This document provides guidance on leaflet packaging design using Adobe Illustrator. It discusses differences between raster and vector images, common tools in Illustrator, and guidelines for design elements like type style, size, color, and layout. The goal is to enhance readability and safety by achieving proper spacing, contrast and proximity of information. Examples are given for converting raster to vector, creating a new leaflet template, and modifying an existing one to comply with guidelines.
2. Maher Al-Absi
Stability Study Specialist
R&D Center
Global & Modern Pharma.
https://www.linkedin.com/in/maher-al-absi-5579009b https://www.facebook.com/Maheralabsy
28. Leaflet Design
Regulatory Guidelines
(PILs) PATIENT INFORMATIONL LAFLETS
The Readability Guideline published by the European Commission
gives detailed guidance on the minimum font size which is
considered to be acceptable.
TYPE SIZE AND FONT
Choose a font which is easy to read
Stylised fonts which are difficult to read should not be used
• A type size of 9 points (as large as possible to aid readers)
• As Times New Roman (not narrowed)
• Space between lines least 3 mm. as minimum
For marketing authorisation applications until 1 February 2011
• A type size of 8 points
• Font ‘Times New Roman
• A space between lines of at least 3 mm
29. Leaflet Design
Regulatory Guidelines
(PILs) PATIENT INFORMATIONL LAFLETS
Column format
The margin between the columns should be large enough to
adequately separate the text. pful in creating a feeling of
openness about the information being presented.
The use of columns which are familiar to most readers through
newsprint help readers to easily assimilate information.
30. Leaflet Design
Regulatory Guidelines
Good Label and Package Practices
Guide for Prescription Drugs
This guide was prepared with the
collaboration of ISMP Canada
Good Label and Package Practices
Guide for Non-Prescription Drugs &
natural Health Products
June 30, 2016
May 31, 2017• 1 Overview of the Guide
• 2 Designing Labels and Packages for Safety
• 3 Drug Facts Table for Non-prescription Drugs
• 3.1 Background
• 3.2 Content
• 3.3 Design and format
• 3.3.1 Formatting
recommendations
• 3.4 Application of graduated flexibilities
• 3.5 Category IV products, mouthwash
and toothpaste
• 3.6 Innovative labels
• 3.7 Product facts table for natural health
products
• 1. Overview of the Guide
• 2. Considering Users and Their Environments
• 3. Designing Labels and Packages for Safety
71 pages
89 pages
31. 3.3 Design and layout
3.3.1 Type style and size
3.3.2 TALLman lettering (Only in Prescribed drugs )
3.3.3 Proximity and compatibility of information on the principal display
3.3.4 White space
3.3.5 Colour and contrast
3.3.6 Use of abbreviations, symbols, and dose designations
3.3.7 Bilingual labelling
3.3.8 Logo, branding, and trade dress
3.3.9 Permanence
Leaflet Design
Regulatory Guidelines
32. Type Style (Typeface)
• When choosing a type style, consider that different
styles of the same point size do not appear the same
in size
Calibri 9 point
Arial 9 point
Arial Black 9 point
Univers 9 point
Verdana 9 point
• Use of a sans serif type style: not
compressed , expanded, or decorative.
• Choose a type style with adequate spacing
between letters.
• Avoid using all capital letters.
• Avoid the use of italic type except to
emphasize a particular portion of text.
Leaflet Design
Regulatory Guidelines
• Type Size
• Use a type size that can be read
easily by a variety of users (e.g.,
elderly people, those with
visual
impairment)
• The largest type size possible is
recommended. However, a
point size less than 6 should
not be used
for key information.
(1) Type style and size
The following recommendations do not apply to trademarks, copyrighted text,
and logos.
May 31, 2017
Main Aim:
To Enhance Readability
Design and layout
33. • General formatting
To Enhance Readability
• Use flush left, ragged
right alignment to
provides visual points of
reference that guide the
reader’s eye smoothly,
Since each one shorter or
longer than next .
• Use bullet lists, if
possible.
Leaflet Design
Regulatory Guidelines
(1) Type style and size
The following recommendations do not apply to trademarks, copyrighted text,
and logos.
May 31, 2017
Main Aim:
To Enhance Readability
Design and layout
• Use contrasting
characterstics eg.
• (type,size,weight,bolding,
colour,and spacing).
• CAUTION: Keep out of children. (Bold)
• Do not take more than recommended
dose.
34. • Proximity and compatibility can be affected by other label and type attributes, such as
colour, type style, andtype size and weight.
• Use of the same colour(s), type style, point size, and markings or graphics can
inadvertently link pieces of information (e.g., numeric values) even when there is
physical distance between them on the label.
• Avoid placing unrelated information (Including graphics).
• Avoid superimposing textand images (or logos).
• List the standard of manufacture, as applicable (e.g., Pharmacopei[USP],[BP]).
Leaflet Design
Regulatory Guidelines
(2) Proximity and compatibility of information on the principal display
May 31, 2017
Main Aim:
To Enhance Readability
Design and layout
35. • White space surrounding text can create a feeling of openness, also it helps the reader
to focus on what they reading.
