Inspection Action Groups
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 two IAGs:
IAG1: Meets approximately twice per month (24 times/year)
Covers:
- Good Manufacturing Practice (“GMP”)
- Good Distribution Practice (“GDP”)
- Blood Establishment Authorisations (“BEAs”)
IAG2: Meets approximately once per month (12 times/year)
Covers:
- Good Clinical Practice (“GCP”)
- Good Pharmacovigilance Practice (“GPvP”)
Meetings will be cancelled if there is not enough business for discussion. Urgent matters will prompt emergency meetings or email resolution.
Reasons for Referral
Referrals typically occur following inspections which identify critical deficiencies.
Other reasons include:
- Licence variations
- Inability to arrange inspections
- Inspection refusals
- Criminal Enforcement Unit outcomes
- Product recalls
- Concerns raised by other Regulators
Companies are notified at the inspection closing meeting and in the post-inspection letter (IAG1 cases) or critical findings letter (IAG2 cases), that they will be referred to IAG. From then, all correspondence is handled via the secretariat.
View our guidance on .
Members
Attendees for both IAG1 and IAG2 include:
- Head of Regulatory Governance (Chair)
- MHRA medical and pharmaceutical assessors
- Referring inspector(s)
- Additional MHRA staff (for training)
IAG1-specific attendees:
- Senior GMP/GDP inspectors
- Blood product experts (if required)
- Veterinary Medicines Directorate representative (if required)
- Department of Health and Social Care representative (if required)
IAG2-specific attendees:
- Senior GCP/GPvP inspectors
- Clinical Investigations and Trials representative
- Safety and Surveillance representative
Suspended and Revoked List
A list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients suspended or revoked can be found here: Suspended and Revoked List
Contact
IAG2Secretariat@mhra.gov.uk