Background

The MHRA Pharmacovigilance Inspectorate is part of the Inspections and Standards Division of the MHRA. It assesses pharmaceutical companies’ compliance with UK and EU legislation relating to the monitoring of the safety of medicines given to patients.


It is one of the five inspectorates at the MHRA. The other four being:

  • Good Clinical Practice (GCP) Inspectorate
  • Good Distribution Practice (GDP) Inspectorate
  • Good Laboratory Practice (GLP) Inspectorate
  • Good Manufacturing Practice (GMP) Inspectorate

In this section you will find information regarding the working of the group, its responsibilities and powers as well as details of the inspection process.  We have presented the information in an easy to follow question and answer format but if you require any further information please do not hesitate to contact us.

Additional post-authorisation guidance is available on the EMA website (external link).

What is pharmacovigilance?
Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medicines, biological products, herbals and traditional medicines with a view to:

  • Identifying information about potential new hazards
  • Preventing harm to patients.

The word is derived from the Greek pharmakon - drug, and the Latin vigilare - to be awake or alert, to keep watch.


What is the MHRA Pharmacovigilance Inspectorate Unit?
By conducting inspections at the sites of marketing authorisation holders, Pharmacovigilance Inspectors assess compliance with the requirements of legislation and guidelines relating to the monitoring of the safety of medicines used in clinical practice. Each Inspector has a statutory duty to assess compliance with medicines legislation and holds a warrant accordingly.


What does the Unit do?
The function of the Pharmacovigilance Inspectorate is to assess pharmaceutical companies’ compliance with UK and EU legislation relating to the monitoring of the safety of medicines given to patients. This is mainly achieved through carrying out inspections of UK Marketing Authorisation Holders (MAHs). These are the persons or organisations responsible for placing medicinal products on the market, usually pharmaceutical companies.
 

What rights do inspectors have?
Inspectors have rights conferred under the Medicines Act 1968 sections 111(1 to 3) and 112 (1 to 4 and 7) as well as subordinate legislation applying the Act. These include the right to enter any premises covered by the Act to carry out inspections, take samples, require the production of books and documents, and to take copies of, or copies of entries in, such books and document and seize and detain substances, articles and documents. It is a criminal offence under section 114 (2 and 3) of the Medicines Act 1968 to obstruct an Inspector during the conduct of an inspection covered by the Act.


How is the inspectorate organised?
An organogram for the Pharmacovigilance Inspection Unit is available below:
› Organogram for the Pharmacovigilance Inspectorate UnitPDF file (opens in new window) (364Kb)


Who does the unit report to?
The Inspectorate reports to Gerald Heddell, Director of the Inspection and Standards (I&S) Division.

Mr Heddell is a member of the MHRA’s Executive Board which reports to Department of Health Ministers via the MHRA’s Agency Board.


Where is the unit located?
The unit operates from two locations:

  1. Pharmacovigilance Inspectorate Unit, MHRA, 2 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW, telephone 01707 299130, fax 01707 376649
  2. Pharmacovigilance Inspectorate Unit, MHRA, Market Towers, 1 Nine Elms Lane, London, SW8 5NQ, telephone 020 7084 2606, fax 020 7084 3519


Fees
Organisations who are Marketing Authorisation Holders (MAHs) are charged a fee when they undergo pharmacovigilance inspections. From 1 April 2008 the fee structure for inspections has changed to a fee calculated on the basis of the time inspectors spend on site – a daily fee. The daily fee rate was part of this year’s fees consultation (MLX 344).

The current level of fees payable and additional information on how the fees will be calculated can be found in our 'Fees for licensing medicines' section.

Organisations that are not MAHs, but are involved in drug development and hold a clinical trial authorisation (CTA) are not currently subject to pharmacovigilance inspections. However, they are subject to Good Clinical Practice (GCP) Inspections.


Links
(The MHRA is not responsible for the content of external internet sites)

 

Contact for further information
For further information on this part of our site, please contact either:

  1. Pharmacovigilance Inspectorate Unit, MHRA, Market Towers, 1 Nine Elms Lane, London, SW8 5NQ, telephone 020 7084 2606, fax 020 7084 3519  or e-mail info@mhra.gsi.gov.uk
  2. Pharmacovigilance Inspectorate Unit, MHRA, 2 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW, telephone 01707 299130, fax 01707 376649 or e-mail info@mhra.gsi.gov.uk


Page last modified: 26 November 2011