RamaXL

RamaXL is a subscription service providing subscribing organisations with direct access to real-time information on their own products and non-confidential information on all other products authorised in the UK

Sentinel
RamaXL provides subscribers with remote access to the MHRA's main system, Sentinel, which is the only official source of information on medicinal products authorised for use in the UK.

Sentinel is the Agency’s new database for processing applications relating to medicines and comprises a structured database storing information such as actives, pack sizes etc., linked into a document management system that stores the Summary of Product Characteristics (SmPCs), leaflets and labels together with supporting data. It is an integrated and sophisticated set of tools for data entry, information and document retrieval, common dictionaries, workflow and processing tools across the range of medicines licensing. Applications can be made via a secure electronic portal and letters and approvals can be sent back to the company via this portal. It provides the MHRA with a transformational way of doing business an enables it to work electronically with all its medicines stakeholders.

RamaXL
RamaXL replaces the old RAMA service and is delivered through the MHRA portal and there is a charge for this subscription service.

RamaXL's principal features and benefits include:

• the provision of information on subscribers' own products and non-confidential information on all granted and gazetted products
• access to a single official repository of information on UK marketing authorisations (MAs) 
• improved transparency of licence information
• secure access to information from any web-enabled PC.

Combined with your own knowledge it provides a powerful market intelligence tool as well as a means of assisting in managing your portfolio of products. The information available assists those working in regulatory affairs, marketing, product acquisitions, business intelligence and Qualified Persons.

RamaXL in operation
RamaXL is delivered through the MHRA’s secure portal provided by Intralinks Inc. and is available from Monday to Thursday 7.00am to 12.00am, Friday 7.00am to 7.00pm (UK time) and supported from 08.30 to 18.30 (UK time) Monday to Friday. The RamaXL subscription service provides a number of ways of accessing the information on Sentinel.

• Regular reports

These reports are automatically delivered to your workspace and reflect the status of your pending applications as at 6pm the previous day. You can chose to have these reports refreshed daily, weekly or monthly but most existing subscribers have them refreshed daily. These reports will tell you what stage you application has reached, whether the system records you fees as being paid, which licences have been granted in the past month etc.

• On Line reports

These reports are real time enquiries to from the Sentinel database and are accessed using Business Objects. In addition to real time versions of the regular reports, users can query by active substance, company, excipient, product name etc. The query returns results which can then be drilled into to provide more information on specific products and you can see details of the formulation (qualitative information only for products which are not yours), packaging, pack sizes, storage conditions, shelf life etc. and can order documents relating to those products. The reports can be further filtered and the results saved into Excel for further processing if required. For your own products you are also able to see the product’s history and details of all the companies associated with the product.

• Document retrieval

For any product, including those returned as a result of your online query, you can request a number of documents: the SmPC, patient information leaflet and labelling for all products and, additionally for your own Products the method of manufacture and the finished product specification.

How to subscribe
All that is required to use the Portal is an internet enabled PC with Broadband connection and Adobe Reader 7.0.5 to 8.1.0 (available for free download from the Adobe website). To the registration form must be completed using these versions of Adobe Reader and is available at https://portal.mhra.gov.uk. Our Portal and RamaXL helpdesk team are available to assist on +44 (0)20 7084 3100. After completion of our security checks we will be in touch to arrange for the free training sessions for your administrators and to agree a “start” date for the service.

Costs of subscribing
The costs of subscribing to RamaXL are an initial fee of £7,750 and an annual fee of £15,500 for 5 users. Additional “bundles” of 5 users can be purchased at any time at a cost of £6,700 per year.

Contact for further information
For further information about RamaXL and if you would like a demonstration of the service, please contact Frances Law on 020 7084 2372, e-mail frances.law@mhra.gsi.gov.uk. Demonstrations are given at our offices in London or by a videolink/weblink and last between one and two hours.