Regulation on the indication of the components of medicinal products

Unofficial table of contents

AMBtAngV

Date of completion: 04.10.1991

Full quote:

" Regulation on the indication of the components of medicinal products 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 Medicines Act of 24 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 Adjustment Act of 18 March 1975 (BGBl). 705) and the organisation of the Federal Chancellor ' s organisation of 23 January 1991 (BGBl. 530), the Federal Minister of Health, in agreement with the Federal Minister for Food, Agriculture and Forestry, is responsible for: Unofficial table of contents

§ 1

(1) The substances or preparations of substances referred to in the Appendix are not subject to the obligation to claim in accordance with § 11 (1) sentence 1 (3) and § 11a (1) sentence 2 (3) of the Medicines Act, unless they are effective ingredients). and are used in medicinal products for the fields of application mentioned in the Annex. (2) Use of odour or flavouring substances in medicinal products in the fields of application referred to in points 1.1 or 2 in the Appendix, these may be indicated by the summary name of "odorous substances" or "flavouring substances" . If they contain bergamot oil, beta-asarone or safrol, they must be indicated. (3) If colours are used, they may be indicated by the name 'dye' or 'colouring', followed by the EEC number or the EEC number. Alkyl-4-hydroxybenzoates used as preservatives may be indicated by the term "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. Unofficial table of contents

§ 2

This Regulation shall enter into force on 1 January 1992. Unofficial table of contents

Final formula

The Federal Council has agreed. Unofficial table of contents

Annex

1

Substances for pH adjustment or buffering

1.1

in medicinal products 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 salceacetic acid and its sodium and its salessuccinic acid and its sodium salt Magnesium, sodium and potassium salts, potassium hydroxide, lactic acid and sodium bicarbonate sodium bicarbonate, sodium hydroxide, sodium, potassium, magnesium and calcium salts, and their 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 hydroxide sodium hydroxide sodium bicarbonate sodium hydroxide/hydrochloric acid water

2

Substances in orally administered medicinal products: malic acid and its salessuccinic acid cellulose citric acid and its sodium salt printing inks and its constituent acetic acid and its magnesium, sodium and potassium salesfats, natural gelatine potassium hydroxide mono-and disaccharides, degradable, excluding lactose, as well as sorbitol and xylitol if the daily dose of the ready-to-use medicinal product does not give more than 3 g for adults and no more than 2 g for children Lactic acid and sodium bicarbonate of sodium bicarbonate of sodium hydroxide, natural hydrochloric acid and its sodium, potassium, magnesium and calcium salessulphuric acid and its sodium and potassium salt-silicon dioxide 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 preproduction water sugar alcohols (dulcite, inositol, mannitol, sorbitol)