Moving toward paperless communication
An introduction to the MHRA Sentinel eComms project
What is the Agency changing?
When trade organisations were consulted in 2015 about how the MHRA could
improve the service it provides, they requested paperless communication as a
priority. Customers too have asked why they submit CESP applications
electronically via a portal but receive a paper letter in response.
In the future, all Agency communications will be paperless by default, until then the
Sentinel eCommunications project will provide a tactical solution that will deliver
paperless communications for CESP submissions in Autumn 2016.
It will mean:
 Less paperwork for customers
 Faster results for customers (no waiting for the post)
 The Agency is transforming the way technology supports its work.
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A consultative approach
The Agency invited trade organisations to a working group to help shape the
solution and provide feedback on the initiative. Seven trade representatives met on
22 June – representatives from ABPI, PAGB and EMIG.
The working group has been set up to shape the solution and provide feedback on
the initiative:
 To contribute ideas and opinions to support the delivery of the solution.
 To communicate the Sentinel e-communications solution with colleagues and
report back to trade association groups
 To be involved in testing the solution to ensure successful delivery from a
customer perspective.
NB. This is a tactical solution to streamline the process while the Agency builds
new systems.
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The proposed solution
The solution will send all communications from the agency’s Sentinel system in relation
to product licensing and master files by email to a single email address for each
customer.
The agency will need to request a single email point of contact from customers.
The emails will be unique and distinctive from any other MHRA email communications.
Below is a suggested format.
From : [email protected]
To : [email protected]
Subject :PL 99000/1234 – 0012 Acknowledgement Notification
Mail body: Please find the attached communications for the <Application Name> case folder
<Casereferenceid>.
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Collecting contact email addresses
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•
It is vital to collect an email address contact from all customers.
•
An initial letter will be sent to all customers in the week commencing 30 June.
Following that, a number of reminders will be sent, asking customers to send us
a contact email addresses.
•
MHRA proposes that companies use a generic email address that will be a
central contact for a Marketing Authorisation Holder.
•
Although contacts will change, it is not envisaged that the email address will
change regularly with each submission.
The case for a central email address
Advantages of using a central email address per organisation
 All communications will go to one place making it easier track this
information
 If a member of staff is on holiday, sick or leaves the organisation,
communications won’t be ‘stuck’ in their mailbox
 All necessary staff can access this information at any time and are
not reliant on members of the team to pass this information on
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Frequently asked questions
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FAQ
If you have any questions that aren’t answered in this document, please share them with the relevant
member of the working group (you can find out who this is at the back of the document.
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Question
Answer
What is Sentinel?
Sentinel is the name of the current MHRA systems that were implemented to meet the
information needs of the agency..
What is CESP?
CESP is the Common European Submission Portal. This provides a secure method of
submitting applications with the Regulatory Agencies via one platform.
What communications does the ecomms change apply to?
The e-comms solution will apply to communications involving product licensing and master
file submissions sent via CESP. Specifically, in scope are communications associated with
new MA applications, MA variations, RFI letters, Renewals, and PLPI submission of all types.
The solution will not change the way in which the MHRA portal communications are delivered
or any other types of submissions or communications.
Can customers ask for emails to go
to numerous email addresses?
The agency require one contact email address per legal entity. We are not able to hold
multiple email addresses per organisation or send letters to multiple email addresses.
How will e-comms affect the portal
customers?
The e-comms solution is targeted at CESP users and will replace the current paper letters
these users receive with an email. There is no change to how the MHRA portal functions
and Portal users will continue to receive the same in-built electronic communications as they
currently receive.
How soon after submitting a
notification can I expect to hear
back from the Agency? Can I
expect to receive decisions faster
as a result of this change?
The e-comms solution is changing the way in which the agency sends letters. It will not have
an impact on how we process submissions or on our processing times so you should expect
similar decision times to those you currently see. The decision letter will however be emailed
to you soon after the decision so the e-comms solution will remove the time taken by the
postal system to deliver paper letters.
Project working group members (external
to MHRA)
Paul Moran – Broughton Laboratories (PAGB)
Archana Gnana Sekhanan - Genesis Pharmaceuticals (PAGB)
Angela Walker - LEO Pharma (ABPI)
Dafyeld Taylor (PAGB)
Kamran Salim - Pfizer Ltd (ABPI)
Lucy Herlihy – Real Regulatory (EMIG)
Sunayana Shah (ABPI)
Emma Jones Hele,n Marshall – Janssen Cilag Ltd (ABPI)
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