Regulatory Information Service (RIS) for medicines

Woman wearing a headset
Contact details
There is a single telephone number for all types of enquiry – 020 3080 7400

All enquiries relating to product licences and any associated regulatory activity should initially be referred to RIS, where the staff will endeavour to provide an answer to the enquiry and, if unable to do so, will refer to other defined areas of the Agency for an appropriate response.

NB - for regulatory advice concerning medical devices please telephone 020 3080 7300 or email ERA@mhra.gsi.gov.uk


About RIS
The RIS acts as the single main point of contact for the marketing authorisation holders of medicines and their representatives.

The RIS is manned between the hours of 8:30 and 17:30, five days a week for each day the Agency is open and can be contacted by telephone or email. The preferred method of contact concerning technical enquiries is by email, and there are addresses for different licence types:

1All enquiries relating to all types of applications for these marketing authorisations should be sent through to the corresponding mailbox, for example, all PLPI variation, label/leaflet and new licence enquiries should be sent through to the PLPI mailbox.

2The MHRA has a team to deal with queries from Marketing Authorisation Holders regarding possible errors or anomalies identified in the licence data held on our systems. If you think that you have identified an error in the data associated with your Marketing Authorisation, e-mail a detailed description of the error to this address.

For regulatory advice concerning medical devices please telephone 020 3080 7300 or email ERA@mhra.gsi.gov.uk

Email enquiries will receive an automatic acknowledgement which will be followed by an answer to the enquiry depending on its complexity.  The RIS will endeavour to answer most enquiries, however, those requiring a referral to another area of the Agency will be replied to within a given timeframe.

The RIS aims to act as a conduit for enquiries requiring input from the assessment teams, but will not act as ‘post box’ for forwarding correspondence, such as responses to Requests for Further Information (RFIs), to individuals at the request of licence holders.  These should be submitted through the correct procedural route.

Any questions about this new service can be referred to Robin Fraser, the Service Manager who can be contacted on 020 3080 7406 or by email at robin.fraser@mhra.gsi.gov.uk


Data review team
The MHRA has set-up a team to deal with queries from the marketing authorisation holders regarding possible errors or anomalies they have identified in the licence data held on our systems. If you think that you have identified an error in the data associated with your Marketing Authorisation, please send a detailed description of the error to DataReviewTeam@mhra.gsi.gov.uk


Receipt enquiries
We receive many enquiries from applicants querying whether we have received the application they recently sent to us. Typically, we will have entered the basic details of an application onto our system within around two working days of receipt of the application. At that point an acknowledgement letter is automatically sent to the applicant. On average, therefore, we would expect applicants to have received an acknowledgement letter around seven working days after the application was sent to us (this assumes first class post or courier is used and typical postal delivery times).

For Portal submissions you should have received your Intralinks email auto-receipt almost immediately. If not, please contact the Portal managers on 020 3080 7100 or via Portal.Manager@MHRA.gsi.gov.uk For other enquiries, you should quote the eight-digit Portal publication ID.

Unless there is a definite public health justification in querying whether an application has been received earlier, please do not contact us asking us to confirm receipt if less than eight working days have passed since posting your application.

If more that eight working days have elapsed and you have not received an acknowledgement letter and you wish to contact us, please use the email address Receipt.Enquiries@mhra.gsi.gov.uk  

Please note that this email address is only for use in confirming receipt of Product Licensing, Clinical Trial or Active Substance (Drug) Master File submissions which have been sent to specific Area number addresses at the MHRA’s Information Processing Unit (IPU).

The subject line should include PL number, procedure number and IPU Area number and also include the following information in the body of your email:

  • tracking number (Royal Mail or courier)
  • date of Receipt at MHRA if tracked or date of sending if not tracked
  • type of submission
  • IPU Area number to which the item was sent.

All of the above information must be included to allow us to track your applications. If you do not include this information or if you contact us before eight working days have elapsed since you sent the submission, we will not progress your enquiry.


Page last modified: 21 December 2011