Guidance for Graphic Design of Medication Packaging

The guidance is complementary to the GCC Guidance for Presenting the SPC (Summary of Product Characteristics), PIL (Patient Information leaflet), and Labeling Information with more illustrations and details to minimize medication errors.  

The design considerations and principles outlined can be applied to all products dosage forms.​

This guidance is applicable to Saudi Food and Drug authority (SFDA) registered or under-registration medicinal products intended for human use in Kingdom of Saudi Arabia.​

​One of the main tasks of SFDA is to regulate and control drugs to set the necessary regulations for it.[1]  According to article (19) of Law of Pharmaceutical and Herbal Establishments and Preparations the packages of pharmaceutical products should determine by the authority.[2]

​[1] Article (2) Implementing Regulations of Saudi Food and Drug Authority Law Promulgated by Royal Decree No (M/6) of 25/01/1428 AH

[2] Royal Decree No (M/108) of 15/04/2020​

This document should be read along with regulations, procedures, guidelines, circulars and decisions issued by SFDA, for example the following:

• - Data Requirements for Human Drugs Submission

• - Guidelines for Variation Requirements

• - Guideline on Good Pharmacovigilance Practices (GVP)

• - Guidance for Medication Error Reporting​​

​​​1.1 ​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.​ Figure 1

Optional: If the medication is given every day, print the days of the week on the reverse side of the blister or capsule. Figure 2

In certain cases (such as: small blister) it may not be possible to design the packaging to accommodate all critical information on each blister cell. In such circumstances, important information can appear multiple times across the back of the blister or the important information should be displayed in such a manner that it is not destroyed or eliminated when dosage units are removed.​

1.2 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. Figure 3

1.3    Font and Background Color 

Font color should contrast strongly with background color. 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. Figure 4​

1.4    Font Size and Font Color 

Use bold or semi-bold font and avoid lightweight type.  Maximize the font size to a size that is appropriate for the size of the container. Small font size and a lightweight font on a foil background impairs legibility. Figure 5

1.5    Match the Styles of Primary and Secondary Packaging [Optional]

A product’s primary and secondary packaging may have an identical or linked visual style. Figure 6

​Secondary packaging describes the outer package of a pharmaceutical 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.

​Company's pharmaceutical products should not have the same theme for outer package and should differentiate between them, to avoid similarity between products and prevent medication error.

​​Have a clearly designated white space for the dispensing label if possible. Label dimensions vary but a minimum of 70 x 35 mm is suggested, as this is the most common size for dispensing. The white space should not interfere or cover the legibility of the critical information on either side.​ Figure 7
1.1 Brand Name, Generic Name and Strength Position

The brand name, generic name and strength of the product should be directly above or beside the space provided for the dispensing label. Pharmacy staff can then easily check that the product description on the dispensing label correctly matches that on the secondary packaging. ​​Figure 8​

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 side faces, and one of the end faces. 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. Figure 9

3. Orient Text in The Same Direction [Optional]

The text on every face, excluding the ends, should be oriented in the same direction in a way to easily read the information when the product is placed at any side on the shelf. Figure 10

4. Use Blank Space to Emphasize Critical Information 

Leave sufficient space around critical 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.

Critical information included on the principal ​display panel must be displayed in the following order and separately from each other:

1. Trade / brand / proprietary name

2. Generic Name

3. Strength /concentration 

4. Route(s) of administration

5. Dosage form

6. Total volume or net quantity.

7. Warning statements in some cases.

8. Indications for OTC only.

9. Storage conditions must be added in both Arabic and English languages. They can be presented on the side panels

Figure 11

5. Ensure the Generic Product Name Is Suitably Clear

The generic name should be at least 50% the size of the brand name. Patients may be (mistakenly given) two generic products (with the same active ingredient). Patients may take concomitantly two products with the same active substance, putting them at risk of exceeding the safe dose. Figure 12

6. Differentiate Between Strengths of the Same Pharmaceutical Product 

Make pharmaceutical product strengths stand out through typeface, font type color and shape. This is particularly important if all secondary packaging from a manufacturer looks similar. Figure 13

7. Do Not Add Trailing Zeros to Numbers

Do not add trailing zeros to numbers; always use whole numbers. If numbers have a trailing zero (a decimal point followed by a zero, for example 5.0 mg) it is easy to miss the decimal point and dispense a tenfold overdose. For example, a practitioner could administer 50 mg instead of 5 mg.  Figure 14

