This section provides details of the MHRA's Central Enquiry Point.
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During February we are conducting a survey of the service we offer through the Central Enquiry Point. We endeavour to provide a friendly and informative customer focused service in line with the standards outlined below. The purpose of the survey is to establish how our customers feel about the service, and where they’d like to see developments made. A link to the survey is included below; alternatively you can take the survey over the telephone by contacting us on 020 3080 6000. Your feedback is critical in enabling us to identify where and in what ways our customers would like to see the service develop. Summary results from the survey will be posted on this page in early April. Central Enquiry Point Survey (external link) |
About the Central Enquiry Point
The Central Enquiry Point is the main contact point for the Agency, providing a dedicated phone line and email enquiry service to all our stakeholders. We are open between 9:00 and 17:00 every working day and strive to open three telephone lines during peak times to meet the demands on our service.
We are the first point of contact for enquirers approaching the MHRA, including those with general enquiries and those who are unsure which units they need to speak to. You may find the alternative contact points listed below helpful for directing your enquiry, together with the specific enquiries by subject section of our website.
However if you are unsure, please contact the Central Enquiry Point Team who will advise you and may refer your enquiry to the appropriate area of the agency.
T: 0203 080 6000
E: info@mhra.gsi.gov.uk
Standards of service you can expect from the Central Enquiry Point
The CEP receives 1,000 phone call and email enquiries every week, of which half are responded to directly by the Central Enquiry Point. The way we handle each enquiry depends on the nature and complexity of the request, and although most units work to the Department of Health’s target of 20 working days, please be aware that some work to slightly longer timeframes.
- Simple phone calls will either be answered immediately by the Central Enquiry Point staff, or transferred to the appropriate person or area within the Agency.
- Simple emails will be answered by the Central Enquiry Point team within 1-5 working days, depending on their nature.
- Complex/specific enquiries are passed on to the relevant agency expert or unit to provide a response, within the targets of that area. It should be noted that some areas require complex enquiries to be submitted by email (usually to a dedicated email address, which the Central Enquiry Point Team can provide).
- Database requests are enquiries that require our Information Scientists to retrieve medicines information from our licensing database, ‘Sentinel’. Such queries must be submitted in writing (email, fax or letter) which ensures we are clear on the information being requested. Around 60 medicines information requests are received each week and all are logged, acknowledged and then answered in order of receipt and within 20 working days.
- Freedom of Information Act requests must be submitted in writing. Each request will be sent an acknowledgement confirming the reference number and advising that a reply should be sent within 20 working days of receipt. Please review the Freedom of Information section of our website for further information.
Pharmaceutical industry enquiries
These enquiries are usually handled by one of the Agency’s industry helpdesks who manage enquiries from licence holders and their representatives:
- The Regulatory Information Service (RIS) Helpdesk for enquiries relating to product licences (marketing authorisations) and any associated regulatory activity.
- The Pharmacovigilance Service Desk for enquiries about any pharmacovigilance related matters.
- The Process Licensing (PcL) Enquiry Team for enquiries from manufacturing and wholesale dealer licence holders and their representatives about the administrative activities associated with issuing and maintaining manufacturer's and wholesale dealer's licences: PcL@mhra.gsi.gov.uk or 020 3080 6844.
- The Submissions Centre for enquiries about the submission requirements detailed in the document ‘Special MAIL 5’ and the associated frequently asked questions publication. Enquiries should be submitted after reading the frequently asked questions publication, quoting the work-type area number listed in Special MAIL 5 in the subject line: Submissions.Centre@mhra.gsi.gov.uk
- The Portal Helpdesk for enquiries about registering and electronically submitting product licence applications via the secure external MHRA Portal - portal.manager@mhra.gsi.gov.uk or 020 3080 7100.
Device industry enquiries
- Enquiries relating to regulatory advice concerning medical devices are handled by the Devices Policy, European & Regulatory Affairs (DPERA) Team - era@mhra.gsi.gov.uk or 020 3080 7300.
- Enquiries relating to the safety, quality and performance of specific medical devices are handled by the appropriate device specialist(s), as identified in the specific enquiries by subject section of our website.
- The Devices division handles requests for technical and safety guidance and publications concerning medical devices - dts@mhra.gsi.gov.uk or 020 3080 7272.
- The Adverse Incident Centre (AIC) is responsible for the Adverse Incident Reporting Hotline and for the receipt and processing of reports of adverse incidents involving medical devices and equipment - AIC@mhra.gsi.gov.uk 020 3080 7080.
Blood safety and quality enquiries
- The SABRE haemovigilance team is responsible for handling reports of serious adverse reactions and events involving blood or blood components for transfusion - sabre@mhra.gsi.gov.uk or 020 3080 7336.
