Medicinal product warning system (AMWarnV)

Unofficial table of contents

AMWarnV

Date of completion: 21.12.1984

Full quote:

" Medicines Warning Ordinance of 21 December 1984 (BGBl. 1985 I p. 22) "

Footnote

(+ + + Text certificate from: 1. 4.1985 + + +)
(+ + + Changes due to EinigVtr cf. § 6 + + +)
(+ + + Stand: EinigVtr v. 31. 8.1990 iVm Art. 1 G v. 23. 9.1990 + + +)

-BGBl. II 1990, 885, 1085

Unofficial table of contents

Input formula

Pursuant to Section 12 (1) (1) and (3) of the Medicinal Products Act of 24 August 1976 (BGBl). I p. 2445, 2448) is decreed in agreement with the Federal Minister for Economic Affairs with the approval of the Federal Council: Unofficial table of contents

§ 1 Scope of application, extension of provisions of the Medicines Act

(1) This Regulation shall apply to medicinal products within the meaning of Article 2 (1) or (2) (1) of the Medicinal Products Act, which are intended to be placed on the market in a pack intended for delivery to the consumer and which are intended to:

1.

Ethanol and are intended for internal use in human beings, provided that:

a)

liquid preparations for oral administration and the amount of ethanol in the maximum individual dose after the dosage is at least 0.05 g; or

b)

Solutions for injection, infusion solutions, mouth disinfectants or revenge disinfectants, and the ethanol content in the maximum dose after the dosing instructions is at least 0.05 g or

2.

Tartrazine contain and are intended for use in humans.

§ 10 (1) and (2) and § 11 (1) and (2) of the Medicinal Products Act shall apply to the extent to which they relate to the indication of the warning prescribed in accordance with this Regulation, including for medicinal products as defined in the first sentence, which are not manufactured medicinal products. (2) This Regulation is not to be applied to medicinal products intended for clinical testing. Unofficial table of contents

§ 2 Warning on the containers and outer envelopes

(1) Medicinal products as defined in section 1 (1), first sentence, point 1 (a) may only be placed on the market if the following warnings are attached stating the volume percentage content of ethanol:

1.

In the case of medicinal products containing 0.05 g to 0.5 g of ethanol in the maximum individual dose after the dosage, " Contains ... Vol.% alcohol. " and

2.

in the case of medicinal products containing more than 0.5 g of ethanol in the maximum individual dose after the dosage, " Contains ... Vol.% alcohol; read the package leaflet before use! ".

(2) Medicinal products as defined in section 1 (1), first sentence, point 1 (b) may only be placed on the market if the volume percentage of ethanol is indicated in the warning "Contains ... vol.-% alcohol." (3) Medicinal products as defined in § 1 para. 1 sentence 1 No 2 may be placed on the market only if the warning "Contains tartrazine; note the package leaflet" is appropriate. (4) The warnings must be placed on the containers and outer envelopes in easy-to-read writing and on permanent By way of example. Unofficial table of contents

§ 3 Warning on the package leaflet

(1) Medicinal products as defined in section 1 (1), first sentence, point 1 (a) may be placed on the market only if a warning is affixed to the package leaflet in a readily legible document, indicating the volume percentage of ethanol

1.

in the case of medicinal products containing 0.05 g to 0.5 g of ethanol in the maximum individual dose after the dosage of the dose, the following wording: " Contains ... Vol.% alcohol. ",

2.

in the case of medicinal products containing more than 0.5 g to 3.0 g of ethanol in the maximum individual dose following the dosage instructions, the following wording: " Warning: This medicinal product shall contain ... Vol.% alcohol. If the dosage instructions are observed, up to ... g alcohol will be supplied each time you take the dose. There is a health risk. a. in the case of liver diseases, alcohol sufferers, epileptics, brain damaged patients, pregnant women and children. The effect of other medicinal products may be impaired or strengthened. " and

3.

in the case of medicinal products containing more than 3.0 g of ethanol in the maximum individual dose following the dosing instructions, the following wording: " Warning: This medicinal product contains ... Vol.% alcohol. If the dosage instructions are observed, up to ... g alcohol will be supplied each time you take the dose. Caution is required. This medicinal product should not be used in liver disease, alcohol, epilepsy, brain injury, pregnant women and children. The effect of other medicinal products may be impaired or strengthened. In road transport and in the operation of machines, the reaction capacity can be impaired. "

In the warnings referred to in the first sentence of the first sentence of 1 and 3, the number of teaspoons, spoons, measuring spoons, measuring cups or any other quantity indicated in the dosing instructions shall be given in parentheses after the word 'intake'. (2) Medicinal products referred to in Article 1 (1), first sentence, point 1 (b) may be placed on the market only if a warning is affixed to the package leaflet in an easy-to-read document, indicating the volume percentage of ethanol following the following: Wording has:
"Contains ... volume-% alcohol". (3) Medicines according to § 1 para. 1 sentence 1 sentence 2 may only be placed on the market if a warning is affixed to the package leaflet in easy-to-read writing, which reads as follows:
" Warning
This medicinal product contains tartrazine, which can cause allergic reactions to persons who are particularly sensitive to this substance. ' (4) Paragraphs 1 to 3 shall apply to medicinal products which:

1.

be made on a specific request or order in individual cases,

2.

be placed on the market without a package leaflet in accordance with Article 3 (11) (2) of the Law on the Reorganisation of the Right of Medicinal Products,

only if the prescribed warning is different from the warning referred to in § 2 and provided that the warning referred to in paragraphs 1, 2 or 3 must be attached to the container or attached to the container in a readily legible document. Unofficial table of contents

§ 3a Warning on the subject information

The warning notice prescribed in accordance with § 3 (1), (2) or (3) shall also be indicated on the subject information. Unofficial table of contents

§ 4 Administrative Offences

Who intentionally or negligently

1.

Contrary to § 2 of the German Medicines Act (medicinal product) without the prescribed warning on the market, the provisions of Section 97 (2) (4) of the Medicines Act act in an orderly manner

2.

Contrary to § 3 para. 1, 2 or 3 medicinal products without the prescribed warning to the traffic, acts in accordance with § 97 para. 2 no. 5 of the Medicines Act.

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§ 5 Berlin clause

This Regulation applies in accordance with Section 14 of the Third Transfer Act, in conjunction with Section 99 of the German Medicines Act, also in the Land of Berlin. Unofficial table of contents

§ 6 Entry into force

(1) This Regulation shall enter into force on 1 April 1985. (2) Medicinal products which are on the market on 1 April 1985 may still be marketed by the pharmaceutical company until 31 December 1985 and by wholesalers and retailers until 31 December 1986. without the mandatory warnings or with the warnings which have been ordered by the competent federal authority pursuant to § 28 of the Medicines Act before the entry into force of the regulation, be placed on the market. (3) Medicinal products which do not comply with the provisions of § § 1 to 3a and which become effective when the product is active Whereas accession to the territory referred to in Article 3 of the Agreement on Transport may be placed on the market by pharmaceutical undertakings until 31 December 1991 and thereafter by wholesalers and retailers, provided that: comply with the relevant provisions of the German Democratic Republic before the date of entry into force of the accession. Unofficial table of contents

Final formula

The Federal Minister for Youth, Family and Health