• Help health professional the reader to find the information that they need to facilitate
safe product use.
Leaflet Design
Regulatory Guidelines
(3) White space
May 31, 2017
Main Aim:
To Enhance Readability
Design and layout
Recommendation :
• Incorporate white space as part of the design and layout of info. :
• Frame by use eg(Bulleted list) .
• Separate paragraphs (to distinguish one idea from another )
• Maximize the use of white space to avoid crowding info.
36. • Color
• The effect of colour in label design can be affected by colour-blindness. Colour-blind usersmay have difficulty in
reading text in particular colour combinations or on
particular colour backgrounds
• Contrast
it has been recommended that text of a dark colour be used on pale backgrounds to ensure
sufficient contrast for optimum visibility.
• Colour Differentiation and Colour-Coding
(e.g., red may convey danger, orange may convey a warning, yellow may convey the need for caution).
• Use colour for the following purposes:
o to draw attention to important label information,10 such as the name of a health product and its strength.
• When selecting colours for labelling and packaging, consider the potential implications of colourblindness (e.g., avoid
using both red and green together
Leaflet Design
Regulatory Guidelines
(4) Colour and contrast
May 31, 2017
Main Aim:
To Enhance Readability
Design and layout
37. • The use of certain abbreviations (e.g., OD), symbols (e.g., μ), and dose designations (e.g., 1.0
mg) to convey
health product-related information has been identified as an underlying cause of serious, even
fatal errors.
Leaflet Design
Regulatory Guidelines
(4) Use of abbreviations, symbols, and dose designations
May 31, 2017
Main Aim:
To Enhance Readability
Design and layout
Recommendation :
• Minimize use of abbreviations, symbols, and dose designations in health product
packaging and
labelling
38. • Bilingual labelling may pose challenges for the readability of inner and outer labels because of
the possibility of
crowding of information.
Leaflet Design
Regulatory Guidelines
(5) Bilingual labelling
May 31, 2017
Main Aim:
To Enhance Readability
Design and layout
39. • Bilingual labelling may pose challenges for the readability of inner and outer labels because of
the possibility of
crowding of information.
Leaflet Design
Regulatory Guidelines
(6) Logo, branding, and trade dress
May 31, 2017
Main Aim:
To Enhance Readability
Design and layout
Recommendation :
• Logos and trade dress on product labels should not distract the user or impede the
effective communication of key information to the user.
• Strive for balance between the use of corporate trade dress and the presentation of key
information on
labels.
40. • Bilingual labelling may pose challenges for the readability of inner and outer labels because of
the possibility of
crowding of information.
Leaflet Design
Regulatory Guidelines
(6) Logo, branding, and trade dress
May 31, 2017
Main Aim:
To Enhance Readability
Design and layout
Recommendation :
• Logos and trade dress on product labels should not distract the user or impede the
effective communication of key information to the user.
• Strive for balance between the use of corporate trade dress and the presentation of key
information on
labels.
41. • The safe labelling of health products ensures that all information is readable for the duration of
the shelf-life of the product.
Leaflet Design
Regulatory Guidelines
(7) Permanence
May 31, 2017
Main Aim:
To Enhance Readability
Design and layout
Recommendation :
• Ensure that print on products will remain legible for the entire life of the product, taking
into consideration transportation and storage conditions, as well as environments of
use.
• Consider special technologies, such as smudge-resistant paper stockand inks
containing adhesives, which will bond to a variety of surfaces, including plastics.
• Use inks that are resistant to isopropyl or ethyl alcohol and that will be durable
enough to withstand normal handling, particularly for injectable products (e.g.,
ampoules, vials, prefilled syringes).
44. Intro.
Color
C Cyan
M Magnta
Y Yellow
K Black
C M Y K
C M Y K
Diff. bet CMYK (Mode) VS Panton(System)
Painter has four heads
Problems
No Similarity
Ink Ink Ink Ink
45. Intro.
Color
C Cyan
M Magnta
Y Yellow
K Black
Panton
377C 301C
Diff. bet CMYK (Mode) VS Panton(System)
Similarity
Ink Ink
48. Samples
Original Company
10.8 pt
Font
Size
Space
Bet. lines
Ar EN
7 pt
BayerSans-Bold
BayerSans-Bold
DejaVuSansCondensed
8 pt
9 pt
Arial Regular
Arial Bold 10 pt 12 pt
Arial Regular
Arial Bold 8 pt 9 pt
Arial Regular
Arial Bold
Times New Roman Regular
Times New Roman Bold
50. Application
on Adobe Illustrator
Known Leaflet Dimension and
Color specification.
Use Times New Roman Regular
Times New Roman Bold for
Impotant info.
Suitable font size and space
bet. lines
Draw the Grids line (recommended Multi-grids)
Leave enough space bt. colums
51. Application
on Adobe Illustrator
• How to Converting Raster Vector.
• Creating new leaflet for A to Z.
• Old Designed PATIENT INFORMATION LAFLETS
Notice the modifies it (Results).
• Export Ai to PDF and Outline.