Guidance

RamaXL

Published 27 January 2015

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

Its features include:

  • access to information on UK marketing authorisations
  • improved transparency of licence information
  • a powerful market intelligence tool
  • a means of managing your portfolio of products.

Rama XL assists those working in regulatory affairs, marketing, product acquisitions, business intelligence and Qualified Persons.

It is available from Monday to Thursday, 7am to 12am, Friday 7am to 7pm (UK time) and supported from 9.00am to 5.00pm (UK time) Monday to Friday.

1. Application reports

These reports are automatically delivered to you and include:

  • the status of pending applications at 6pm the previous day
  • confirmation that your fees have been paid
  • licences granted in the last month

Depending on the report, it can be delivered daily, weekly or monthly.

2. Online reports

Users can search by:

  • active substance
  • company
  • excipient
  • product name

Results can be analysed to provide information on specific products and details of formulation, packaging, pack sizes, storage conditions and shelf life.

The reports can be 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.

3. Document retrieval

For any product you can request:

  • the summary of product characteristics
  • a patient information leaflet
  • information on labelling

For your own products you can request the method of manufacture and the finished product specification.

4. Subscribe to Rama XL

You can register to use Rama XL through MHRA Portal.

After security checks have been completed we will be in touch to arrange free training sessions for your administrators and to agree a start date for the service.

5. Fees

An initial fee (excluding VAT) of £7,750 is required when you register to use RAMA XL. This will allow access to RAMA XL for 5 users per registered company. Additional 5-user packages can be purchased at any time at a cost of £6,700 per year. An annual fee of £15,500 will be charged unless registration is cancelled.

6. Contact

Enquiries relating to registration to RAMA XL, 020 3080 7100, portal.manager@mhra.gov.uk