Regulation on the prohibition of the use of ethylene oxide in medicinal products
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Ethylene oxide
Date of completion: 11.08.1988
Full quote:
" Regulation prohibiting the use of ethylene oxide on medicinal products of 11 August 1988 (BGBl. I p. 1586), most recently by Article 9 of the Law of 17 July 2009 (BGBl. 1990).
Status: |
Last amended by Art. 9 G v. 17.7.2009 I 1990 |
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Notes
Footnote
(+ + + Text certificate: 20.8.1988 + + +)
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Input formula
On the basis of § 6 (1) and (2) and § 83 (1) and (2) of the Medicinal Products Act of 24 August 1976 (BGBl. 2445, 2448), Section 6 as amended by Article 1 of the Third Jurisdiction Adjustment Regulation of 26 November 1986 (BGBl. 2089), will be arranged in agreement with the Federal Minister for Food, Agriculture and Forestry:
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§ 1
(1) It is prohibited to use ethylene oxide in the manufacture of medicinal products which consist of plants or parts of plants. (2) It is prohibited to use medicinal products which consist of plants or parts of plants and which are used with ethylene oxide have been produced and put into circulation.
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§ 2
(1) According to § 95 (1) No. 2 and (2) to (4) of the German Medicines Act, the person who intentionally or negligently puts the medicinal product on the market in breach of § 1 (2) shall be punished. (2) According to § 96 (2) of the German Medicines Act, it shall be punished who is contrary to § 1. (3) Anyone who is negligent in committing an act referred to in paragraph 2 shall act in an orderly way in accordance with Article 97 (1) of the Medicines Act.
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§ 3
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.
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§ 4
(1) This Regulation shall enter into force on the day following the date of delivery, subject to the rules laid down in paragraph 2. (2) In the manufacture of medicinal products which consist of dried plants in unshredded or coarsely cut form, and which: are intended to be placed on the market in the same state, the use of ethylene oxide for the reduction of disease germs is authorised until 31 December 1990.
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Final formula
The Federal Minister for Youth, Family, Women and Health