Comply with good pharmacovigilance practice, complete a compliance report and prepare for an inspection.

Overview

Good pharmacovigilance practice (GPvP) is the minimum standard for monitoring the safety of medicines on sale to the public in the EU.

MHRA inspects marketing authorisation holders and their contractors, to ensure they:

  • have an adequate and effective quality system for monitoring the medicines they have licences for
  • maintain a pharmacovigilance system master file
  • document all actions they take
  • have enough competent, appropriately qualified and trained staff to work the system

Types of inspection

Routine national inspections under the risk-based compliance programme

Every marketing authorisation holder’s site has a risk rating and we prioritise inspections for those with the highest scores. You will usually be notified of these inspections in advance. The inspections are generally systems-based.

EU inspections

EU inspections of marketing authorisation holders with centrally authorised products are carried out in accordance with the 4-year EU inspection plan, adopted by the Committee on Human Medicinal Products (CHMP) and are usually conducted as routine national inspections.

Triggered inspections

MHRA may inspect you if we’re informed about possible GPvP breaches by:

  • a whistleblower
  • other MHRA departments
  • another regulatory authority

Triggered EU inspections of marketing authorisation holders may also be requested by the Committee on Human Medicinal Products (CHMP).

We may send little or no notification of these inspections in advance.

Occasionally, non-UK sites may be inspected if they are involved in pharmacovigilance activities for medicines marketed in the UK/EU.

Prepare for a GPvP inspection

We’ll send you a preliminary notification of statutory inspection, requesting either the:

  • Summary of Pharmacovigilance Systems (SPS)
  • Pharmacovigilance System Master File (PSMF)
  • Detailed Description of Pharmacovigilance Systems (DDPS)

You must acknowledge that you have received the notification and provide details of the relevant contact person for future correspondence about the inspection.

If you have concerns about the authenticity of a notification, contact gpvpinspectors@mhra.gsi.gov.uk.

If you have transitioned to the Pharmacovigilance System Master File (PSMF), and formally introduced the Pharmacovigilance System Summary (PSS) to any of your authorisations, the PSMF should be submitted to MHRA instead of the SPS.

Until 2015, if you have not yet transitioned to the PSMF, you must submit either:

  • an SPS
  • a current DDPS, supplemented with the additional information requested in the SPS (as described in the SPS guidance notes).

SPS template (MS Word Document, 194KB)

Guidance notes on the information requested for an MHRA statutory pharmacovigilance inspection (PDF, 67.4KB, 12 pages)

Once you supply the SPS/PSMF/DDPS to us, we agree an inspection date with you.

The inspection team may ask for additional documentation prior to, during or after the inspection.

The inspection

During an inspection the inspection team will:

  • conduct site visits
  • interview relevant personnel
  • review documents
  • carry out computer system reviews including searching pharmacovigilance databases

The inspection team may ask for additional documentation during the inspection. They may also change the focus of the inspection if they suspect serious non-compliance.

At the closing meeting the inspector will provide feedback and discuss any deficiencies and actions required after the inspection with you.

Grading of inspection findings

Deficiencies found during inspections are graded at 3 levels.

Critical

A critical deficiency in pharmacovigilance systems, practices or processes is one that either:

  • adversely affects the rights, safety or wellbeing of patients
  • poses a potential risk to public health
  • is a serious violation of legislation and guidelines

Major

A major deficiency could potentially either:

  • adversely affect the rights, safety or wellbeing of patients
  • pose a risk to public health
  • represent a violation of legislation and guidelines

Minor

This type of deficiency would not be expected to adversely affect the rights, safety or wellbeing of patients.

Common inspection findings and inspections post-July 2012 (MS Powerpoint Presentation, 857KB)

Actions after the inspection

After the inspection closing meeting, you will receive an inspection report confirming any deficiencies found.

The report only includes things that the inspection team sees and hears during the inspection. It does not mean everything is fine with areas not looked at during the inspection.

You must respond to the inspector by email to confirm the Corrective Action, Preventative Action (CAPA) plan. The inspector will review your response, which must be approved by your qualified person for pharmacovigilance (QPPV).

You need to give responses to inspection findings within 25 working days of the report being issued.

Responding to inspection findings (MS Powerpoint Presentation, 790KB)

Once the CAPA is accepted, we send an inspection closing letter.

If findings are referred to the Pharmacovigilance Inspection Action Group (PIAG), non-routine post-inspection actions may be taken in addition to the review of the CAPA and the provision of a closing letter.

Infringement notices

An infringement notice may be issued when instances of serious or serious and persistent non-compliance with pharmacovigilance requirements have been identified.

Below are all the companies who have been issued an infringement notice.

Company name Date issued Reason Infringement notice Status
Omega Pharma Limited 9 October 2013 Regulatory action Infringement notice Closed: MHRA has confirmed that the measure set out in the infringement notice have been implemented successfully

Legislation and further guidance

UK Human Medicines Regulations, Statutory Instrument 2012 No. 1916, Part 11

Directive 2001/83/EC as amended

Regulation (EU) No. 726/2004 as amended

Commission Implementing Regulation (EU) No. 520/2012.

Good pharmacovigilance practice modules

Volume 9A of The Rules Governing Medicinal Products in the European Union, September 2008

The process for pharmacovigilance inspections is described in the Guideline on good pharmacovigilance practices (GVP) Module III (Pharmacovigilance inspections).

Contact

Pharmacovigilance Inspectorate Unit
MHRA
5 Yellow
151 Buckingham Palace Road
London
SW1W 9SZ

020 3080 6000