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Central Enquiry Point

MHRA Regional Offices

Standards of service you can expect from the Central Enquiry Point (CEP)
The CEP receives nearly 1,000 phone call and e-mail enquiries every week and the way we respond to these depends on the nature and complexity of each request:

• Simple phone calls will either be answered immediately by the CEP staff, or transferred to the appropriate person or area within the Agency.
• Simple e-mails will either be answered by the CEP staff within 48 hours, or transferred to the appropriate person or area within the Agency to provide a response within the targets of that area. 
• Complex/specific enquiries are passed on to the relevant agency expert or area to provide a response within the targets of that area. It should be noted that some areas require complex enquiries to be submitted by e-mail (usually to a dedicated e-mail address, which the CEP 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 (e-mail, 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 requests must be submitted in writing, each request will be sent an acknowledgement confirming their reference number and advising that a reply should be sent within 20 working days of receipt.

Please note that timeframes for response throughout the Agency vary between areas, but most work to the Department of Health’s target of 20 working days.

You may find the following alternative contact points helpful for directing your enquiry, together with the ‘Specific enquiries by subject’ section of our website. However if you are unsure, please contact the CEP Team who will endeavour to transfer your enquiry to the appropriate area of the agency.

Pharmaceutical industry 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 tel: 020 7084 2844. 
• 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 Tel: 20 7084 3100.

Device industry enquiries

• Enquiries relating to regulatory advice concerning medical devices are handled by the Devices Policy, European & Regulatory Affairs (ERA) Team: ERA@mhra.gsi.gov.uk or tel: 020 7084 3300.
• 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 Device, Technology and Safety (DTS) Services team handle requests for technical and safety guidance and publications concerning medical devices: DTS@mhra.gsi.gov.uk or tel: 020 7084 3272. 
• 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 or tel: 020 7084 3080.

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 Tel: 020 7084 3336.

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