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Regulation on the indication of medicinal ingredients AMBtAngV Ausfertigung date: 04.10.1991 full quotation: "regulation on the indication of medicinal ingredients of 4 October 1991 (BGBl. I S. 1968)" footnote (+++ text detection from: 1 1.1992 +++) input formula on the basis of § 12 of the paragraph 1a of the German medicines Act of 24 August 1976 (Federal Law Gazette I p. 2445, 2448), by article 1 No. 5 of the law of 11 April 1990 (BGBl. I S. 717) is been inserted , in conjunction with article 56 para 1 of the Zuständigkeitsanpassungs law of 18 March 1975 (BGBl. I p. 705) and the Organization adopting of the Chancellor of 23 January 1991 (BGBl. I p. 530) enacted the Federal Minister of health in consultation with the Federal Minister for food, agriculture and forestry: § 1 (1) the substances listed in the annex or preparations of substances are not the obligation to indicate to section 11, subsection 1, sentence 1 No. 3 and § 11a paragraph 1 sentence 2 No. 3 of the Medicines Act, insofar as it is not effective components and they are used in medicines of applications each indicated in the annex.
(2) fragrance or flavouring used 1.1 or 2 mentioned application areas in pharmaceutical products in the in the system under the numbers, so these may be specified with the summary term "Odorous" or "Flavours". They contain bergamot oil, beta-Asarone, or safrole, this should be to specify.
(3) be used dyes, this must be indicated followed with the designation "Dye" or "Coloring", by the EEC number or the EC numbers.
(4) alkyl-4-hydroxybenzoate are used as preservatives, these may be indicated followed with the designation "Paraben" or "Parabens", by the EEC number or the EC numbers. This applies only to medicines in the in the system under paragraphs 1.1 and 2 mentioned application areas.
Article 2 this regulation enters into force on 1 January 1992.
Concluding formula the Federal Council has approved.
Appendix 1 substances for pH-adjustment or buffering 1.1 in medicines used on the skin and mucous membranes including the vaginal mucous membrane, with the exception of pharmaceutical products to be applied to the eye: Malic acid and their salts of Succinic acid citric acid and its sodium salts acetic acid and its magnesium, sodium and potassium salts potassium hydroxide maleic acid lactic acid and its sodium salt sodium carbonate sodium bicarbonate sodium hydroxide hydrochloric acid and its sodium, potassium, magnesium and calcium salts sulphuric acid and its sodium , Potassium and magnesium salts water tartaric acid 1.2 in pharmaceutical products to be applied to the eye: acetic acid and its sodium and potassium salts potassium hydroxide sodium carbonate sodium bicarbonate sodium hydroxide hydrochloric acid water 2 substances in to apply oral medicines: Malic acid and their salts of Succinic acid cellulose, citric acid and its sodium salts of printing inks and their components acetic acid and its magnesium, sodium and potassium salts fats, natural gelatin potassium hydroxide maleic acid Mono and disaccharides, biodegradable, excluding lactose , as well as sorbitol and xylitol, when with the daily dose of the finished medicinal product for adults no more than 3 g and for children administered not more than 2 g of lactic acid and its sodium salt sodium carbonate sodium bicarbonate are oils, natural hydrochloric acid and its sodium, potassium, magnesium and calcium salts sodium hydroxide sulfuric acid and its sodium and potassium salts silicon dioxide thickness water tartaric acid 3 substances in vaccines in physiologically insignificant amounts : Amino acids and peptides, purine and pyrimidine electrolytes Mono - and disaccharides, biodegradable vitamins and their precursors water sugar alcohols (Dulcite, inositol, mannitol, sorbitol)
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