Holders of a Wholesale Distribution Authorisation (Wholesale Dealer Authorisation) can be suspended for a number of reasons, but most commonly to regulatory action from the MHRA (Medicines and Healthcare products Regulatory Agency).
Paradigm Shift Consulting have worked with many customers who have experienced MHRA regulatory action resulting in suspension of the licence and being listed on the public MHRA Suspended Licence list.
Paradigm have assisted with remedial works, or placing a contract RP, resulting in the lifting of the suspension.
Appearing on the MHRA Suspended Licence list can have a detrimental, or even terminal, effect on your business, and your reputation.
The company that has an MHRA suspended licence cannot trade, suffers loss of credibility, loss of earnings and a reduced inspection schedule, which adds further costs and regulator interaction. At £1936 per MHRA inspection or re-inspection, you want as few visits as possible… and that comes with compliance.
Remain inspection ready, read our helpful blog, keep up to date and don’t do anything “grey” and you will certainly get a better inspection result. If you are finding EU GDP 2013/C 343/01 and MHRA expectations too taxing, contact us for a free five minute consultation.
The MHRA suspended licence list, and list of revoked licences, can be found HERE
When you type “MHRA Suspended Licence” into Google (other generic search engines may offer different results) this is the first search term that will appear.
This webpage is an essential part of your bona fides checks, and should be reviewed twice per month, and you must evidence that this check has been made.
Suspended sites should advise you that they have been suspended as soon as it happens, but in the case of companies who interact with many this may not always be the case. You have a responsibility to ensure that your MHRA Suspended Licence Checks are up to date.
With the regulator accepting electronic evidence (with suitable back up) we recommend you take a screenshot, and save it as a jpeg image, with the date that you screen grabbed.
Unsure how to take a screenshot?
• Navigate to the MHRA page link above, or google “MHRA Suspended Licence”
• Scroll down to the list of suspended or revoked licences
• Look to the top right of your keyboard and press “Print Screen” or “prt sc”
• Then open the “Paint” program or a similar program if you don’t have a Windows PC/laptop
• “Paste” the image
• Save in your “MHRA Suspended Licence Check” folder as, for example, “MHRA Suspended Licence Check 24 September 2018”
You must have you MHRA Suspended Licence Checks saved on a PC that is backed up (at a separate and secure location… not to a memory stick plugged in the back!) so generally your server or PMR (Patient Medication Record) if you are a pharmacy wholesaler.
MHRA Suspended Licence checks are a critical part of your Quality Management System and Risk Management processes, so keep on top of them.
We find an easy way to remember is to set a recurrent reminder in your Outlook calendar or Gmail diary. Personally we recommend every alternate Wednesday, but monthly “may “be deemed acceptable if you are a small “skimming” site, buying from the main wholesalers like Alliance and AAH, if a risk assessment has been carried out.
Many people use a checklist, where they sign off the checks or tick a box, we prefer the screen grab as it shows a genuine moment in time and cannot easily be falsified.
Even better, hover the cursor over the clock at the bottom right of your screen and it will give you a time, day and date of your MHRA Suspended Licence Check, something that cannot be changed.
If you buy from, or supply, a site that has been placed on the MHRA Suspended Licence list you will be at risk of regulatory action yourself.
Don’t fall foul of the law, or the regulator, and make sure you do your due diligence.
Want support, or help with your bona fides checks? We offer a range of compliance support membership packages.
If you need training, take a look at our training calendar for dates.
Contact us for more information at email@example.com
2 Apr 2019
2 Apr 2019
12 Feb 2019
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