The Saudi Food and Drug Authority (SFDA) has laid down strict regulations regarding pharmacautical labeling. In this article, we will look at the key requirements for pharmaceutical products’ primary and secondary packaging, along with Patient Information Leaflets (PIL), and how to comply with Saudi Arabia drug laws.

‍Disclaimer: This blog post derives information from the SFDA website and is updated as of October 14, 2024. Please refer to official Government sources for updated information regarding pharmaceutical labeling requirements in Saudi Arabia. Artwork Flow is a label compliance software and cannot provide legal advice or services regarding labeling.

What information must appear on secondary packaging?

Secondary packaging is the outer container of drugs and it protects the primary packaging. Your secondary packaging conveys important information to patients, including dosage, usage instructions, and warnings.

Here is what the Saudi FDA mandates for secondary packaging in pharmaceutical products.

Product name

Display the generic and trade names of the medicine on the secondary packaging. Any critical information including the product's trade and generic names and dosage should be visible in at least 3 non-opposing faces of the box.

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Dosage form

Specify the dosage form of the drug clearly. Common dosage forms include tablets, capsules, syrups, and more.

Strength or concentration

Show the amount of active ingredient present in a specific dosage form to ensure consumers take the correct dosage of medication. If the same product comes in different strengths, ensure you use the same measurement unit throughout and that the packaging for each strength is visually differentiated through color and typography.

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List of excipients

Mention any inactive ingredients (excipients) that have any known effect when consumed. However, if the medication is parenteral, topical, inhalable, or for the eyes, list every single excipient in the packaging.

Route and method of administration

Specify the method and technique by which the medication is to be taken or applied. 

For example: "Shake well before use. For oral administration only."

Net quantity

Display the total volume of the drug in grams, milligrams, milliliters, or units, depending on the dosage form.

Manufacturing and expiry dates

Represent dates with a three-letter abbreviation of the month or a two-digit month followed by a four-digit year. For example, a product with an expiry of October 2026 would denote its expiration date on the packaging as OCT 2026 or 10/2026. 

Marketing authorization holder (MAH)

Mention the name and address of the marketing authorization holder on the label.

Warning statements

Add warning statements where required to inform consumers about potential risks or precautions associated with the drug.

Examples:

• "Keep out of reach of children"
• "May cause drowsiness or dizziness"

Indications for 

Clearly state the intended indication of the product. This can be included in the outer or inner packaging or even on patient information leaflets (PIL). 

Storage conditions

Add instructions for proper storage to ensure potency and safety of the drug.

Typography recommendations for secondary packaging under the SFDA

• Use the largest font size possible for each packaging to ensure readability.
• Use both upper and lower case letters throughout the packaging to maintain visual hierarchy.
• Do not italicize letters unless no other form of emphasis is available. 
• Use bold or semi-bold formatting and legible typefaces such as Arial, Helvetica, or Universe.
• Ensure there is a strong contrast between the type and background color.

What information must appear on primary packaging?

Primary packaging includes blisters or strips that are in direct touch with the medicine. This packaging needs to protect the medication and also inform the customer about the medicine they are consuming.

Here are the SFDA’s requirements for blister packs and other primary packaging.

Product name

The name of the product and its strength needs to go over every single blister pocket in both English and Arabic. If the pockets are too small to carry this information, repeat it in a pattern across the entire strip. 

Marketing authorization holder

Add the brand name to the packaging.

Manufacturing and expiry dates

Add the manufacturing and expiration dates with either a three-letter abbreviation of the month or a two-digit month followed by a four-digit year.

Batch number

Add the batch number and expiry date to each end of the blister strip.

Days of the week (optional)

For medication taken every day, you also have the option to add calendar days over the backside of blister pockets when packaged in strips in multiples of 7.

Typography recommendations for blister pockets under the SFDA

Ensure the following points are implemented to maintain legibility and readability:

• The type should be in bold or semi-bold.
• The font size should be big enough to be readable on the blister pack.
• The type color should be in high contrast against the background color to ensure readability.

Patient Information Leaflet (PIL)

A PIL is a leaflet that comes with a medicine and provides information about the medicine. The PIL informs patients about their medication, side effects, and directions of use amongst other things.

Under the SFDA Saudi, these are the labeling requirements for PILs.

The product and its usage

List the product name, active substances, and its pharmacotherapeutic group in simple language that can be understood by patients. Also include the therapeutic indications and the benefit of using this medicine.

What the consumer needs to know before using the medicine

This is where you elaborate on things the consumer needs to know before starting a new medication. Here are the points you need to include:

• Contraindications
• Warnings and precautions
• Interactions with other medicines and herbal or dietary supplements
• Interactions with certain foods and drinks
• Use during pregnancy and breastfeeding
• Driving and operating machinery
• Excipient warnings

Usage instructions

Add details about how to take or use the medicine, including:

• Dosage
• Method of administration
• Frequency of administration
• Instructions for proper use
• Treatment duration

Also include information on overdosage, irregular use, and interrupted treatments here. 

Possible side effects

List the most serious side effects first along with clear instructions on what actions need to be taken. E.g., “If you experience any of the following serious side effects, stop taking [product name] and seek medical attention immediately.”

Side effects outside of the more serious ones should be arranged by frequency.

Storage information

Add directions on how to store the product. For example, “keep out of reach of children.”

Further information

Mention the active substances and other ingredients, pharmaceutical form, shape, color, and other physical properties, MAH, and leaflet approved date. Also include the address of the National Pharmacovigilance Centre (NPC) to report side effects. 

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ComplyAI is used by brands like Sadafco, Hovid, and GoodyCo to achieve total compliance with local regulations. Talk to us today if you’d like to see it in action — no obligation at all!