MHRA's 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.

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 V 7.0.5 or higher (available for free download from the Adobe website).

-- Cookies need to be enabled.

To register for the portal please use the link https://portal.mhra. 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.

-- A company director(s) needs to agree the terms and cConditions 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.

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