Regulation On The Indication Of Medicinal Ingredients

Original Language Title: Verordnung über die Angabe von Arzneimittelbestandteilen

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Pharmaceutical ingredient specification

Non-official table of contents

AMBtAngV

Date of delivery: 04.10.1991

Full quote:

" Regulation on the indication of drug ingredients of 4. October 1991 (BGBl. I p. 1968) "

Footnote

(+ + + Text evidence from: 1. 1.1992 + + +) unofficial table of contents

input formula

On the basis of Section 12 (1a) of the Pharmaceutical Act of 24 June 2013, the German Medicines Act (CJC) August 1976 (BGBl. 2445, 2448), as defined by Article 1 (5) of the Law of 11. April 1990 (BGBl. 717), in conjunction with Article 56 (1) of the Jurisdiction Adaptation Act of 18 June 1991. March 1975 (BGBl. 705) and the organisation of the Federal Chancellor ' s organisation of 23. January 1991 (BGBl. I p. 530), the Federal Minister for Health, in agreement with the Federal Minister for Food, Agriculture and Forestry,: Table of contents

§ 1

(1) The substances or preparations of substances mentioned in the Appendix are not subject to the obligation to claim in accordance with § 11 (1) sentence 1 (3) and § 11a (1) sentence 2 no. 3 of the Medicines Act, insofar as it is are not active ingredients and are used in medicinal products of the respective fields of application mentioned in the Appendix.(2) Where odour or flavouring substances are used in medicinal products in the fields of application referred to in points 1.1 or 2 of the Appendix, they may be indicated by the summary name of "odorous substances" or "flavouring substances". If they contain bergamot oil, beta-asarone or safrol, they shall be indicated.(3) If dyes are used, they may be indicated by the name "dye" or "colouring matter", followed by the EEC number or the EEC number.(4) If alkyl-4-hydroxybenzoates are used as preservatives, they may be given as 'paraben' or 'parabens', followed by the EEC number or the EEC number. This shall apply only to medicinal products in the fields of application referred to in points 1.1 and 2 of the Appendix. Non-official table of contents

§ 2

This regulation occurs on the 1. January 1992 in force. Non-official table of contents

Final formula

The Federal Council has agreed. Nontam_TOC

Asset

1
pH adjustment or buffering fabrics
1.1
in medicines for use on the skin, and Mucosa, including the vaginal mucosa, with the exception of the medicinal products for use in the eye: malic acid and its citric acid and its sodium salt and its magnesium, sodium and sodium salts. Potassium salt 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 salt sulphuric acid and its sodium, potassium and potassium salts. magnesium salzewater tartaric acid
1.2
in medicinal products for use in the eye: acetic acid and its sodium and potassium salt potassium hydroxide sodium carbonate sodium bicarbonate sodium hydroxide hydrochloric acid water
2
substances in oral medicines: malic acid and its Salcesuccinic acid cellulose citric acid and its sodium salt printing inks and their constituent acetic acid and their magnesium, sodium and potassium salzefats, natural gelatine potassium hydroxide maleic acid mono-and disaccharides, degradable, excluding Lactose, as well as sorbitol and xylitol if the daily dose of the finished product for adults does not give more than 3 g and not more than 2 g for children of lactic acid and sodium bicarbonate of sodium bicarbonate sodium hydroxide, sodium carbonate, natural hydrochloric acid and its sodium, potassium, magnesium and calcium salessulphuric acid and its sodium and potassium salt-silica starch hydro-tartaric acid
3
substances in Vaccines in physiologically insignificant amounts: amino acids and peptides, purines and pyrimidineelectrolytemono-and disaccharides, biodegradable vitamins and their pre-productsWater sugar alcohols (dulcite, inositol, mannitol, sorbitol)