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Medicinal dye Regulation (AMFarbV) AMFarbV Ausfertigung date: 17.10.2005 full quotation: "medicinal dye regulation of 17 October 2005 (BGBl. I S. 3031), by article 8 of the law of 17 July 2009 (BGBl. I S. 1990) has been changed" stand: as amended by article 8 G v. 17.7.2009 I 1990 for more information on the stand number you find in the menu under instructions this regulation serves the - Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 establishing a Community code relating to veterinary medicinal products (OJ EC No. L 311, p. 1) - Directive 2001/83/EC of the European Parliament and of the Council of the 6 November 2001 on the Community code relating to medicinal products for human use (OJ EC No. L 311, p. 67).
Footnote (+++ text detection from: 27.10.2005 +++) (+++ official note of the standard authority on EC law: implementation of EGRL 82/2001 (CELEX Nr: 301 L 0082) EGRL 83/2001 (CELEX Nr: 301 L 0083) +++) input formula's Decree - the Federal Ministry of health and social security on the basis of § 6 para 1 sentence 1 and § 83 para 1 and 2 of the medicines act as amended by the notice of 11 December 1998 (BGBl. I S. 3586) , by § 6 para 1 last article 1 No. 4 letter a of the Act of 30 July 2004 (BGBl. I S. 2031) is been recast, the Federal Ministry for consumer protection, food and agriculture on the basis of § 6 para 1 sentence 1 in conjunction with sentence 2 and § 83 para 1 and 2 of the medicines act as amended by the notice of 11 December 1998 (BGBl. I S. 3586) , by § 6 para 1 last article 1 No. 4 letter a of the Act of 30 July 2004 (BGBl. I S. 2031) recast been is, in agreement with the Federal Ministry of health and social security: article 1 (1) in the production of drugs in the sense of § 2 para 1 of the medicines Act, which are intended, brought in a Member State of the European communities or in another Contracting State to the agreement on the European economic area on the market to be that may just those in annex I of to Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours used in food are allowed to the coloring (OJ EC No. L 237 p. 13), in its current version listed substances or preparations from these materials are used; These substances and their preparations have the purity criteria set out in the annex of to Directive 95/45/EC of 26 July 1995 laying down specific purity criteria for food coloring (OJ EC No. L 226, p. 1) in the currently valid version. If dyes in the monographs of the European Pharmacopoeia are described, they must in addition meet the requirements listed there.
(2) drugs in the sense of § 2 para 1 of the medicines Act, which are not manufactured in accordance with the provisions of paragraph 1 may be placed on the scope of the German medicines act not in the traffic.
§ 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 brings drugs violates article 1 para 2 in the traffic.
(2) in accordance with § 96, number 2 of the medicines Act will be punished who uses others violates article 1 para 1 in the manufacture of pharmaceutical products for staining as the listed substances or preparations from these materials.
(3) Whoever negligently commits an act referred to in paragraph 2, any person acts according to § 97 para. 1 of the German medicines Act.
§ 3 (1) enters into force on the day after the promulgation of this regulation.
(2) at the same time the dye regulation by August 25, 1982 (BGBl. I S. 1237), last amended by article 5 of the Act of 27 April 1993 (Federal Law Gazette I p. 512, 2436), override. Medicinal pursuant to sentence 1 in accordance with the regulation and services located on October 27, 2005 until November 1, 2006 may be placed by pharmaceutical companies and then by wholesalers and retailers in traffic.
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