Regulation on the labelling of medicinal products in the case of micro-quantities (Braille-Labelling Regulation)

Unofficial table of contents

BlindKennzV

Date of completion: 14.07.2006

Full quote:

" Blindenschrift-Labelling-Regulation of 14 July 2006 (BGBl. I p. 1696) "

Footnote

(+ + + Text evidence from: 1.9.2006 + + +) Unofficial table of contents

Input formula

Pursuant to Section 12 (1), first sentence, No. 2 of the Medicinal Products Act, as amended by the Notice of 12 December 2005 (BGBl. I p. 3394), the Federal Ministry of Health, in agreement with the Federal Ministry of Economics and Technology, is responsible for: Unofficial table of contents

§ 1 Scope

This Regulation shall apply to medicinal products for use in humans intended for use in human beings subject to the provisions of the legislation on labelling in the form of a blind text, and to a minimum quantity of up to 7,000 persons in the pharmaceutical sector. Packs are placed on the market in one year. Unofficial table of contents

§ 2 Labelling of micro-quantities

For the medicinal products referred to in § 1, the information required in accordance with § 10 (1b) of the German Medicines Act must not be affixed, provided that the pharmacy is supplied by the pharmacy to blind or partially sighted persons. shall be affixed to an adhesive label on the package or, if it is not possible because of the size of the name, on an information sheet; appropriate abbreviations may be used in the Braille and normal letters on the package. shall be used. The information in Braille referred to in the first sentence shall be provided by the pharmaceutical company. Unofficial table of contents

§ 3 Entry into force

The Regulation shall enter into force on 1 September 2006. Unofficial table of contents

Final formula

The Federal Council has agreed.