Maritime Alert issued on the 10 November 2014 “Medicines distribution in the maritime sector” by the MHRA.
The MHRA, had issued a deadline for the maritime sector to achieve compliance. All organisations that wished to continue to wholesale medicines were required to apply for a WDA (H) and all applications had to be made by the 1st December 2014.
This included the sale or supply of anti-seasickness tablets, First Aid Kits with medicines such as Cat C Kits or life-rafts containing medicines.
Any companies continuing to wholesale medicines without a WDA(H) are liable to enforcement action.
Several clients were concerned about what they had to do to attain their WDA(H) and we have helped them as they wanted to carry on supplying medicines both inside and outside life rafts.
The Pharmacy Consulting solution
The needs of these clients were diverse and their knowledge base varied. The biggest problem was denial and mixed messages being given. The solutions were bespoke for each client. In most cases we encouraged them to come for some training and several clients did attend our GDP/RP training and audit training. The next step carried out was to attend the client’s administration and storage sites and create GAP analysis with recommendations on how to meet the requirements prior to their inspection.
PCL has supported their RP and have also provided practical assistance in how to use the new MHRA portal, drafting working procedures and developing a robust Quality System.
We have attended their MHRA inspection which was successful and resulted in the company being complimented upon its pre-inspection preparation and given a low risk score and four years until their next MHRA inspection.
If you have not applied for your WDA yet and want to please get in touch as soon as you can, although your application is not in place yet and you have missed last year’s deadline, you will be looked on more favourably if you apply as soon as possible.
We guided the clients through the whole application process, giving feedback and corrective actions when required to ensure that they were ready for their inspection.
By training, coaching and working with the client to improve their Quality System and working knowledge of GDP the clients achieved a lower risk score and this will save them money in the long run as they will have a longer time between their subsequent MHRA inspections.