To ask Her Majesty's Government whether monitoring takes place of unsterilised botulinum toxins offered for sale from overseas on the internet. [HL58]
To ask Her Majesty's Government what monitoring takes place to ensure that imports of unsterilised botulinum toxins are sterilised for cosmetic or other uses. [HL59]
To ask Her Majesty's Government further to the Written Answer by Baroness Thornton on 5 October (WA 440), what steps they are taking to ensure that imports into the United Kingdom of unsterilised botulinum toxins do not give rise to outbreaks of botulism. [HL60]
The Medicines and Healthcare products Regulatory Agency (MHRA) monitors the internet for medicines and active pharmaceutical ingredients that are being offered for sale or supply. Where the agency determines that supply and advertising is illegal and where patient safety is compromised it will take appropriate action.
European Union manufacturers of licensed products containing botulinum toxin that are imported into the United Kingdom are inspected by the relevant regulatory authorities in the countries of origin. An aspect of inspection is to ensure that sterilisation processes are effective and fully validated. Third country manufacturers are inspected by the relevant supervisory authority, when arrangements for sterilisation are also reviewed. A condition applied to the importation of unlicensed products is that they are manufactured under appropriate standards of good manufacturing practice by the holder of an appropriate manufacturing licence.
Manufacturers are required to show beyond that specified in the marketing authorisation for therapeutic effects. These controls aim to ensure that imports of unsterilised botulinum toxin are not imported and give rise to outbreaks of botulism