8. Use the Same Unit for All Different Strengths from the Same Pharmaceutical Product 

In addition, different strengths of the same pharmaceutical product should be expressed in the same way, such as 250 mg, 500 mg, 750 mg. (e.g., 500 mg, not 0.5 g)  Figure 15​

9. 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). Figure 16

10. Critical Information Size

Use the largest size font possible for that package size so that the information is readable and clear. Figure 17

11. Use Upper and Lower Case Lettering

Entire sentences written in upper case letters or italic font 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.  Figure 18

12. Abbreviations

The critical information on the outer package, such as the route(s) of administration and dosage form, must be written in full, without the use of abbreviations. This is to avoid confusion or misinterpretation and ensure that all essential information is clearly displayed. 

13. Tall Man Lettering

Changing the appearance of look-alike drug names to draw attention to their dissimilarities by using TALL Man Letters with bolded uppercase letters.

14. Use Sans Serif Font

Use a sans serif font, 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. Figure 19

15. Use Bold or Semi-Bold Font

Lightweight font reduces legibility. Patients, especially those who are partially sighted, find bolder font easier to read. Use bold or semi-bold font and avoid lightweight font for all critical information. Figure 20

16. Condensed Font

Do not use condensed typefaces when possible. Condensed typefaces reduce legibility and increase the chance of error. Condensed font can be used on blister packs on each pocket and on small vials to fit all the required information, but should not be used when there is adequate space for normal typeface. Figure 21

17. Do Not Compress Lines of Text Close Together or Adjust the Space Between 

Reducing the space between lines, known as the leading, and reducing the space between letters, known as the kerning, affects legibility. Do not compress lines of text close together.  Leave enough space between lines and letters. Figure 22

18. 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 critical information to left side (left justified) and for the Arabic version, it should be aligned to the right side (right justified). Figure 23

19. Languages 

Display information on packaging using Arabic and English language only. Avoid using any other foreign languages

20. Images and Logos

Images or logos should not be near the text, as they could interfere with reading it, or they may look like they are part of the text. Text should remain unbroken. Fitting text around or over images or logos breaks the flow of information. Figure 24

21. Create a Strong Contrast Between Font and Background Color

There should be a strong color contrast between the front and background colors. Dark colored font (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 font reduces legibility.

Figure 25​

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

1.  Use Color Differentiation to Highlight Information of the Same Pharmaceutical Product

Use color to distinguish between, for example, different strengths of the same pharmaceutical product and between similarly named pharmaceutical products. 
Figure 26

​Do not color code packaging. A color-coding system allows people to memorize a color and match it to a particular product. However, creating a shortcut for identifying a pharmaceutical product without having to read the label can lead to mistakes. It is important that practitioners do not rely on color as a means to identify a specific product, as many manufacturers may use the same color for different products, or different strengths of the same product.

1.1. Features of Front Panel

Create a front panel that features only the critical information. Subsequent (noncritical) information can be shown on the back panel.

Minimum information consists of:

• Trade name

• Generic drug name

• Concentration of the pharmaceutical product:

- Total quantity in the container (large font)

- Concentration per unit volume (smaller font).

• Administration route(s)

• Significant Warnings

• Type of containers based on:

- the number of doses i.e. (multiple-dose or single-dose containers) 

- the number of users i.e. single patient use.

Figure 27

1.2. Use of color

Use color to highlight key differences in information: the drug name, the quantity concentration or warning if appropriate. 

Apply the color scheme consistently throughout the primary and secondary packaging. Figure 28

2.1. Text Orientation

Print the pharmaceutical product name longitudinally, along the length of the ampoule. A good rule of thumb is: if the visible width of the label is less than the height of the label then the name should be printed longitudinally.

• The information listed below is the minimum and must be present on containers more than 10 ml   (the small container exceptions apply to containers of 10 ml or less): 

1. Pharmaceutical product name (brand name and nonproprietary name)

2. Expression of strength 

3. Route of administration

4. Warnings, where important

5. Expiry date

6. Batch number

7. Marketing authorization holder

Figure 34

2.2. Labeling Methods

- Use paper labeling where possible, and ensure that the label does not wrap completely around the ampoule to allow for inspection of contents.

If ceramic or clear plastic labeling must be used, highlight key information by inverting the text color. 

