What should be considered when designing medication boxes, package inserts, and labels according to EMA regulations? Through our comprehensive guide, we try to explain what factors play a role in getting your pharmaceutical packaging approved.
The European Medicines Agency ensures that Life Science products meet safety, effectiveness and quality requirements before giving a green light for distribution in 28 EU member states, Iceland, Lichtenstein, and Norway.
Minimum font use for labeling should be 7 points.
Critical items necessary to be listed for safe use of medicine and in the same field of view.
Make use of the space to ensure essential information is clearly mentioned in sufficient type size on prime spaces on the outer and immediate packaging.
Logos and pictograms may be used, where space permits, on the packaging, provided they do not interfere with the legibility of the mandatory information.
Consideration should be given to the line-spacing and use of white space to enhance the legibility.
Innovative techniques in packaging design to aid in the identification and selection of the medicinal product is encouraged.
Where space permits, there should be a clear demarcation between languages where multi-lingual packaging is proposed.
All outer packaging must include space for the prescribed dose to be indicated and/or “blue box” information as required by Member States.
It is recommended to group different text elements for each language, where appropriate.
For blister packs often, it will not be possible to apply all the information over each blister pocket, information should frequently appear across the pack.
The name of the product followed by its strength should be put in Braille on the outer packaging (carton).
The particulars appearing on the label of all medicinal products should be printed in characters of at least 7 points
Space between lines of at least 3 mm
Make best use of the space available to ensure that the essential information is clearly mentioned on prime spaces on the outer and immediate packaging, presented in a sufficiently large type
Company logos and pictograms may be presented, provided they do not interfere with the legibility of the mandatory information.
Consideration should be given to the line-spacing and use of white space to enhance the legibility of the information provided.
Where a multi-lingual outer and/or immediate packaging is proposed there should be a clear demarcation between different languages where space
All outer packaging must include space for the prescribed dose to be indicated and/or “blue box” information as required by Member
A different type size or colour is one way of making headings or other essential information clearly recognisable.
Dark text should be printed on a light background, but there may be occasions when reverse type could be considered to highlight for warnings.
Colors should be chosen to ensure a good contrast between the text and the background to assure maximum legibility and accessibility of the information.
Highly glossy, metallic or reflective packaging should be avoided, as this affects the legibility of the information.
Assorted colors in the name of the product are discouraged since they may negatively impact on the correct identification of the product name.
The use of different colours to distinguish different strengths is strongly recommended.
The number of colors used on packs will need careful consideration as too many colours could confuse.
Where color is used on the outer pack, it is recommended that it is carried onto primary packaging to aid identification of the medicine.
For blister pack presentations legibility of the text on the foil is already impaired, so color for the text should be chosen carefully.
Where possible, nonreflective material or coloured foils should be considered to enhance the read- ability.
Text
A minimum type size of 9 points, not narrowed, with a space between lines of at least 3 mm.
Use different text sizes to enable key information to stand out and to facilitate navigation.
Use larger type size where a medicinal product is especially intended for visual impairment.
The widespread use of capitals should not be used; however, capitals may be useful for emphasis.
Do not use italics and underlining. Italics may be considered when using Latin terms.
Justified text should not be used.
The margin between the columns should be large enough to adequately separate the text.
Formatting
Background images should not be placed behind the text since they may interfere with the clarity of the information.
If space is limited a vertical line to separate the text may be used.
The space between lines should be at least 1.5 times the space between words on a line.
Related information should be kept together from one column to the next.
A landscape layout is preferred because it can be helpful to patients.
There should be a clear demarcation between the different languages used.
Bold type face or a different color for the heading may help make this information stand out.
The spacing above and below the headings should be consistently applied throughout.
Same level headings should appear consistently to aid the reader.
More than two levels of headings may make it difficult for readers to navigate the leaflet.
Where complex information is communicated multiple levels of headings may be needed.
Using lines to separate the different sections within the text can also be helpful.
Language
Use simple words of few syllables.
Long sentences should not be used.
Use bullet points instead of long paragraphs
When writing, an active style should be used, instead of passive.
When telling patients what action to take, reasons should be provided.
Use “Your medicine, this medicine, etc.” rather than repeating the name of the product.
Symbols and pictograms should only be used to aid navigation, clarify or highlight certain aspects of the text and should not replace the actual text.
Use simple words of few syllables.
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