The Medicines and Healthcare products Regulatory Agency (MHRA) and the Maritime & Coastguard Agency (MCA) are jointly issuing a warning that imported liferafts may contain unlicensed imported medicines, as well as medical devices that do not carry a CE Mark.
Suppliers of inflatable liferafts in the UK are asked to check the origin of their liferafts immediately to establish if any of the contents of the medical kit inside is compliant with UK medicines legislation.
This is because medical kits containing unauthorised imported medicines and medical devices may have been supplied inside inflatable liferafts to ships, fishing vessels, small commercial vessels and pleasure boats. MCA has issued a safety bulletin on this issue.
Suppliers of imported liferafts are asked to open at least one liferaft from each non-UK liferaft supplier they deal with and check that the medical kit only contains medicine and medical devices authorised for use in the UK.
This follows an MHRA inspection which found that some UK liferaft service stations, manufacturers and distributors of liferafts had been importing and supplying inflatable liferafts with medical kits that contain medicines and medical devices which originated from China and are not authorised for use in the UK. If the kit contains unauthorised medicines or medical devices it should be disposed of by an approved pharmaceutical waste contractor.
Seasickness pills (which are stored within the liferaft but separate to the medical kit, and in the case of pleasure vessels can be supplied in isolation) must be authorised for supply in the UK and handled in accordance with UK medicines legislative requirements.
Members of the public should note that these medicines are only likely to be made available and consumed in the rare event of a liferaft being deployed in an emergency.
Owners of liferafts who have any doubt as to the compliance of the medical kits within their liferafts should contact the liferaft supplier or service station who serviced, sold or rented the liferaft to them for advice.
Gerald Heddell, MHRA director of inspection, enforcement and standards said: ‘It is important that the medical kits contained in these liferafts only contain medicines and medical devices authorised for use in the UK. Whilst they are only likely to be taken in the rare event of a liferaft being deployed in an emergency it is important they are of the right quality and standards.
‘If the kit does not contain authorised medicines or medical devices they should be returned to the supplier for disposal at an approved pharmaceutical waste disposal site.
‘Anyone who has used medicines or medical devices originating from a medical kit on an inflatable liferaft and who is concerned should contact their healthcare professional for advice.’
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