Drug Warning Notice Regulation

Original Language Title: Arzneimittel-Warnhinweisverordnung

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$20 per month, or Get a Day Pass for only USD$4.99.

Medicines Warning Regulation (AMWarnV)

Non-official table of contents

AMWarnV

Date of delivery: 21.12.1984

Full quote:

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

footnote

(+ + + text evidence 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

Based on § 12 (1) (1) and (3) of the Medicines Act 24. August 1976 (BGBl. I p. 2445, 2448) is, in agreement with the Federal Minister for Economic Affairs, with the approval of the Federal Council: Non-official table of contents

§ 1 Scope, extension of the provisions of the German Medicines

(1) This Regulation shall apply to medicinal products within the meaning of Section 2 (1) or (2) (1) of the Medicinal Products Act, which are intended to be used in a medicinal product for the purpose of giving effect to the to be placed on the market for the consumer and the
1.
ethanol and the internal use in humans, provided that they are
a)
oral preparations for oral use and the ethanol content in the maximum single dose after the dosage is at least 0.05 g or
b)
Injection solutions, infusion solutions, Mouth disinfectant or revenge disinfectant, and the ethanol content in the maximum individual dose after the dosing instructions is at least 0.05 g
2.
Tartrazine included and intended for use in humans.
§ 10 (1) and (2) and § 11 (1) and (2) of the Medicines Act shall apply to the extent to which they are indicated in accordance with this In the case of medicinal products as referred to in the first sentence of this Regulation, which are not ready for use in the manufacture of finished medicinal products.(2) This Regulation shall not apply to medicinal products intended for clinical trials. Non-official table of contents

§ 2 Warning message on containers and outer envelopes

(1) Medicinal products in accordance with § 1 (1), first sentence, point 1 (a) may be placed on the market only if the volume percentage content of ethanol is indicated in the following warnings:
1.
In the case of medicines containing 0.05 g to 0.5 g of ethanol in the maximum individual dose after the dosing instructions, " Contains ... Vol.% alcohol. " and
2.
for medicinal products containing more than 0.5 g of ethanol in the maximum individual dose after the dosage, " contains ...
() Medicinal products according to § 1 (1) sentence 1 (1) (b) may only be placed on the market if the volume percentage of ethanol in the warning contains the warning " Contains ... Vol.% alcohol. " is appropriate.(3) Medicinal products as defined in Section 1 (1), first sentence, No. 2 may only be placed on the market if the warning "Contains tartrazine; see the package leaflet before use!" is appropriate.(4) The warnings must be placed on the containers and outer envelopes in easy-to-read lettering and in a durable manner. A non-official table of contents

§ 3 Warning on the package leaflet

(1) Medicinal products as defined in § 1 (1) sentence 1 (1) (a) may only be used in the If a warning is affixed to the package leaflet in an easy-to-read font, the information indicating the volume percentage of ethanol
1.
for medicines containing 0.05 g to 0.5 g of ethanol in the maximum individual dose after dosing instructions, the following wording has been: " Contains ... Vol.% alcohol. ',
2.
for medicinal products containing more than 0.5 g to 3.0 g of ethanol in the maximum individual dose after the dose line, the following wording: hat: " Warnings of this medicinal product contains ... Vol.% alcohol. In case of compliance with the dosing instructions, each time you take up to ... g alcohol. There is a health risk. a. in the case of liver patients, alcohol sufferers, epileptics, brain damaged patients, pregnant women and children. The effect of other medicinal products may be impaired or strengthened. "and
3.
for medicinal products containing more than 3.0 g of ethanol in the maximum individual dose after the dosing instructions: " Warning of this medicinal product contains ... Vol.% alcohol. In case of compliance with the dosing instructions, each time you take up to ... g alcohol. 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 the case of road transport and in the operation of machinery, the reaction capacity may be affected. "
In the warnings referred to in the first sentence of sentence 1 (2) and (3), the number of teaspoons indicated for the intake, the spoon, is indicated after the word" intake ". Measuring spoons, measuring cups or any other quantity indicated in the dosing instructions shall be indicated in brackets.(2) Medicinal products as defined 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 a readily legible document, indicating the volume percentage of ethanol following Wording has:
" Contains ... (3) Medicinal products as defined in § 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 message
This Medicinal products contain tartrazine, which can cause allergic reactions in persons who are particularly sensitive to this substance ". (4) Paragraphs 1 to 3 shall apply to medicinal products which have been given a style="font-weight:normal; font-style:normal; text-decoration:none; ">
1.
on a case-by-case basis, on special request or order,
2.
pursuant to Article 3 (11) (2) of the Law on the Reorder of the Right of Medicinal Products without the Package Leaflet to be placed on the market,
only if the prescribed warning is shall be different from the warning referred to in Article 2, and with the proviso that the warning referred to in paragraphs 1, 2 or 3 shall be attached to or affixed to the container in a readily legible document. Non-official table of contents

§ 3a Warning information on the subject information

The warning notice prescribed in accordance with § 3 (1), (2) or (3) is also available on the Indicate subject information. Non-official table of contents

§ 4 Administrative Offences

Who intentionally or negligently
1.
contrary to § 2 medicinal products without the mandatory warning message, is acting in accordance with § 97
article 3 (
) of the Medicines Act, contrary to3 para. 1, 2 or
of the Medicinal Products Act, without placing the prescribed warning on the market, Article 97 (2) (5) of the Medicinal Products Act.
Non-official table of contents

§ 5 Berlin clause

This regulation in accordance with Section 14 of the Third Transfer Act, in conjunction with Section 99 of the Medicines Act, also in the Land of Berlin. Non-official table of contents

§ 6 Entry into force

(1) This Regulation occurs on the 1. April 1985, in force.(2) Medicinal products which are 1. By 31 April 1985, the marketing authorisation holder may still be in the market until 31 April 1985. December 1985 and by wholesalers and retailers up to 31 December 1985. It will continue to be placed on the market in December 1986 without the mandatory warnings or warnings which have been ordered by the competent federal authority pursuant to Section 28 of the Medicines Act before the entry into force of the Regulation.(3) Medicinal products which do not comply with the provisions of § § 1 to 3a and which are placed on the market in the area referred to in Article 3 of the Agreement on entry into effect of accession may still be used by pharmaceutical companies until the end of the period of 31. They shall also be placed on the market by wholesalers and retailers, provided that they comply with the provisions of the German Democratic Republic concerning the effective application of the accession of the European Union. Non-official table of contents

Final formula

The Federal Minister for Youth, Family and Health