Our new Sentinel information management programme, which covers all areas of the Agency’s core medicines business, has been designed to transform the Agency’s capabilities and leverage the current industry trends to full electronic workflow for regulatory submissions. At the centre of this design is the ability to receive submissions electronically via a secure external portal.



Access the MHRA Portal

We are pleased to announce that the MHRA Portal is now available and all product licence applicants can take advantage of its ability to provide a secure means of communicating with the MHRA electronically. It enables you to submit applications and responses and for us to send you communications.

Historical data does not need to be re-submitted electronically. As part of the Sentinel programme, the Agency has scanned some 28 million pages of historical paper-based information into its systems. This means that the Portal can be used for new applications and variations alike.

In the case of product licensing, the Portal uses 'smart' application forms. These allow you to check the data, at the point of entering it into the form, which removes the potential for errors which would have to be returned. The data that is entered onto the forms is uploaded directly into our database.

At the moment, the 'smart' application forms are limited to product licensing but we are working to extend these forms to other areas in the future.

Accessing the Portal
The Portal can be accessed from any internet-enabled PC. In order to connect to the MHRA Portal you will need the following:

  • PC with broadband internet access
  • Adobe Reader version 7.0.5, 8.1.0 and 9.0. The intelligent forms are not currently accessible with versions higher than 9.0 Reader. (Adobe - Adobe Reader download – Other versions [external link])
  • cookies need to be enabled.

Supported web browsers:

  • Internet Explorer version 6.0, 7.0, and 8.0
  • Firefox version 3.0
  • Safari version 3.1

Information about changes for browser support

As of October 1, 2008, IntraLinks will no longer support Netscape, versions of Internet Explorer earlier than 6.0 or any version of Internet Explorer for the Macintosh operating system.

You can continue to use earlier versions of Internet Explorer to access IntraLinks, but you may not be able to use some IntraLinks features.

You or your systems administrator can download and install a browser that is supported by IntraLinks. Internet Explorer version 6.0 or higher is available from Microsoft. Firefox version 2.0 is available from Mozilla. Safari version 3.1 is available from Apple. These browsers can be downloaded free of charge.

To register for the Portal please use the Portal website link and guidance notes Powerpoint file (opens in new window) (1627Kb). You should also be aware of the following considerations.

  • The Portal requires you to name two administrators of the system who will be solely responsible for managing your users. It is therefore important that you select these staff carefully and put in place the necessary procedures to provide appropriate levels of security for your company.
  • There is no charge for the two administrators and for five other Portal users. Should you require additional users you may buy additional bundles of five users at a cost of £1,000 per bundle. Please note that all costs are exclusive of VAT.
  • Only the registered company director(s) can agree to the terms and conditions on behalf of each of the companies in the group for the Portal. These need to be signed and a hard copy returned to MHRA.
  • Before access is permitted, both administrators must attend a half day’s training at the MHRA.

Training dates 2010*

June 10, 24
July 8, 22
August 5, 19
September 2, 16, 30
October 14, 28
November  11, 25 
December 9, 23

* Dates may need to be changed

Current versions of forms on the Portal (March 2009)

Forms New version number
Administration Workspace 04
eSubmissions Workspace  
Marketing Authorisation Application 08
Change of Ownership 05
General Product Licensing Submission 04
Herbal and Homeopathic Registration 04
Information Submission 04
Master File Application 04
PLPI Application 07
Renewal Application 07
Variation Application 06
Certificate of Manufacturing Status Application 03
Certificate of a Pharmaceutical Product Application 04
Number Allocation 04
Document Retrieval Form 03

Contact for further information
For information on receiving ASPRs via the portal, please visit the Anonymised Single Patient Reports section of the website or email Pharmacovigilanceservice@mhra.gsi.gov.uk

Page last modified: 14 June 2010