Drug Warning Notice Regulation

Original Language Title: Arzneimittel-Warnhinweisverordnung

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Read the untranslated law here: http://www.gesetze-im-internet.de/amwarnv/BJNR000220985.html

21.12.1984 drug warning note prescription (AMWarnV) AMWarnV Ausfertigung date: full quotation: "drug warning note Decree of 21 December 1984 (BGBl. 1985 I p. 22)" footnote (+++ text detection from: 1 4.1985 +++) (+++ changes due to EinigVtr see) § 6 +++) (+++ stand: EinigVtr v. 31 8.1990 conjunction with art. 1 G v. 23 9.1990 +++)-BGBl. II 1990, 885, 1085 - input formula on reason of § 12 para 1 Nos. 1 and 3 of the German medicines Act of 24 August 1976 (BGBl. I p. 2445, 2448) is prescribed in the agreement with the Federal Minister of economy with the consent of the Bundesrat: § 1 scope, expansion of provisions of the medicines Act (1) this regulation is to apply to medicinal products in the sense of § 2 paragraph 1 or paragraph 2 No. 1 of the German medicines Act , which are intended to be placed in a package destined for delivery to the consumer in the traffic and the 1st ethanol are included and are intended for internal use in humans, if they a) are liquid preparations for oral intake and the ethanol content in the maximum single dose after the dosage is at least 0.05 g or b) are injectable solutions, infusion solutions, disinfectant or sanitizer and the ethanol content is at least 0.05 g in the maximum single dose after the dosage or 2 TARTRAZINE are included and are intended for use in humans.
Article 10, paragraph 1 and 2 and article 11, paragraph 1 and 2 of the German medicines Act apply, insofar as they pertain to providing the warning provided for in this regulation, for medicinal products pursuant to sentence 1, which are not finished medicines.
(2) this Regulation shall not apply to medicinal products intended for clinical trials.

§ 2 warning on the containers and outer packages for medicinal products (1) § 1 para 1 sentence 1 No. 1 letter a may be brought only in the traffic, when stating the Volumprozent content of ethanol the following warnings are attached: 1. for medicinal products that contain 0.05 g in the maximum single dose after the dosage up to 0.5 g ethanol: "contains... Vol.-% alcohol."and 2. for medicinal products are included in the maximum single dose according to the dosage of 0.5 g ethanol:"contains... Vol.-% alcohol; Leaflet note! "."
(2) pharmaceutical products no. 1 letter b are allowed according to section 1, paragraph 1, sentence 1 only in the traffic, when stating the Volumprozent content of ethanol the warning 'contains... Vol.-% alcohol."is attached.
(3) medicinal No. 2 may be placed only in the traffic according to section 1, paragraph 1, sentence 1, if the warning 'contains TARTRAZINE; Leaflet please!"is attached.
(4) the warning labels must be affixed on the containers and outer packages in clearly legible and durable manner.

§ 3 warning on the package insert (1) medicines to § 1 para 1 sentence 1 No. 1 letter a may be brought only in the traffic, if a warning is attached to the leaflet clearly legible, the stating of the Volumprozent content of ethanol 1 medicines that contain 0.05 g in the maximum single dose after the dosage up to 0.5 g ethanol , has the following wording: "contains... Vol.-% alcohol. ", 2. for medicinal products contained in the maximum single dose after the dosage up to 3.0 g ethanol, about 0.5 g has the following:"warning this medication contains... " Vol.-% alcohol. The dosage instructions g occur to each taking up to... alcohol. A health risk is including Leberkranken, alcoholic, epileptics, brain-damaged, pregnant women and children. The effect of other drugs can be hindered or enhanced.' and 3. medicines contained in the maximum single dose after the dosage over 3.0 g ethanol, has the following: "warning this medication contains... Vol.-% alcohol. The dosage instructions g occur to each taking up to... alcohol. Caution is advised. This medicine must not be applied in Leberkranken, alcoholic, epileptics, brain-damaged, pregnant women and children. The effect of other drugs can be impaired or amplified. In road transport, and in the operation of machines the responsiveness can degrade."
In the warnings pursuant to sentence 1 No. 2 and 3 is the number of specified for taking teaspoons, Tablespoons, after the word "Taking" to indicate measuring spoon, measuring cup, or a different amount in the dosing instructions given in parentheses.
(2) pharmaceutical products no. 1 letter b are allowed according to section 1, paragraph 1, sentence 1 only on the market, if a warning is attached to the leaflet clearly legible which is worded, stating the Volumprozent content of ethanol: "contains... "Vol.-% alcohol".
(3) medicinal products no. 2 are allowed according to section 1, paragraph 1, sentence 1 only on the market, if a warning is attached to the leaflet in easily legible characters which reads: "Warning this product contains the dye TARTRAZINE, which can cause allergy-like reactions in individuals who are especially sensitive to this substance,".
(4) paragraphs 1 to 3 shall apply to medicinal products, the 1st in the individual case on special request or order made 3 will, be, brought 2. pursuant to article § 11 par. 2 of the law on the restructuring of the pharmaceutical legislation without leaflet in the traffic only then, if the prescribed warning in paragraph 2 warning referred to, and with the proviso that the warning referred to in paragraph 1 , 2 or 3 in easily legible characters must be included with or attached to him the container.

§ 3a warning on the prescribing information that prescribed warning is according to article 3, paragraph 1, 2 or 3 to indicate to the prescribing information.

Section 4 offences who intentionally or negligently 1 to § 2 medicines without the required warning in the traffic brings, is according to § 97 para 2 No. 4 of the German medicines Act disorderly or 2. contrary to article 3, paragraph 1, takes 2 or 3 drugs without the required warning in the traffic, is according to § 97 paragraph 2 No. 5 of the German medicines Act rude.

§ 5 Berlin clause this Regulation shall apply to § 14 of the third of transfer Act in conjunction with section 99 of the medicines Act in the Federal State of Berlin.

Article 6 entry into force (1) this regulation enters into force on April 1, 1985.
(2) pharmaceutical products, located on 1 April 1985 in the transport sector, are allowed further by the pharmaceutical entrepreneur until December 31, 1985 and from wholesalers and retailers until 31 December 1986 without the prescribed warnings or with the warnings that have been ordered before entry into force of the regulation by the competent federal authority according to § 28 of the German medicines Act, in the traffic.
(3) medicinal products which do not comply with the provisions of §§ 1 to 3a and which are to be of accession in the area referred to in article 3 of the Unification Treaty in circulation, may be placed there by pharmaceutical companies until December 31, 1991 and thereafter by wholesalers and retailers in the market, provided they meet the applicable before accession becomes effective medicines regulations of the German Democratic Republic.

Concluding formula of the Federal Minister for youth, family and health