Guideline influence

Many of our study results and recommendations have been implemented in European Union directives and guidelines. This applies to:

MAH representative list in package inserts no longer required

PAINT-Consult has for many years now recommended the deletion of the MAH representative list for many years now, as this information is less important and contributes up to 25 % of the package insert volume. Examples of our input include the following publications:

  • readability test study of the QRD template and a shorter model template (PDF)
  • PAINT1 study (PDF)
  • study of the importance of package insert information (PDF)

The EMA has stated that this list is no longer essential according to EU legislation. The QRD template has already been amended. Please do not hesitate to contact us if you require any further information.

The written readability test method - developed by PAINT-Consult

In its position paper from February 2011, the CMDh once again recommended PAINT-Consult's written readability test method as an alternative to the Australian interview method in its position paper from February 2011 (PDF).

Further examples of official recognition by European medicines agencies of the written readability test, as used and developed by PAINT-Consult, are: the British medicine agency MHRA (PDF) and the German medicine agency BfArM (PDF).

Pharmacovigilance project

The European Commission (PDF) informed PAINT-Consult that it would like to take the ideas and results published in our article in the Drug Information Journal (2010), "The way forward in package insert user tests from a CRO's perspective" into consideration (PDF, see chapter discussion and the following page).

In September 2010, in accordance with PAINT-Consult’s recommendations, the European Parliament and the Council of the European Union rejected the summary box for the most essential information in package inserts and the emphasising of new information (PDF). Both of which formed part of the pharmacovigilance proposal (PDF, see page 25).

9pt as minimum font size in package inserts

In the readability guideline (PDF) the European Commission stipulated a minimum font size of 9pt as recommended by PAINT-Consult (PDF), instead of the previously recommended 12 to 20pt (PDF).

Side effect frequency explanations

The frequency explanations of side effects in package inserts, which were developed and tested in the PAINT1 study, received the recommendation of the EMA and various patients' organisations in September 2007 (PDF, see page 4).

The BfArM has recommended these frequency explanations, as developed by PAINT-Consult, since April 2007 (PDF).

Order of information

A new sequence of information within package inserts for the European Union was published in Directive 2004/27/EC, article 59 (PDF). This largely corresponds to our recommendations based on the study with 855 patients in 2001 (PDF).

The results of PAINT-Consult's 2005 study, with 219 healthcare professionals, prove that this new order has significantly optimised package inserts (PDF).

Last update: 21.02.2019

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