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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. DSSPL can advise on the regulatory
requirements for both content and format under 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.
DSSPL can offer full readability testing service and
can prepare test reports suitable for submission.
SPC, PIL and Labelling Texts
DSSPL 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 standard terms.
We will also get it checked for consistency
of the wording of the leaflet and the label with that
of the SPC.
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
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.
DSSPL is associated with the consultants in EU who
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 with no trouble 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.
