Electronic Product Information(ePI)

A collaboration of EMA-HMA-EC started a public consultation on 31 January 2019. The aim is to collect comments about ‘Draft Key Principles for the development of electronic Product Information (ePI)’. Download my Response [PDF-format, about 1MB]. A summary is published on LinkedIn.

Pictograms in package inserts?

The Dutch Regulatory Authority CBG/MEB asked on April 17 2018 for feedback about a proposal to use eight pictograms to warn patients. This brief response questions this approach and suggests an alternative. (In Dutch).

A minor headache? The design of information about ibuprofen (2014)

At a recent conference, a delegate asked me: “What’s wrong with the design of the information about medicines? It is all within the current legislation, it has been approved, and it can be produced for an acceptable price.” This essay simply looks at one English Ibuprofen pack and comments on the contents and design of the information.

[download pdf of ‘A minor headache?’]. The size is 4 MB to make sure that the photographs can be enlarged to see the details. This study was published in Information Design Journal 22(3). pp 281-297 and as chapter 18 (pp 336 - 354) in Emmanuel Tsekleves, Rachel Cooper (Eds.): Design for Healthcare (2017).

Falsification and pharmacovigilance (2014)

The effects of visual information in recent EU-legislation is overestimated. The actual performance of ‘logos’, ‘symbols’, ‘information campaigns’, and ‘packaging design’ is substantially lower than expected. [download pdf].


Comments about the Draft Readability Guideline in 2006. [download pdf] Many of the comments are still applicable to the 2009 Guideline.


What’s wrong with the template?’ (2008) describes and analyses of 271 problems with version 7.1 of the QRD-Template. Although version 8.1 is a substantial improvement, it still has many unresolved issues that hamper the development of information about medicines that ‘really enables the users to act appropriately’. [download pdf]

Developing information for patients

The files ‘Enabling users or readability’ (2005) [download pdf] and ‘Achieving harmonized patient information’ (2005) [download pdf] describe the problematic relations between the QRD-template, the EU-directives and the Readability guideline.