Consultants from Paradigm Shift have supported a number of companies in their journey out of MHRA licence suspension, some of whom had taken legal advice, or had engaged solicitors to fight their case, in advance of contacting us.
Quite often by the time Paradigm are contacted it’s too late.
Typically we receive notice from people just before or just after they have been suspended.
Why are people suspended by the MHRA or Inspection Action Group?
There are any number of reasons, but typically lack of compliance with the EU Guidance on Good Distribution Practice for medicines for human use, illegal sale of products, poor controls or lack of knowledge and due care.
The biggest deficiencies found by the MHRA are now related to the updated guidance from 2013, where the regulation increased almost four times in scope and detail.
The most common critical findings that can lead to suspension include the Responsible Person failing to implement and maintain a quality management system, mishandling product returns, or failing to appropriately investigate and evidence outcomes from temperature deviations.
Our advice to anyone considering using a solicitor / lawyer when interacting with the MHRA relating to removal from the licence as a Responsible Person, a proposed suspension, or anything where you have not DELIBERATELY breached the regulations, is simple –
“DON’T DO IT!!!”
If you have been involved in criminal activity, buying products for cash, or from unlicensed sites knowingly, and deliberately trying to flout the regulations and law, a solicitor may be just what you need.
We know a number of criminal solicitors who may be able to help.
Here are a few reasons why not to recruit a solicitor or lawyer when interacting with the MHRA or IAG:
1) Cost – We have seen some clients being billed over £500 per hour for legal support, that has ultimately only incurred them significant costs and hasn’t closed out the deficiencies quickly and efficiently.
2) Counter-productive Actions – When the MHRA or IAG receive a letter from a lawyer or solicitor stating that their client believes that they are right and the MHRA / IAG are wrong… or requesting further information (like sections of the Human Medicines Regulations 2012, readily available via Googling) the result is never positive. Generally things are clear, cut and dried… take your hits and resolve them within the suggested timescale.
3) Lack of experience and knowledge – There are few lawyers and solicitors that are experienced in Good Distribution Practice, and the letters sent often demonstrate this lack of understanding and generate more issues.
4) Solicitors and Lawyers often ask for further information – we have seen solicitors and lawyers asking the MHRA / IAG for further information relating to the deficiencies, or even disputing them, and asking the MHRA / IAG to further prove the guilt.
This is not to say that all lawyers or solicitors are made equal. Do your due diligence and you may find a team who are cost effective and knowledgeable and who will represent you well.
There are some legal firms with more experience in GDP matters, however they are often still cost prohibitive.
Please note that those involved in criminal activities or have knowingly breached GDP for profit may well be better off with a lawyer / solicitor, as Paradigm avoid anyone who actively skirts the regulations.
How can you stay free of regulatory action?
– Be compliant with EU GDP 2013/C 343/01 – and get training on the specific business activities you do.
– Evidence your compliance with good documentation and records of activities, including outsourced activities.
– Implement and maintain a quality management system.
– Understand your legal requirements, and be compliant – if you don’t know, why don’t you know?
– Don’t cut corners – resource your business with properly trained staff, maintain your equipment and facility.
– Focus on quality – hold regular quality and improvement meetings.
– Aim for excellent… miss and you may still be “good.”If you don’t know what you are doing… don’t wait… ask for help.
10 Mar 2020
2 Apr 2019
2 Apr 2019
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