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Leaflet digitalization in the European Union?

Photo by Danielle Rice - map of europe
Photo by Danielle Rice

If you follow us, you would remember an earlier article about changes in the pharmaceutical industry in the last years, around tools and technology for document management.

Was it an exponential change in the industry ?

Some examples of these changes are:

  • A paper archive/database
  • Tracing in an spreadsheet
  • Control of changes on paper
  • Email or Fax as project manager
  • Visual Artwork review
Photo by EMA

These types of processes are now a thing of the past, and are being replaced by Artwork Management systems, and proofing tools that take change management to a totally new level.

The change has been enormous and more changes could be needed due to agreements between the European Medicines Agency (EMA) , management at Medicine agencies (HMA) and the European commission projects from 2018, aiming at a digital transformation in sanitary support in the European Union (see the draft here: EMA)

This transformation has implications that are beyond my knowledge, but some of the phases that it entails were:

  • March 2017 – report from the European Commission with an action plan for the EMA to identify areas susceptible of improvement to satisfy the needs of patients and professionals.
  • 2018 – collaboration between EMA-HMA-EC identifying the needs for a future digitalization.
  • March 2017 – report from the European Commission with an action plan for the EMA to identify areas susceptible of improvement to satisfy the needs of patients and professionals.
  • 28 november 2018 – EMA runs a workshop with patients/consumers, health professionals, interested parties in the industry, academics, NGOs and regulators. This returned the key principles of this process.
  • February to July 2019 – public consultation with over 500 comments.

After reviewing these comments in relation to the key principles defined, a pilot program emerged in January 2022, aimed at evaluating the impact of the removal of the paper leaflets in a small portion of medicines for human use, within hospitals.

These medicines should include in their primary packaging a non serialised Data Matrix code that, once captured, would allow direct access to the digital version of the leaflet from the information allocated in CIMA.

Photo by Rodion Kutsaev

The pilot duration will be at least 2 years, and it will be implemented progressively.

Would there really be a digitalization in health assistance in the European Union? I believe that after all the effort, this will become a reality. The only question is to what extent is the EU capable of coordinating for the big change of digital times.

And you, are you ready?

Rafael Cruz Núñez
Artwork Manager
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Standardizing products in the pharmaceutical industry

patrick tomasso unsplash

Homogeneize/Standardize is the process to harmonize or confer homogeneity or unity to the elements of a set or an area. When it comes to our packaging, it has many other implications:

  • Identification & communication of attributes and visibility.
  • Item Distribution Strategy.
  • Increase in perceived value of the product.
  • Brand recognition.
  • Loyalty.

With the term defined and considering the high strategic importance of standardizing our packaging, we are going to focus on how to deal with the production of (standardize) materials.

What is the best way to guarantee that our team of designers produce homogeneous materials?

Without a doubt, it is the use of templates. These templates, which are expected to be a shared resource, must be unique and protected to avoid changes and therefore generate unwanted deviations.

It is important to develop as many templates as types of products are in our portfolio. These types or groups of products have similar content, form and distribution:

  • Blister box
  • Vertical box
  • Label
  • Leaflet
  • Blister

Using a Folding Box as an example, our template must contain: logos and corporate identity signs, road safety or photosensitivity icon, recycling symbol(s), dosage chart and a long etcetera depending on the complexity of our design.

In order to complete our template, we are currently still missing a fundamental element. It is of vital importance to have a mockup in our template so that designers can use the elements that compose it when building new products.

Back to our example of a Folding Box. In our mock-up there will be a set of elements in the front face such as the name of the product/component in the correct corporate font, size and formatting that would help the designer create the final material. Very important is to make sure that these elements are not to be specific and refer to a real product/component. These should contain a generic text, such to avoid human errors by not replacing the correct text from the Medicines Agency.

For example: Molecule Brand 00 xx xxxxxxx xxxxxx EFG – all these in the correct font and sizes/styling.

Austrian national library – unsplash

Besides reducing risk of mistakes, another benefit of using templates is to exponentially speed up the design process. The template is expected to already solve many questions when starting producing a material: What font should I use? Where are the logos and icons? What were these products like that I haven’t worked on lately?…

To finish with our recommendations to standardize your designs with the use of templates, it is important to highlight that a template is subject to real and common cases. What does this mean? The template should be simplified as much as possible so that its use is agile and efficient, therefore, they should not include exceptions or extreme cases when creating the template.

Our template must encompass the common elements of at least 90% of our materials, as well as our guide or procedure for a material that you can see in a previous article: Facing a Rebranding without stress.

Rafael Cruz Núñez
Artwork Manager