Medicines (Labelling) Regulations, 2010
Country
Type of law
Regulation
Abstract
These Regulations, made under section 81(1) of the Medicines Order, 2007, establish requirements for the labelling of medicinal products. They prescribe the particulars to be displayed on containers and packages of medicinal products, requirements concerning the declaration of specified substances and expiry dates, and standards concerning the presentation and durability of labels. The Regulations also provide specific exceptions to certain labelling requirements.
For dispensed medicinal products, the container shall indicate the name of the person to whom the product is to be administered; the name and address of the medical or dental practice, registered pharmacy, hospital or other supplying or dispensing institution; the dispensing date; directions for use; and the name of the medicinal product. Where the appropriate non-proprietary name is used, the label shall also indicate the appropriate quantitative particulars of the active ingredients. Medicinal products administered in clinical trials are exempt from certain requirements concerning the indication of the product name and active ingredients. The Regulations define relevant terms, including appropriate non-proprietary name, dispensed medicinal product, expiry date and international non-proprietary name.
Medicinal products for human consumption or use containing substances listed in the First Schedule, when subject to the conditions specified in the Regulations, shall bear an English-language statement declaring the presence of the relevant substance. Containers and packages of medicinal products containing substances listed in the Second Schedule shall, subject to specified exceptions, display a “Use by” or similar statement followed by the expiry date. The Regulations provide exceptions concerning certain vitamin C products sold as confectionery and specified substances supplied wholesale for use as ingredients in preparations intended for medicinal purposes.
The Regulations further prescribe standards for the dimensions, legibility, position and manner of medicinal product labelling. Required particulars shall generally be printed in letters of at least 1.5 millimetres in height, be clearly legible and appear prominently. Specific provisions apply to small containers and packages and to blister or other sealed-unit packaging. Additional descriptive information may be included in any language provided that it does not contradict or modify the required particulars. Labelling of medicinal product containers and packages shall be indelible.
For dispensed medicinal products, the container shall indicate the name of the person to whom the product is to be administered; the name and address of the medical or dental practice, registered pharmacy, hospital or other supplying or dispensing institution; the dispensing date; directions for use; and the name of the medicinal product. Where the appropriate non-proprietary name is used, the label shall also indicate the appropriate quantitative particulars of the active ingredients. Medicinal products administered in clinical trials are exempt from certain requirements concerning the indication of the product name and active ingredients. The Regulations define relevant terms, including appropriate non-proprietary name, dispensed medicinal product, expiry date and international non-proprietary name.
Medicinal products for human consumption or use containing substances listed in the First Schedule, when subject to the conditions specified in the Regulations, shall bear an English-language statement declaring the presence of the relevant substance. Containers and packages of medicinal products containing substances listed in the Second Schedule shall, subject to specified exceptions, display a “Use by” or similar statement followed by the expiry date. The Regulations provide exceptions concerning certain vitamin C products sold as confectionery and specified substances supplied wholesale for use as ingredients in preparations intended for medicinal purposes.
The Regulations further prescribe standards for the dimensions, legibility, position and manner of medicinal product labelling. Required particulars shall generally be printed in letters of at least 1.5 millimetres in height, be clearly legible and appear prominently. Specific provisions apply to small containers and packages and to blister or other sealed-unit packaging. Additional descriptive information may be included in any language provided that it does not contradict or modify the required particulars. Labelling of medicinal product containers and packages shall be indelible.
Attached files
Web site
Date of text
Entry into force notes
These Regulations enter into force on 1 July 2010
Repealed
No
Serial Imprint
Brunei Darussalam Government Gazette, No. S 69
Source language
English
Legislation Amendment
No
Implements