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 substances contaminated with aflatoxins in the manufacture of pharmaceutical products (aflatoxin prohibitions)

Non-official table of contents

aflatoxin VerbotsV

Date of expiry: 19.07.2000

Full quote:

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

:Modified by Art. 10 G v. 17.7.2009 I 1990

See Notes

Footnote

(+ + + Text evidence: 1.2.2001 + + +)
(+ + + Amcial) for details on the stand. Note from the norm provider to EC law:
compliance with the
EGRL 34/98 (CELEX Nr: 398L0034) + + +)

The obligations arising from Directive 98 /34/EC of the European Parliament and of the Council of 22 June 1998 on the European Parliament and of the Council of the European Communities. The European Parliament and of the Council of 19 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of the rules on information society services (OJ C EC No 37), as amended by Directive 98 /48/EC of the European Parliament and of the Council of 20 June 2000, of the European Parliament and of the Council of 20 June 1 July 1998 (OJ L 327, EC No 18), have been observed. Non-official table of contents

Inbox formula

The Federal Ministry of Health is responsible for the reason
-
of § 6 para. 1 and 2 of the Medicines Act, as amended by the 11. December 1998 (BGBl. 3585), in agreement with the Federal Ministry of Food, Agriculture and Forestry;
-
Section 54 (1) and (2) of the Medicines Act in conjunction with Article 56 of the Jurisdiction Adjustment Act 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 forbidden to use substances or preparations from substances or products in the manufacture of medicinal products in which the substances are at least 88% Percent dry mass calculated maximum amount of aflatoxin M1 of 0.05 micrograms per kilogram, on aflatoxin B1 of 2 micrograms per kilogram, or the total amount of aflatoxins B1, B2, G1 and G2 of 4 micrograms per kilogram. 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, for medicated feedingstuffs, the maximum levels of aflatoxin which have been laid down in terms of feed shall be laid down.(2) The placing on the market of a medicinal product which has been manufactured in accordance with the first sentence of the first or second sentence of paragraph 1 shall be prohibited. The provisions of feed law shall apply to medicated feedingstuffs.(3) The determination of the aflatoxin content should be based on sampling methods which take into account any heterogeneous distribution of the aflatoxins which may be present. Non-official table of contents

§ 2

(1) According to § 95, para. 1, no. 2, para. 2 to 4 of the Medicines Act, it is punished who intentionally or negligently in accordance with § 1 (2) sentence 1, placing a medicinal product on the market.(2) In accordance with Section 96 (2) of the Medicinal Products Act, it is punishable who uses substances, products, enzymes or enzyme preparations in connection with sentence 2, substances, preparations of substances, products, enzymes or enzyme preparations, in accordance with the first sentence of Article 1 (1).(3) Anyone who is negligent in committing an act referred to in paragraph 2 shall act in an orderly way in accordance with Section 97 (1) of the Medicinal Products Act. Non-official table of contents

§ 3

This Regulation shall enter into force on the first day of the seventh calendar month following the announcement. Non-official table of contents

Final formula

The Bundesrat has agreed.