The IAG. Who are they?

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The mention of the IAG can strike fear into the hearts of many wholesalers… usually those who are not compliant with GDP.

So, who are the IAG?

The letters IAG stand for “Inspection Action Group” and they’re a multidisciplinary team that are part of the MHRA.

IAG 1, responsible for GDP, GMP and blood banks meets (usually) on the first and third Tuesday of each month.

IAG 2 are responsible for GCP (Good Clinical Practice) and GPvP (Good Pharmacovigilance Practice).

When might you come into contact with the IAG?

Your MHRA inspector will advise the IAG if they find critical deficiencies during an inspection or if agreed action plans from previous inspection deficiencies have not been resolved and have escalated your risk profile.

Other referrals may come from licence variations, when organisations cannot be contacted to arrange an inspection (which may result in a  licence cancellation), if an organisation refuses to accept an inspection, as an outcome of enforcement activity, result of a product recall or due to an issue raised by another EU member state.

The IAG will review the case, and the inspector will give their professional opinion.

View this page on “Actions as a result of referral to the IAG.”

The IAG can propose removal of the RP or suspension of your licence, increase inspection visits or request a meeting with the licence holder.

View our post on the inspection process HERE and the application process for a WDA HERE

 

What should you do if you’re referred to the IAG?

You should immediately set out to correct any deficiencies that caused the referral and then report the completed actions to both the MHRA and IAG. Each deficiency should be answered, with a planned corrective action, and timeline (based on risk, and reflective of the amount of work required). “Woolly” answers, over-long or short timescales or a lack of understanding can escalate your risk of suspension/force variation.

If the referral leads to an immediate suspension of your licence (typically starting at 3 months – unless there are serious issues, when it can be 6 or more months) you will have no rights to appeal, but the decision can be challenged in the High Court.

If it leads to a proposed suspension, variation or revocation of the licence, you can make a written representation to the MHRA or have a person appointed meeting (by the MHRA)… for £10,000.

 

What is the true cost of IAG interest?

As you will see from our post on MHRA suspended licences the cost of non-compliance can be far more than fiscal pain.

Being referred to the IAG could cost you a significant amount of money. A person appointed hearing will set you back £10,000! A re-inspection will be needed to make sure the deficiencies have been corrected, and this will cost you a further £1936.

It could also lead to a loss of business (as your licence may be suspended) which will mean a further loss of money.

Furthermore, at the MHRA Symposia 2018, it was suggested that CMT or IAG cases may attract further costs.

Losing money and customers can have a detrimental effect on your business, especially on small companies.

If you need help correcting deficiencies or are worried about an upcoming inspection, contact us at info@paradigmshiftconsulting.co.uk and we can arrange a free initial, no obligation consultation.

Need training? We offer two-day training sessions on the EU GDP guidelines, and if needed (with enough time) can create bespoke sessions to cover the areas you need most.

Take a look at our training page for more details, training dates and to book a place.

Welcome to a new Paradigm!

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