Date of completion: 19.07.2000

Full quote:

" Regulation prohibiting the use of substances contaminated with aflatoxins in the manufacture of medicinal products of 19 July 2000 (BGBl I). I p. 1081, 1505), as defined by Article 10 of the Law of 17 July 2009 (BGBl. 1990).

Status: Amended by Art. 10 G v. 17.7.2009 I 1990

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 1.2.2001 + + +) 
(+ + + Official note from the norm-provider on EC law:
Consideration of
ERL 34/98 (CELEX Nr: 398L0034) + + +)

The obligations laid down in Directive 98 /34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of the provisions relating to the services of The Information Society (OJ C EC No 37), as amended by Directive 98 /48/EC of the European Parliament and of the Council of 20 July 1998 (OJ L 136, 31.5.1998, p. EC No 18), have been observed. Unofficial table of contents

Input formula

The Federal Ministry of Health is responsible for the
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§ 6 (1) and (2) of the Medicinal Products Act as amended by the Notice of 11 December 1998 (BGBl. 3585), in agreement with the Federal Ministry of Food, Agriculture and Forestry;
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§ 54 (1) and (2) of the Medicinal Products Act, in conjunction with Article 56 of the Law on Jurisdiction Adaptation of 18 March 1975 (BGBl. 705) and the organisational decree of 27. October 1998 (BGBl. 3288), in agreement with the Federal Ministry of Economics and Technology and the Federal Ministry of Food, Agriculture and Forestry:
Unofficial table of contents

§ 1

(1) It is prohibited to use in the manufacture of medicinal products substances, preparations of substances or products in which the maximum amount of aflatoxin M1, calculated to be at least 88 per cent dry matter, of 0.05 micrograms per kilogram, Aflatoxin B1 of 2 micrograms per kilogram or the total amount of aflatoxins B1, B2, G1 and G2 of 4 micrograms per kilogram is exceeded. For enzymes and enzyme preparations, the first sentence shall apply, with the proviso that the total amount of aflatoxins B1, B2, G1 and G2 may not exceed 0.05 micrograms per kilogram. By way of derogation from the first sentence, the maximum permitted levels of aflatoxin shall apply to medicated feedingstuffs. (2) The placing on the market of a medicinal product which has been manufactured in accordance with the first sentence of paragraph 1 or 2 shall be prohibited. The provisions of feed law shall apply to feedingstuffs. (3) The determination of the aflatoxin content shall be based on sampling procedures which take into account any heterogeneous distribution of the aflatoxins, if any. Unofficial table of contents

§ 2

(1) According to Section 95 (1) No. 2, para. 2 to 4 of the German Medicines Act, the person who intentionally or negligently brings a medicinal product into circulation in accordance with § 1 (2) sentence 1 shall be punished. (2) According to § 96, point 2 of the German Medicines Act, it shall be punished who is against § 1 (1) sentence 1, also used in conjunction with sentence 2, substances, preparations of substances, products, enzymes or enzyme preparations. (3) Anyone who is negligent in committing an act referred to in paragraph 2 shall act in accordance with Section 97 (1) of the Medicinal Products Act Irregular. Unofficial table of contents

§ 3

This Regulation shall enter into force on the first day of the seventh calendar month following the proclamation. Unofficial table of contents

Final formula

The Federal Council has agreed.