Keep information to a minimum and reduce overlapping with text from the reverse side as much as possible.

Labels should not come off in use and should be printed with ink that does not run when sprayed with alcohol to disinfect the ampoule surface in the pharmacy or during clinical procedures. Figure 35​

- We recommend the addition of a peel-off label on ampoules or vials, which can be transferred to a syringe in practice, will help practitioners avoid selection errors. All syringes containing pharmaceutical products should be labeled if they leave the operator’s hands. Figure 36

2.3. Plastic Ampoules

• Use a clear font size.

• Information should be printed on paper label, if possible or direct on the ampoule with good contrast color.   

• Use color to help to differentiate between products of the same company.

• Eliminate or reduce emphasis on the name of the container type such as ‘Plas-Amp’. 

• Expiry dates and batch numbers should be easy-to-read and printed on the main body of the container, not on rip-off tabs. 

• Where concentrations are shown, they should be expressed as total quantity in total volume (e.g., 20 mg per10 ml) as well as the per unit volume (e.g., 2 mg/ mL).

• Highlight the route of administration to avoid wrong route errors between products packed in plastic containers.

​​3.1. Critical Information Panel 

Create an area, which highlights the critical information. This area should not be wider than the width of the bottle in order to allow seeing the critical information without the need to turn the vial (i.e., along a single line of vision).

Use appropriate font size and formatting to enable the generic drug name to be read in one glance. The generic name should be at least 50% the size of the brand name. Figure 38

3.1.1. Neuromuscular Blocking and Paralyzing Agents 

All injectable neuromuscular blocking agents and paralyzing agents must be packaged in vials with a cautionary statement printed on the ferrules and cap overseals. Both the container cap ferrule and the cap overseal must stand out in black or white print (whichever provides the greatest color contrast with the ferrule or cap color) the words: “Warning: Paralyzing Agent” or “Paralyzing Agent” (depending on the size of the closure system). Alternatively, the overseal may be transparent and without words, allowing for visualization of the warning labeling on the closure ferrule. 

- Ampules containers are not recommended for paralyzing agents since they tend to be very small for the warning to be visible and usually ampules have similarity with other ampules, and many other disadvantages).

3.1.2. Vinca Alkaloids 

Vinca alkaloids must be labeled on primary and secondary packaging as "FOR INTRAVENOUS USE ONLY - FATAL IF GIVEN BY OTHER ROUTES" to clearly indicate the required route of administration.

3.2. Text Orientation 

The drug name should be able to be seen in a single line of vision. If the full drug name cannot be seen when the vial is upright, then the label should be oriented in a longitudinal fashion, in order to have the drug name in a single line of vision. Figure 39

3.3. Color Schemes

Match the design of the vial label to that of the carton.

Where the flip cap is colored, use the predominant differentiating color that has been used on the label and carton if possible.  Figure 40​

4.1. Secondary Packaging

Vary the design of the secondary packaging of similar products to enable easy identification. Pre-filled syringes that may be required during a medical emergency can be easily confused, especially when there is minimal differentiation on the outer packaging.

Consider the use of different colored components, for example, plungers or caps, to emphasize differences. Pharmaceutical products that come in a wide range of concentrations and doses can also be mistaken for each other. 

Outer packaging, once opened, should not be easily re-sealable and should clearly indicate that the pre-filled syringe has been removed to prevent a delay in treatment if the empty pack is placed back into stock. Figure 41

4.2. Text Orientation on Syringe

Orient text along the length of the syringe so critical information can be read holding it in the right hand, without rotating the syringe. When text is oriented around the syringe it necessitates a small font size which can be difficult to read. 

Invert text color or use a background color to prevent text showing through. 

Volume markings should always be visible and not covered by labels.

Figure 42​​

5.1. Text Positioning

The critical information should be placed at the top of the bag; this information (especially the drug name and strength/concentration) should be repeated at the bottom of the bag so that as the bag empties it can still be visualized.

Position the batch number and expiry date close together.

Invert the key information text to draw the eye to it.  Key information is lost in dense blocks of text.  Figure 43​

5.2. Font

The choice of font should be carefully considered to ensure adequate spacing between letters also the ink should not bleed. Use a san serif font as with other labels.

For multi-ingredients products, list the ingredients in table format if possible.  Figure 44

5.3. Bag Volume

For fluids that comes in different volume sizes, give emphasis to the volume of infusion. 

