The MHRA has today, 10th November 2014, published their guidance on their expectations for the supply of medicines to the maritime sector.
http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON473634
Any UK marine company procuring, storing, distributing or supplying Medical Kits that contain medicines (either as stand-alone kits or contained within packed survival craft) is now required to obtain a Wholesale Distribution Authorisation issued by the MHRA.
Anyone who is procuring, distributing or supplying these kits without a WDA(H) is operating outside of the law and is now required to apply for a WDA(H) before the 1st December, 2014.
In addition, the Maritime & Coastguard Agency (MCA) has issued their Marine Guidance note MGN 524 (M+F).
If you haven’t already applied for your WDA(H), contact PCL for your ‘one stop shop’ for your Good Distribution Practice (GDP) compliance and for details of our Marine Sector GDP training days.
If you are unsure if you require a WDA(H), PCL are able to advise you.
Contact details: +44(0) 1252 302 342