Inspection Action Group

The Inspection Action Group (IAG) is a non-statutory, multi-disciplinary group constituted to advise the Director of the Inspection, Enforcement and Standards Division on any recommendation for regulatory or adverse licensing action appropriate to the Division.

An inspector with clipboard flip


What is the IAG and how often does it meet?

The Inspection Action Group (IAG) is a non-statutory, multi-disciplinary group constituted to advise the Director of Inspection, Enforcement and Standards Division (IE&S) on any recommendation for regulatory or adverse licensing action appropriate to the Division. There are two distinct groups:

  • IAG1 considers issues related to Good Manufacturing Practice, Good Distribution Practices and Blood Establishment Authorisations (GMP/GDP/BEA) and has 24 scheduled meetings per year*, normally the first and third Tuesdays of each month.

  • IAG2 considers issues related to Good Clinical and Good Pharmacovigilance Practices (GCP/GPvP) and has 12 scheduled meetings per year*, normally the fourth Tuesday of each month.

*There may be occasions when there is not enough business to make a meeting worth while. Conversely, there have been several occasions where an urgent issue has arisen, and an emergency meeting called.

Who are the IAG?
The following attend both IAG1 and IAG2:

  • the regulatory unit manager or deputy (chair)
  • the regulatory advice manager or deputy
  • at least one medical assessor from MHRA Licensing Division
  • at least one pharmaceutical assessor from MHRA Licensing Division
  • a solicitor from DH Legal Services
  • at least one member of the IAG Secretariat
  • any inspector making a referral to the IAG
  • a representative from Enforcement Operations (if required)
  • members of MHRA staff may also attend for training purposes.

In addition, the following will attend IAG1:

  • an expert/senior GMP Inspector
  • an expert/senior GDP Inspector 
  • if required a representative from the Veterinary Medicines Directorate (external link)
  • an expert in blood and blood products (if required).

In addition, the following will attend IAG2:

  • an expert/senior GCP inspector
  • an expert/senior GPvP inspector
  • the Clinical Trials Unit manager or deputy
  • the Pharmacovigilance Risk Management Group manager or deputy.

Reasons for referral
This will usually happen if, during the inspection process, the inspector has identified one or more critical 'deficiencies' as a result of a GxP inspection. However, a referral may also be made as a result of a licence variation, the failure to contact an organisation, the refusal of an organisation to accept an inspection, the outcome of enforcement activity, the outcome of a product recall or due to an issue raised by another Member State.

The company will be informed during the closing meeting of an inspection that a referral to IAG will be made. This will be further confirmed in the post inspection letter. From that point correspondence between the company and the Agency should go via the IAG Secretariat.

How does the process work?
 

1. Inspection reveals serious (critical) deficiencies and informs company of IAG referral

2. Post-inspection letter is issued to company signed by responsible operations manager/lead inspector

3. IAG discusses the case at its next available meeting (if necessary an emergency meeting can be called)

4. IAG proposes its action to the Divisional Director for approval

5. The referred company is informed of IAG action and next steps

6. Actions are followed up at subsequent meetings until the situation is resolved

7. The matter is kept on the agenda until IAG is satisfied that the referral can be closed.

 

What are the possible actions?
IAG1 (GMP/GDP/BEA)

  • refusal to grant a licence or a variation
  • proposal to suspend the licence for a stated period
  • notification of immediate suspension of the licence for a stated period (no longer than three months)
  • proposal to revoke the licence
  • action to remove a Qualified Person/Responsible Person QP/RP from the licence
  • issue a Cease and Desist order in relation to a Blood Establishment Authorisation
  • issue a warning letter to the company/individual
  • request a written justification for actions of a QP/RP
  • referral of a QP to his/her professional body 
  • increased inspection frequency
  • request the company/individual attend a meeting at the Agency
  • refer to the Enforcement Group for further consideration.

IAG2 (GCP/GPvP)

  • issue an infringement notice in relation to a clinical trial
  • suspend or revoke a clinical trial authorisation
  • further follow-up inspections, or triggered inspections at related organisations (eg issues in GCP may trigger a GMP inspection)
  • referral to CHMP (Committee for Medicinal Products for Human Use) for consideration for against a marketing authorisation (eg suspended, varied or revoked)
  • liaison and coordinated action with EMA (European Medicines Agency) and other Member States regarding concerns
  • refer the case to the EMA for consideration of the use of the EU Infringement Regulation (which could result in a fine) 
  • request a written justification for action of a QPPV (Qualified Person responsible for pharmacovigilance)
  • request the company/individual attend a meeting at the Agency
  • refer to the Enforcement Group for further consideration.

In the case of inspections in third countries: 

  • a refusal to name a site on a marketing authorisation
  • a recommendation that a site be removed from a marketing authorisation
  • the issuing of a GMP non-compliance statement
  • in the case of an adverse (voluntary or triggered) active pharmaceutical ingredients (API) inspection, this could result in the removal of the API site from the marketing authorisation
  • in the case of an adverse (voluntary or triggered) investigational medicinal products (IMP) inspection, this could result in the suspension of a clinical trial.

In all cases, an action could result in the withdrawal of product (API, IMP medicinal product etc) from the market. This specific action is however handled by the Defective Medicines Reporting Centre (DMRC) rather than directly by IAG.

What is the legal basis for this action?

 Human Medicines Regulations 2012 (external link)
 The Medicines for Human Use (Marketing Authorisations etc) Regulations SI 1994/3144 as amended (external link)
 The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005, SI 2005/2789 (external link)
 The Medicines for Human Use (Clinical Trials) Regulations 2004 (external link)
 The Blood Safety and Quality Regulations 2005 (external link)

What can I do if referred?
In the first instance, a referral should be treated as requirement to immediately correct the deficiencies identified during the inspection and report completed actions to the IAG Secretariat/Inspectorate as soon as possible.

If the referral results in an immediate suspension of a manufacturing/wholesale dealers licence, there are no rights of appeal for the immediate suspension (which can last no longer than three months). During this time a company should be focused on correcting the inspection deficiencies.

If the referral results in a proposed suspension, variation or revocation of a licence a company will have the following appeal options prior to a decision being made:

  • may make written representations to the Licensing Authority
  • may appear before and be heard by a person appointed for the purpose by the Licensing Authority (a fee of £10,000 will be charged for a person appointed request).

If a company submits written representations the Licensing Authority shall take those representations into account before determining the matter. In practice this means that any proposed action will not be progressed until the written representations have been reviewed and considered by IAG and a recommendation made to the Divisional Director on whether to proceed with the action or not.

If a company submits a request for a Person Appointed Hearing this will be taken forward by the Panel Secretariat which sits within the MHRA Policy Division. Any proposed action will not be progressed until the Person Appointed Hearing has taken place.

It should be noted that a Person Appointed Hearing will only offer its opinion into whether a licence condition has been contravened. A final decision on whether to suspend or revoke a licence will still rest with the Licensing Authority who will take the report of the Person Appointed Hearing into account.

 

What follow up actions may be taken?

  • a re-inspection to ensure corrective actions implemented
  • request for regular updates on the corrective action plan
  • the issue of a short dated GMP certificate
  • recommended increase of inspection frequency
  • continued monitoring of the company by IAG via inspectorate updates
  • if serious and persistent non-compliance continues referral for consideration of criminal prosecution.

Contact for further information: IAGSecretariat@mhra.gsi.gov.uk


Page last modified: 21 February 2014