Vary other elements of the design to increase differentiation between labels. 

When listing ingredients on the infusion bags, the strength should be represented as quantity per container. Figure 45

5.4. Use of color

It is important to differentiate between identified high-alert infusions.

Use bold blocks of color that stand out and draw the eye to the critical information and warnings. 

Figure 46

5.5. Bag Unit

Where the strength of pharmaceutical product is expressed in mmol, it should be represented as mmol/container volume. 

5.6. Route of administration

Highlight the route of administration, particularly if it is different from the norm.  Figure 47  

5.7. Product differentiation 

Ensure there is an additional differentiator in addition to the text. For example, use color or, if this is not possible, vary the graphic components. Figure 48

5.8. Surface Finish

Use matte materials where possible to improve legibility. If materials used for the fluid bags and overwraps are reflective, the combination of the two materials can lead to impaired visibility of key information. Figure 49​​

1. Reporting of Medication Errors

If medication errors resulted from products packaging design or other product-related aspects, such incidents should be reported through the established pharmacovigilance systems of the marketing authorization holders. This includes reporting product-related medication errors such as poorly designed packaging, similarity between product names, design similarity between two or more products from the same company, and unclear labels.

These incidents should be reported to the SFDA in accordance with the Guideline on Good Pharmacovigilance Practices (GVP). Incidents shall be reported via the Vigilance System at https://ade.sfda.gov.sa/Organization/Login and in accordance with the Guidance for Medication Error Reporting.

2. Handling Corrective Actions

Companies have an ongoing responsibility to guarantee that each marketed product fulfills the applicable requirements, such as guaranteeing that its labeling isn't false or misleading in any specification. In case a marketed product’s proprietary name, packaging design or labeling causes or contributes to medication errors, the Company of that product should work expeditiously with SFDA to resolve the incident. In the event that the product does not comply with applicable requirements and the company is unwilling to address or resolve an issue voluntarily, the company may be subject to enforcement actions.

1. Elimination Of Ratio Expression

Quantity per milliliter (quantity/mL) must be indicated on single-entity injectable drug products, not as a ratio expression. 

Examples: Epinephrine Injection, 1:1000 must be expressed as 1 mg/mL. Epinephrine Injection, 1:10,000 must be expressed as 0.1 mg/mL. Isoproterenol Hydrochloride Injection, 1:5000 must be expressed as 0.2 mg/mL. Neostigmine Methylsulfate Injection, 1:1000 must be expressed as 1 mg/mL. 

Quantity per total volume on the main display panel of the label followed by quantity per milliliter (quantity/mL) enclosed by parentheses for single-entity injectable drug products more than 1 mL. The concentration of epinephrine will be expressed as a ratio when mixed with a local anesthetic.

Examples: Lidocaine Hydrochloride and Epinephrine Injection 1%/1:100,000 or Lidocaine Hydrochloride 1% and Epinephrine Injection 1:100,000.

1. Deletion of the Arabic Term معقم/ـة.

Based on reported incidents, the Arabic term مُعَقَّم, when used to denote a sterile dosage form, has been commonly misinterpreted by end-users as an indication of an antiseptic مُعَقِّم formulation. This misunderstanding poses a serious risk of improper use of sterile ophthalmic products.

To address this issue and ensure the safe and appropriate use of sterile ophthalmic preparations, it is mandatory to remove the Arabic term معقم/ة when referring to the sterile nature of the dosage form.

The used container/container closure system type should correspond to the intended route of administration and must not confuse or mislead the healthcare provider and/or patient regarding the correct route of administration. To ensure compatibility, the relevant information, as outlined in the 'Data Requirements for Human Drugs Submission' guidance, should be provided, including a mock-up of the packaging, three-dimensional on-shelf photographs, image of the container/closure system, and dosage form.​​​

• A guide to labeling and packaging injectable medicine, edition 1, 2008 National patient Safety Agency (NHS).

• A guide to the graphic design of medication packaging, 2nd edition, 2007, National Patient Safety Agency (NHS).

• A guide to the design of dispensed medicines, 1st edition, 2007, National Patient Safety Agency (NHS).

• The US Draft guidance, “Safety Considerations for Container Labels and Carton Labeling to Minimize Medication Errors”, April 2014.

• US FDA Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry_ Guidance for Industry (December 2020).

• USP General Chapter <7> Labeling - US Pharmacopeia