Regulatory Information Service (RIS) for medicines

Telephone - 020 7084 3400

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 08:30 and 17:30, five days a week for each day the Agency is open and can be contacted by telephone or e-mail.

There is a single telephone number for all types of enquiry – 020 7084 3400

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 7084 3300 or e-mail ERA@mhra.gsi.gov.uk

The preferred method of contact concerning technical enquiries is by e-mail and there are addresses for different licence types :-

*All 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.

For regulatory advice concerning medical devices please telephone 020 7084 3300 or e-mail ERA@mhra.gsi.gov.uk

E-mail 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 7084 3406 or by e-mail at robin.fraser@mhra.gsi.gov.uk.


Page last modified: 22 May 2007