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1. ​   Objective
   The Drug Sector in Saudi Food & Drug Authority (SFDA) has developed this document to provide guideline for companies on the factors that need to be considered when choosing herbal or health products name and provide packaging design recommendations.
   
2.   Background
   
   The name of the herbal and health products" may be either a proposed name not liable to confusion with the common name; also it might be a common or scientific name accompanied by a trade mark or the name of the marketing authorization holder". This guideline is directed to applicant who are submitting a proposed name for herbal and health products, or submitting applications for name variation. In addition, it will help the applicant during the process of herbal and health products naming and give some recommendation on packaging design.
   The packaging graphic design in this guideline are ideal designs and intended for solid oral dosage forms, which are the most common type of primary packaging, while the secondary packaging used on the container label. The design considerations and principles outlined also can be applied to other products dosage forms.
   

​This guideline is applicable to SFDA registered or under-registration herbal and health products, which intended for human use in Saudi Arabia.

This document should be read in conjunction with the following drug sector documents:

- Data Requirements for Herbal & Health Products Submission

- Guideline for Presenting PIL and Labeling Information of Herbal and Health Products

- The GCC Guidelines for Variation Requirement.​

​​​1.    General criteria​

• The outer package, product label and PIL shall not include any images or figures that are:
• Violating Islamic laws, traditions and customs of society.
• Disgracing general modesty.
• Showing an advertising or promotional nature i.e., images or figures not related to the approved properties of the herbal or health product
• Referring to a herb, plant or active ingredient that does not actually exist in the herbal or health product.
• Referring to the protection from a specific medical condition.
• Affecting the clarity of information printed on the outer package.
• The outer package, product label and PIL shall not include any logos or phrases that are:
• Violating Islamic laws, traditions, or customs of society.
•  Disgracing general modesty. – Referring to the protection from a specific medical condition.
• Containing information misleading the customer by overstatement the efficacy of herbal product, for example: effective, guaranteed, magical, etc.
• Incomprehensible or cannot be verified by public, for example: clinically proven.
• Referring to a herb, plant or active ingredient that does not actually exist in the herbal or health product.
• Referring to the therapeutic effect of the herbal or health product.
• Referring to registration and marketing in other countries, for example: " FDA approval & No.1 in market X "
• Primary or secondary package shall not lead to confusion with another herbal or health or pharmaceutical product (in color or design).​

2.   Design Recommendations for Primary Packaging (Blister Packs)

2.1      Product name and strength

The name and strength of the product should appear over each blister pocket. Batch number and expiry date should be applied on each blister pocket as well. If it is not possible, the batch number and expiry date should be added at the end of each blister strip, preferably at both ends.

2.2      Blister strips foil

Use non-reflective, matte material. Reflective foil can cause glare by light reflecting on the foil which reduces the legibility of any information.

2.3      Type and background color

The color type should contrast strongly with the color of background. Legibility can be reduced by the combined effect of the foil material, a small font size and a background color that does not sufficiently contrast with the font color.

2.4    Type size and font color

Use bold or semi-bold type and avoid lightweight type.  Maximize the font size to a size that is appropriate for the size of the container. Small type size and a lightweight font on a foil background impairs legibility.

2.5  Match the styles of primary and secondary packaging

A product's primary and secondary packaging should have an identical or linked visual style.

3.  Design Recommendations for Secondary Packaging

Secondary packaging represent the outer package of a product. It serves to hold the primary packaging and is not in contact with the product. The combined impact of all design elements, such as color and typography, should be evaluated.

3.1      Typing important information in the same field of vision on at least three non-opposing faces (one side for Arabic & one side for English)

A standard packaging container has six faces on which information can be displayed. Critical information should be in the same field of vision on at least 3 of the non-opposing faces of the secondary packaging. This means putting the information on the top or bottom face, one of the sides, and one on the ends. If it is feasible, display a product description (the brand name, generic name and dosage strength of the product) on more than three non-opposing faces.

  3.2      Orient text in the same direction

The text on every face, excluding the ends, should be oriented in the same direction in a way to simplify the reading of the product's information when it is placed at any side on the shelf.

3.3      Use blank space to emphasize important information

Leave sufficient space around important information, so that it can be easily seen. If the secondary packaging is cluttered with text and images, it can be difficult to recognize important information and identify the correct packaging.

         Important information like

1. Brand and active ingredients of the product.
2. Strength and dosage form.
3. Total volume or concentration of bottle, plus the “per mL" amount (e.g., 10 mg/2 mL and 5 mg/mL).
4. Warning statements in some cases.
   
   

3.4      Ensure the active ingredients names are clear

The active ingredients names should be at least 50% the size of the brand name.

3.5      Do not add trailing zeros to numbers

Do not add trailing zeros to numbers; always use whole numbers.

3.6      Use the same unit for all different strengths from the same Herbal and Health Products

In addition, different strengths of the same product should be expressed in the same way, such as 250 mg, 500 mg, 750 mg. (e.g., 500 mg, not 0.5 g)

3.7      Use of leading zero

For an amount less than one, always use a leading zero to avoid any confusion in the concentration (for example use 0.25 not .25).

3.8      Information size

Use the largest possible size font for that package so that the information is readable and clear.

3.9      Use upper and lower case lettering

Entire sentences written in upper case letters or italic type are hard to read. Use the lower case except for the first letter of the generic names, brand names, sentences or paragraphs. Italic types should not be used where there is an alternative method of emphasis such as bold type. Mixed case lettering should always be used for sentences.

3.10    Use sans serif typefaces

Use a sans serif typeface, such as Arial, Helvetica or Universe. The choice of typeface influences legibility. Ornate typefaces are difficult to read. They are not suitable for medication packaging, where clarity, accuracy and legibility must be paramount.

3.11    Use bold or semi-bold type

Lightweight type reduces legibility. Patients, especially those who are partially sighted, find bolder type easier to read. Use bold or semi-bold type and avoid lightweight type for all important information.

3.12     Condensed typefaces

Do not use condensed typefaces when possible. Condensed typefaces reduce legibility. Condensed typefaces may be necessary on blister packs on each pocket to fit all the required information, but should not be used when there is adequate space for normal typeface.

3.13     Do not compress lines of text close together or adjust the space between  letters ​

Reducing the space between lines, known as the leading, and between letters, known as the kerning, affects legibility. Do not compress lines of text close together.  Leave enough space between lines and letters.

3.14       Align text to the left for English & to the right for Arabic

An irregular amount of space between words affects legibility. Align text to the left hand margin and do not center justify text. Align all English text including the important information to left side (left justified) and for the Arabic version, it should be aligned to the right side (right justified).

3.15       Images and logos

Images or logos should not be near the text, as it could interfere with reading it, or it may look like it is part of the text. Text should remain unbroken. Fitting text around or over images or logos breaks the flow of information.

3.16​    Create a strong contrast between type and background color

• There should be a strong color contrast between the type and background colors. Dark colored type (e.g. black, dark blue) should be on a light colored background (e.g. white, pale pink, pale yellow). The reverse is true as well. Insufficient contrast between the background and the type reduces legibility.

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