Source: https://www.global-regulation.com/translation/germany/384826/dye-regulation.html
Timestamp: 2018-08-15 21:20:35
Document Index: 616127768

Matched Legal Cases: ['§ 6', '§ 83', '§ 6', '§ 6', '§ 83', '§ 6', '§ 2', '§ 2', '§ 2', '§ 96', '§ 3']

Machine Translation of "Dye Regulation" (Germany)
Dye Regulation
Original Language Title: Arzneimittelfarbstoffverordnung
Read the untranslated law here: http://www.gesetze-im-internet.de/amfarbv_2005/BJNR303100005.html
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 (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.