MGN 524 (M+F) Amendment 1 - Life-saving appliances – category C medical kits
Companies procuring, storing, distributing or supplying Category C (either as stand alone kits or contained within packed survival craft)
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This Notice provides guidance to all marine companies procuring, storing, distributing or supplying Category C medical kits (either as stand-alone kits or contained within packed survival craft) on the requirements and process for obtaining a wholesale distribution authorisation in accordance with the Human Medicines Regulations 2012 (SI 2012 No. 1916) (as amended). Sections 2 and 3 of this MGN give details of the organisations to which these regulations apply and the process of obtaining the required authorisation.
Amendment 1 provides up to date references to MHRA regulations throughout the document.
This notice should be read with the Human Medicines Regulations 2012 (as amended), MSN 1905 (M+F), MSN 1676 (M) & EC Directive (EU) 2019/1834.
Notice to all :-
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owners and operators of UK ships and small commercial vessels
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survival craft service stations and agents
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manufacturers and distributors of category C medical kits
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manufacturers and distributors of survival crafts containing category C medical kits
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chandleries supplying survival craft containing category C medical kits or category C medical kits as a standalone product.