The Inspection Action Groups (IAG) are non-statutory, multi-disciplinary groups which advise the Medicines and Healthcare products Regulatory Agency’s (MHRA) director of inspection, enforcement and standards on recommendations for regulatory or adverse licensing action.
Role of the group
There are 2 IAGs:
- IAG1 has 24 scheduled meetings a year, normally the first and third Tuesday of each month, and considers issues related to:
- good manufacturing practice (GMP)
- good distribution practice (GDP)
- blood establishment authorisations (BEAs)
- IAG2 has 12 scheduled meetings per year, normally the fourth Tuesday of each month, and considers issues related to
- good clinical practice (GCP)
- good pharmacovigilance practice (GPvP)
On some occasions, scheduled meetings may not take place if there is not enough business. If an urgent issue comes up an emergency meeting can be called or the issue can be dealt with by email circulation.
Reasons for referral
This will usually happen if, during the inspection process, the inspector has identified 1 or more critical deficiencies.
A referral may also be made:
- as a result of a licence variation
- if we are unable to contact an organisation to arrange an inspection
- if an organisation refuses to accept an inspection
- as an outcome of enforcement activity
- as the result of a product recall
- due to an issue raised by another EU member state
The company will be informed during the closing meeting of an inspection that they will be referred to IAG and this will be confirmed in the post-inspection letter. From that point all correspondence between the company and the agency should go via the IAG secretariat.
View our guidance on what can happen if you are referred to IAG (PDF, 81.2KB, 3 pages) .
The following attend both IAG1 and IAG2:
- the regulatory unit manager or deputy (chair)
- at least 1 medical assessor from MHRA Licensing Division
- at least 1 pharmaceutical assessor from MHRA Licensing Division
- a solicitor from Department of Health Legal Services
- at least 1 member of the IAG secretariat
- any inspector making a referral to the IAG
- a representative from MHRA enforcement
- 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
- 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