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Blog posts

What future for labelling regulations? 

To put it briefly: none of us knows! As the UK prepares to leave the EU, members of the Westmister Parliamen…Read more

European Commission reports on package leaflets, SmPCs

The European Commission has issued its report on the shortcomings of the Package Leaflet and Summary of Prod…Read more

Involving Users in Developing Health Information (PIF)

Involving Users in Developing Health Information was an event organised in London in May 2017 by Patien…Read more

Information Design Handbook

We are proud to be contributors to this authoritative reference book. Many in the Consumation team cont…Read more

Commission omission - an update

This is an update to our previous post.  The Commission’s Pharmaceutical Committee discussed t…Read more

Talking in Turkey

Consumation has completed a collaborative project with two workshops at Medipol University in Istanbul.…Read more

Is it us or is it them? Health literacy

Two things we at Consumation all share: a devotion to the users of medicines; and making information for the…Read more

Scanning the regulatory horizon 2013

After two meetings in 2012, and a pan-European survey in spring of 2013, we have signposts for the way Europ…Read more

Avoiding deviations

Also of interest to QRD are the deviations between leaflets on the market and those user tested. In a retros…Read more

Commission omission

Medicines information in the EU may look different in the near future, but only after we see the European Co…Read more

FDA plans new patient medication information (PMI)

Announced to a mainly industry audience of the Drug Information Association in Washington, autumn 2012, the …Read more

E-leaflets are our future

At meetings in 2012 and 2013 it became clear that the possibilities of electronic labelling (e-labelling) ar…Read more

The Pharma Packaging and Labelling Conference

In Rome in 2012, some consensus was built in a couple of days. The Pharma Packaging and Labelling Conference…Read more

Designing information before designers: print for everyday life in the 19th century

This January 2010 event took place at the St Bride Foundation, off Fleet Street in London – an area st…Read more

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Design research

Australian handbook – Writing about medicines for people

This is the book that started it all – the application of usability testing to medicines leaflets was …Read more

The MHRA handbook, Always Read the Leaflet

A more detailed document on the UK regulator’s recipe for better leaflets and user testing. A long doc…Read more

Plain language is not just for leaflets

It’s not just leaflets that need to be understood. The lay-language summaries of risk management plans…Read more

Research on the role and effectiveness of written information available to patients about individual medicines

A systematic review of quantitative and qualitative research on the role and effectiveness of written inform…Read more

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Guidance documents

EMA Pre-authorisation requirements

This is a useful start page for European pre-authorisation requirements. It includes a useful…Read more

The European Commission’s readability guideline

This is the core text for anybody drafting leaflets or needing to run usability testing in Europe. It is oft…Read more

EMA guidance: template version 10, and risk management in lay language

The pan-European regulator publishes a number of guidelines on its requirements for written style, for timet…Read more

Useful start page for UK MHRA document requirements

Patient information is the subject of more regulatory guidance than any other area of the MHRA’s opera…Read more

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