Regulation On The Labelling Of Medicinal Products In Braille For Small Quantities

Original Language Title: Verordnung über die Kennzeichnung von Arzneimitteln in Blindenschrift bei Kleinstmengen

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Regulation on the labelling of medicinal products in Braille for small quantities (Braille-labelling regulation) BlindKennzV Ausfertigung date: 14.07.2006 full quotation: "Braille labelling regulation by July 14, 2006 (BGBl. I S. 1696)" footnote (+++ text detection from: 1.9.2006 +++) input formula on the basis of § 12 para 1 sentence 1 No. 2 of the German medicines act as amended by the notice of December 12, 2005 (Federal Law Gazette I pp. 3394) ordered the Ministry of health in consultation with the Federal Ministry of Economics and technology : § This Regulation applies 1 scope for medicinal use in humans, which are subject to the drug regulations about labeling in Braille and marketed by a pharmaceutical entrepreneur in small quantities up to 7,000 packages a year on the market.

Section 2 labelling of small quantities for the medicinal products referred to in article 1 must b of the German medicines act not mounted information required according to § 10 para 1, provided with a supply of medicinal by the pharmacy to blind or visually impaired persons this be brought to information in Braille and regular font on an adhesive label on the package or, if this is not possible due to the size of the label , separately on a sheet of information transmitted; appropriate abbreviations can be used. The information in Braille pursuant to sentence 1 is to deploy the pharmaceutical entrepreneur.

Article 3 entry into force of the regulation enters into force on September 1, 2006.

Concluding formula the Federal Council has approved.