EMA Label & Artwork Regulations

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.


General Design considerations

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.

  • Name of the medicine: The full name of the medicinal product, with its strength and its pharmaceutical form, and if appropriate, whether it is intended for babies, children, or adults
  • Strength and total content.
  • Route of administration

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.

  • Acceptable to apply the batch number and expiry date to the end of the blister strip.


The name of the product followed by its strength should be put in Braille on the outer packaging (carton).

Corporate Trade Dress

  • Ensure that trade dress does not compromise key information of the medicinal product.
  • Company logos and pictograms may be presented, where space permits, on the outer packaging and on immediate packaging, provided they do not interfere with legibility of the mandatory information.
  • Choice of colour in product design must not introduce the risk of confusion.
  • Assess trade dress to determine the risk for medication error.
  • Pictograms and other graphics to aid comprehension are permitted, but exclude any element of a promotional nature.
  • The logo, format, layout, style, colour scheme, and if possible, the pack dimensions, should be identical for all the versions of packs of that medicinal product throughout the EU.
  • Trade dress can serve as an identifying mark and to create visual associations between multiple products from the same
  • It is important to assess trade dress to determine whether it may give rise to a risk of medication error and ensure that it does not compromise other distinguishing features of the medicinal.
  • Two or more products from the same manufacturer in the same therapeutic area which have a similar company trade dress present the possibility of mix-ups between the medicinal products.
  • Methods can be used to emphasize other key data elements on the outer packaging and on the medicinal product itself, to prevent mix-ups.
  • Highlight the different strengths by use of increased font size and a warning colour such as red.
  • Use of a ‘hatching’ effect to differentiate one similar product from another.
  • Introduction of a warning label to draw attention to critical information.
  • Consider the appearance and name of their medicinal product in comparison to medicinal products from other manufacturers used in similar indications, and the potential for confusion between medicinal products.

Strength Statement

  • Packaging may need to contain information on both the quantity per unit volume and on the total quantity per total volume.
  • Different strengths of the same medicinal product should be expressed in the same manner: for example, 250 mg, 500 mg, 750 mg, 1000 mg and NOT 1
  • Trailing zeros should not appear (2.5 mg and NOT 2.50 mg).
  • The use of decimal points (or comma) should be avoided where these can be removed (i.e. 250 mg is acceptable whereas 0.25 g is not).
  • It is important that micrograms are spelt out in full and not abbreviated.
  • Where this poses a practical problem, which cannot be solved by using a smaller type size then abbreviated forms may be used, if there are no safety concerns.
  • Strength statement should be in same field of view and immediately following the name of the medicine.

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.


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.


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.


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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