UK MHRA alerts companies to BSI standard on use of Braille
This article was originally published in SRA
The UK Medicines and Healthcare Products Regulatory Agency has issued an alert informing pharmaceutical companies about a BSI standard that provides guidance on the use of Braille on the packaging of medicinal products1,2. Companies demonstrating compliance to the standard (BS EN 15823:2010 Packaging: Braille on packaging for medicinal products), the agency says, will be regarded as meeting the regulatory provisions of the EU medicines legislation (Directive 2001/83/EC, as amended).
You may also be interested in...
Remote inspections are here to stay, and global regulators are aligning efforts to develop consensus on how these should be conducted.
The Canadian medtech regulator has recommended updating its list of recognized medical device standards that manufacturers can rely on to demonstrate compliance with local safety, effectiveness and labeling requirements.
Reports from Norway about deaths in very frail, elderly patients soon after receiving Pfizer/BioNTech’s COVID-19 jab have drawn regulatory scrutiny. While the European Medicines Agency has launched an investigation, Australia is examining the need for specific warnings about risks of vaccination in the very frail elderly or terminally ill patients.