This page contains information for pharmaceutical organisations about the X-PIL service.
What is X-PIL for?
The X-PIL service makes Patient Information Leaflets or "PILs" supplied with UK medicines accessible to blind and partially sighted people.
Leaflet formats covered by the X-PIL service include large print, audio CD and braille produced by RNIB. Customers can also listen to PILs over the phone.
The X-PIL service was also developed to help companies meet their legal obligations under EU Council Directive 2004/27/EC-Article 56(a).
Please note that CEN/TR 15753:2008 Packaging - Package leaflets for medicinal products - Braille and other formats for visually impaired people is now available from National Standards Bodies. This report gives helpful advice on practical aspects of producing accessible format versions of patient information leaflets.
How does it work for the customer?
For your customer the service is fairly simple to use. They can request their PIL in alternative formats (braille, large font and audio CD) by telephoning the RNIB Medicine Leaflet Line on 0800 198 5000.
Or for instant access, they can also choose to listen to their PIL when they call the RNIB Medicine Leaflet Line.
We ask the customer to quote the Product Licence (PL) number so we can identify the PIL they are looking for. Unfortunately this can be difficult to access when it's in small print so some assistance may be needed. We also suggest this PL number is printed on the PIL in a section where the X-PIL phone number is given. Ideally the PL and X-PIL phone number should be printed in a large font size.
How does it work for the company?
The X-PIL service is run as a 12 month membership from the date you join.
There are three membership options available. Options 1 and 2 are available to Datapharm members only, because of the method of storing the PILs. Option 3 is available to any company.
Option 1 - Datapharm members only
Overview
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Only available to Datapharm members.
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On joining Option 1 you commit to all your PILs being available in alternative formats as soon as is operationally feasible.
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If you want to commit all your products, but over an extended period of time, you must sign up via Option 2.
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You must approve the HTML rendition of the PIL and ensure it is the most recent version approved by the regulatory authority.
Benefits
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Lower fee per PIL as you will be signing up all of your PILs to the service, ensuring maximum accessibility for your customers.
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The £160 plus VAT fee covers unlimited requests for your PIL in all three alternative formats.
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There is no additional charge if the content of any of your PILs requires updating or amending.
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If submitted, your PILs can be made available on the X-PIL website. This will enable your customers to access PILs using access technology.
Fee
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The fee is £160 plus VAT per product PIL for 12 months membership.
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You must sign up all of your PILs for Option 1 membership.
Option 2 - Datapharm members only
Overview
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Only available to Datapharm members.
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You must approve the HTML rendition of the PIL and ensure it is the most recent version approved by the regulatory authority.
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Please note that any additional PILs requested above your initial commitment will be processed at a fee of £360 plus VAT. You will then be given the option whether to add that PIL to your Option 2 membership or to upgrade to Option 1 membership.
Benefits
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The flexibility to sign up PILS on an ad-hoc basis.
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For some companies this may be a more cost effective option.
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Option of upgrading your membership to Option 1 at any time.
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If submitted, your PILs can be made available on the X-PIL website. This will enable your customers to access PILs using access technology.
Fee
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The fee is £720 plus VAT per for 12 months membership. This payment will cover two product PILs.
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Additional PILs may be added at £360 plus VAT per PIL.
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The fee covers unlimited requests for your PIL in all three alternative formats.
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There is no additional charge if the content of any of your PILs requires updating or amending
Option 3 - for any company
Overview
This is the only option available to non-Datapharm members.
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You must approve the HTML rendition of the PIL and ensure it is the most recent version approved by the regulatory authority.
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Your PILs will not be available online via the X-PIL website.
Benefits
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Your customers will use the RNIB Medicines Leaflet Line to request alternative formats, as for Datapharm member PILs.
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The flexibility to sign up PILs on an 'ad-hoc' basis. RNIB will undertake QC as defined within the RNIB / company agreement
Fee
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The fee is £720 plus VAT per for 12 months membership. This payment will cover two product PILs.
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Additional PILs may be added at £360 plus VAT per PIL.
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The fee covers unlimited requests for your PIL in all three alternative formats.
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You will be charged an additional £360 plus VAT if the version of the PIL held requires update or amendment by RNIB.
Companies in the Republic of Ireland
We have a solution for companies in the Republic of Ireland, which is similar to Option 3 membership for UK based X-PIL. For details of the process and pricing, please contact us on 01733 37 53 70.
What next?
If you have any questions about the X-PIL service or which membership is right for you, call us on 01733 37 53 70 and we'll talk through the options with you..
Contact us
RNIB Disability Access Services
PO Box 173
Peterborough
PE2 6WS
Tel: 01733 37 53 70
Email: businesslink@rnib.org.uk