WDA Suspended, Terminated, Cancelled, and Revoked: What do these terms mean?

Suspended, Terminated, Cancelled and Revoked explained!

An MHRA (other competent authorities are available!) Wholesale Distribution Authorisation (for medicines for human use – WDA[H]), is the licence issued by the MHRA (Medicines and Healthcare products Regulatory Agency) to wholesalers of Human Medicines. For veterinary medicines this license is a WDA(V).

These licences are granted and inspected against GDP guidelines and Human Medicines Regulations 2012 by MHRA GDP Inspectors, or in some cases GMDP Inspectors, depending on the additional licences held, such as MS (Manufacturer Specials) for example.

Inspections are scheduled in accordance to a RBI (Risk Based Inspection) process, which is driven by the compliance record of the site, and also links to suppliers or customers, or third parties, who are under MHRA, IAG or Enforcement investigation or action.

The compliance status of your site is the key driver, however being linked to companies who are found to be involved in criminal activity, supply or distribution of falsified medicines, or serious non-compliance can also affect your RBI schedule… including surprise or short notice inspections.

What does ‘Suspended’, ‘Terminated’, ‘Cancelled’ and ‘Revoked’ mean, in relation to an MHRA granted licence?

When a site is found to be critically non-compliant, a post inspection letter is issued, generally with a 7 to 14 days response time, depending on the risk to human health.
In lower risk scenarios the case may be assigned to the Compliance Management Team (CMT), but typically it is allocated to the Inspection Action Group (IAG).

The site Responsible Person (RP) and Licence Holder (LH) will have an opportunity to respond to the deficiencies, providing a course of action and timeline, which should be based on CAPA principles and a realistic time to close each action, based on risk.

In the event that part or all of the response is deemed not acceptable, a proposed notice of suspension or proposed notice to remove the Responsible Person (or both) will be issued. The site then has a final opportunity to give sufficient remediation strategies in a response.

If this response is not successful then the licence will be suspended, and be posted to the list of MHRA Suspended Licences (sometimes referred to by a few as the “Wall of Shame”).

The length of suspension will be based on how long the site may require to remediate the risk to patient safety and regain compliance, starting at three months, or as long as twelve months in severe cases. However, the affected site can request inspection and reinstatement of the licence sooner, if enough work is carried out and a re-inspection occurs. It is possible to bring a site out of suspension “early” and the initial period is a guide. Sites can also be further suspended if the IAG believe the company has made progress with the remediation works but compliance levels are not quite there yet.

The MHRA Suspended and Revoked page states:

“The Medicines and Healthcare products Regulatory Agency (MHRA) may suspend a licence to wholesale or manufacture medicines and medical products if it:

• • identifies safety issues
  • needs to investigate a licence holder”

A Terminated Licence

A termination of the licence is when the licence is surrendered by the Licence Holder, NOT “taken” by the MHRA, as we have seen written in some places.
Typically, a licence is terminated when there is no further need for it, for example, when a change in business model no longer requires a licence to be in place.

Alternatively, a licence may be terminated when the site is so noncompliant that it will take so much resource to resolve that it is not viable to continue.

Paradigm Shift Consulting offer a FREE review and also a FREE termination service in the rare situations that a licence will not be able to be saved.

When do we terminate?

Usually prior to a suspension, or post suspension to prevent revocation.

Over the years, we have been offered large sums of money to assist in retaining licences, however our team always say it’s a bad idea to ask a consultancy to do work “no matter what the cost,” especially if there is no way of the site realistically continuing safely, compliantly, or receive any return on investment.

We gain no pleasure in working solely for money, and without benefit to the supply chain or patients. Therefore have worked with dozens of failed sites to liaise with the MHRA, close off the site and terminate the licence at no cost.

Cancelled Licence:

A licence is typically cancelled by the MHRA when the Licence Holder or company are unable to be contacted.

Revoked Licence:

A revocation is when the MHRA take away your licence, for serious noncompliance, or escalation thorugh the MHRA’s IAG or CMT systems evidencing that the site, RP and/or LH do not have control. Typically, a site is suspended first, however there have been a few small incidences of sites being revoked immediately.

Paradigm Shift Consulting  offer a FREE review of your MHRA post-inspection documentation and a FREE termination service in the rare situations that a licence will not be able to be saved.

However, prevention is better than cure!  We advise WDA holders to periodically perform a full QMS audit and gap assessment of your entire GDP operations to identify any noncompliance issues and address and resolve them in advance of a regulatory inspection.  It is far better to inform an inspector on the day of the inspection of any deviations against compliance that you have identified and are in the process of correcting through a CAPA or Change Control, than it is to have them find the issues during their inspection.   

Paradigm Shift can perform full audits and gap assessments, review your documentation, review and rework your standard operating procedures and provide GDP training to your staff. 

Why do we offer a free service? 

At Paradigm Shift Consulting we aim to revolutionise healthcare by providing strategic consulting and innovative solutions that ensure patient safety and create a more quality and compliance focused industry by partnering with organisations to address compliance challenges and drive positive quality culture.

With these aims in mind, we offer free consultations and services to help organisations understand their obligations and instil patient safety at the core of their operations. 

Our team of consultants are here to support compliance.
When we fail, and most sites do at some point or another, compliance at all times should be considered as the foundation of that licence being in place.

Backup, Support and Training

Contact us for support using the form below. We may ask for an executive summary of your business to assist with our assessment and advice on any matter you present us with.

Browse our GDP Training website using the link button below for training courses, other blogs on GDP matters, study/help materials and advice.
We also run a monthly intensive all day online Webinar on Good Distribution Practice for RPs and Management, covering all ten chapters of the current EU GDP Guidelines. Places on the Webinars fill quickly – be sure to book in advance!

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