MHRA Portal enables all product licence applicants to take advantage of a secure means of communicating with the MHRA electronically. Allowing you to submit applications and responses and for us to send you communications.
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.
Accessing the Portal
The Portal can be accessed using the following browsers:
- Internet Explorer version 6.0, 7.0, 8.0 and 9.0
- Firefox version 7.0
- Safari version 5.1
- Chrome version V14+
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 7.0 is available from Mozilla. Safari version 5.1 is available from Apple. Google Chrome V14 is available from Google.
To register for the Portal please use the Portal website link and guidance notes
(441Kb). 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 2013*
| January | 24 |
| February | 14 |
| March | 14 |
| April | 11 |
| May | 16 |
| June | 13 |
| July | 18 |
| August | 15 |
* Dates may need to be changed
NB Portal training will be organised once all Portal paperwork has been completed and the Portal Manager has given the go-ahead to the Portal Training Team. Training dates are allocated on a first come first serve basis, with a limited amount of places per session. It is therefore possible that the published training dates are no longer available and you will need to negotiate a suitable date with the Portal Training Team.
Current versions of forms on the Portal (January 2013)
| 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 |
| RamaXL | |
| 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
