• SPC, PIL and Labelling Texts
• Artwork Creation
• Readability Testing

Good quality product literature is one of the keys to successful regulatory approval and attention to detail is important in writing the Summaries of Product Characteristics, Patient Information Leaflets and labelling texts. Wainwright Associates can advise on the regulatory requirements for both content and format under EU legislation as well as write or review the relevant texts.

Creation of the final artwork is also offered, including versions intended for the partially sighted.

Leaflets intended for the patient must be written in plain English and there is now a requirement in Europe for these to be user tested to ensure readability. Wainwright Associates provide a full readability testing service and can prepare test reports suitable for submission.

SPC, PIL and Labelling Texts

Wainwright Associates provide a writing service for Summaries of Product Characteristics, Patient Information Leaflets and labelling texts. These documents can be created from scratch or existing texts can be updated to reflect changes in the registered details or to improve readability.

Alternatively, we can assess clients’ own product literature, advising on the medical and scientific accuracy of the statements as well as checking for compliance with the registered details, the legal requirements, applicable guidelines and EU standard terms.

We will also check for consistency of the wording of the leaflet and the label with that of the SPC.

Texts of all the product literature are provided ready for inclusion in a Marketing Authorisation Application as well as with changes tracked, for ease of review by the client.

We can also advise on the requirements for labels and leaflets under the Clinical Trials legislation as well as create suitable product literature.

As part of SPC harmonisation, copies of SPCs approved in each EU member state can be sourced and reviewed for consistency, allowing a single, consolidated SPC to be proposed.

We work with a team of high quality medical translators to provide product literature in all the languages of the European Union. Back-translations can also be provided to check for authenticity. Linguistic review of texts in any language can also be provided.

Artwork Creation

Colour mock-ups of the leaflet and labels, meeting all the applicable guidelines and suitable for submission to regulatory authorities, can be provided in all EU languages. This includes the creation of a ‘worst case’ example, usually a trilingual leaflet or label.

Small packs can sometimes be a challenge and we can advise on the best way to meet the legal requirements for content and readability.

Artwork creation includes the label ‘blue box’ required under the EU Centralised Procedure. The blue box contains the information that is specific to individual member states, such as the legal status, pricing and reimbursement. Some countries also require barcodes or symbols and we can advise on the details required in each case.

Artwork is provided as PDF files suitable for electronic submission.

A recent development throughout the EU is the legal requirement to provide the product name in Braille on the pack and to have available a version of the leaflet suitable for the partially sighted, such as large print or an audio tape. We can advise on both these topics as well as provide the Braille translation.

Readability Testing

New legislation in the EU requires that all Patient Information Leaflets for new products must now undergo user testing for readability. By 2008 all products that are already authorised must also be tested. A formal test report is required to be submitted in the Marketing Authorisation Application.

The testing involves the design of a study protocol and a questionnaire focusing on the most important aspects of the leaflet.

Wainwright Associates have a panel of volunteers on whom the testing is carried out. These are members of the public whose demographic details are documented, so that a group can be selected with the appropriate profile for the intended use of the product.

Volunteers are interviewed by experienced testers and the responses to each question are recorded, noting whether, how easily and how accurately the volunteer located the required information. Testing is undertaken in the English language.

The test results are statistically analysed and reported and used to propose improvements to the readability of the leaflet. Comprehensive reports ready for submission to the authorities are provided.

The objective is to achieve a leaflet that passes the test in two rounds of testing, though further rounds may be required in exceptional cases.

For multiple products, we can advise on a matrix of testing that avoids the need to test every leaflet.