SFDA has strict labelling and packaging requirements that companies have to comply with during the submission of the registration application. Once this application is approved, the approved labelling information must not be altered even in the minimum way, so the products stay in compliance and avoid rejection and the clearance port or withdrawal from the market.
This article will go through the labelling requirements for drugs, supplements, medical devices, and food products.
There are specific requirements that have to be applied to all the drug artwork components including carton, label, foil, in addition to the leaflet insert (patient Information LLeaflet PIL) and the Summary of Product Characteristics SPC. We will outline here the high-level requirements for each of the abovementioned components that companies have to apply since they are one of the main drug registration requirements in Saudi Arabia.
Outer and Inner Packaging
Name of the medicinal product
Product description to be displayed on more than three non-opposing faces of six faces of the box. It should be written in English and Arabic.
Statement of the active substance(s)
The expression of the active substance should be presented qualitatively and quantitatively per dosage unit. It should be written in English and Arabic.
Statement of Indication
The product indication should be highlighted on the pack. e.g. for the treatment of, the prevention of, etc
List of excipients
Those excipients with recognised effects or actions should be expressed qualitatively. If the medicinal product is a parenteral, a topical or an eye preparation, or if used for inhalation, all excipients must be stated.
Pharmaceutical form and contents
The contents by weight, volume or by number of doses or number of units of administration should be mentioned (e.g. 10 tablets, 100 mL, etc.).
Method and route(s) of administration
Method of administration and directions for proper use of the medicinal product should be clearly stated, e.g. “Shake well before use. For the direction of use, it can be referred to (see enclosed leaflet)
The special warning should be highlighted on the label eg Protect from sunlight, Keep out of sight and reach of children, For external use only
The product storage condition should be mentioned e.g. Store below 250C or Store below 300C. In-use stability should be mentioned for multidose products eg Shelf life after the first opening is one month, two months, three months etc. It has to reflect what is stated in the SFDA stability study.
Manufacturer and MAH
Manufacturer and Marketing Authorization Holder Name and Address should be clearly mentioned.
Blisters or strips
Name of the medicinal product
The name and strength of the product should appear over each blister pocket; if the size of the pockets is too small, the information should be repeated in a pattern across the entire strip. It is required in English and Arabic.
Name of the marketing authorisation holder
Brand name only is sufficient.
Manufacturing and Expiry dates
Dates should be expressed either as e.g. 02/2010 or Feb 2010.
The batch (lot) number and expiry date should be at the end of each blister strip.
Summary of Product Characteristics SPC
Name of the medicinal product, strength, and pharmaceutical form.
Qualitative and Quantitative composition
The expression of the active substance should be presented in a dose per unit. A standard statement should be included for excipients, i.e. ‘For a full list of excipients, see section ‘’list of excipients’’.
The product dosage form should be mentioned, e.g. Film-coated tablet, Sustain release tablet etc, along with the description of the dosage form. In case the tablets are designed with a scoreline, information should be given, whether it is just to facilitate breaking or to divide the pills into equal doses.
The indication should define the target disease or condition for treatment or prevention and its indication in adults, neonates, infants, children, and adolescents of age (months, years).
Posology and method of administration
Dose recommendations should be specified per dose interval for each category where appropriate (specify age/weight/body surface area of subsets of the population as appropriate. The information on special populations like the elderly patients, renal impairment, hepatic impairment, and pediatric population should be provided. Also, precautionary measures for handling and administering the product should be provided.
The situation of medicinal products which must not be given for safety reasons i.e hypersensitivity to the active substance or to any of the excipients.
Special warning and precautions for use
Information on specific risk, specific risk minimisation measures, adverse reactions, safety information,
Clinical interaction study (in-vivo), Pharmacodynamic interaction, Pharmacokinetic interaction.
Fertility, Pregnancy, and lactation
Recommendations for use in pregnant, lactating women, and women of childbearing potential should be in view of the clinical study, non-clinical study and pharmacological activity.
Effects on ability to drive and use machines
Summary of the safety profile, adverse reaction, and national authority address for reporting any side effects.
Effect of different dosing levels taken accidentally, by mistake or by suicide attempts.
The contents by weight, volume or by number of doses or number of units of medicinal product administration should be mentioned (e.g. 10 tablets, 100 mL, etc.).
- List of excipients
- Shelf life
- Special precaution for storage
- Nature and contents of the container.
Special precautions for disposal and handling
Special requirements for disposal if not ‘’no special requirements’’ can be mentioned. The disposal should be in accordance with the local requirements.
Marketing Authorization Holder
Marketing Authorization Number
Date of first Authorization/Renewal of the Authorization
Date of revision of the text
Patient Information Leaflet PIL
What (invented name) is, and what it is used for
Invented name, strength, pharmaceutical form, the active ingredient, therapeutic indication, and benefit of using this medicine.
Before you take or use the product
Contraindication, appropriate precautions for use/special warnings, interactions with other medicines/food/drinks, information for use in pregnant or breastfeeding women, information on fertility, driving and using machines, and excipient’s warnings.
How to take or use the product
Dosage, Method and/or route(s) of administration, Frequency of administration, Instructions for proper use, Duration of treatment, overdose, irregular use of medicine,
Possible side effects
Description of side effects, additional side effects in children and adolescents.
How to store the product name
Special direction and precaution during storing, and storage conditions.
Active substance(s) and excipient(s) information, Pharmaceutical form, nature and contents of container, Name and address of the marketing authorization holder and of the manufacturer responsible for batch release, the revision date of PIL, National authority address for reporting any side effect.
Medical Device Labelling
SFDA Medical Devices Labelling and packaging requirements for device labels and instructions for use (IFU) are mandatory to comply with in your submission of SFDA medical device registration applications, it is applicable for low-risk and high-risk (MDMA) medical devices. The term Labelling is a collective term comprising:
- the label,
- Instruction for Use (sometimes referred to as the operator’s manual), and
- Any other information that is related to identification, technical description, intended purpose and proper use of the medical device,
The term Label describes written, printed, or graphic information that is:
- Affixed to or appearing on the medical device itself (including electronic display)
- On the packaging of:
- Each unit (wrapper)
- Multiple devices (containers)
- On a package insert (is used where it is impractical or inappropriate to affix a label directly on the medical device itself. Impractical means where physical constraints prevent this happening).
The primary purpose of labelling is to:
- Identify the medical device and its manufacturer,
- Describe the device’s intended use and performance,
- Describe how the device should be used, maintained, and stored, and
- Provide information on any residual device risks, warnings, limitations or contraindications.
Instructions For Use (IFU)
The term “Instructions for Use (IFU)‟ means the information provided by the manufacturer to inform the device user:
- Of the medical device’s intended purpose and proper use.
- Of any precautions to be taken.
IFU may not be needed or maybe abbreviated for devices if they can be used safely and as intended by the manufacturer without any such instructions for use (e.g., Optical lenses, walking sticks or simple wound dressings).
Language of Labelling
Where the user of the medical device is:
- Likely to be professionally qualified, the labelling shall be in English.
- A layperson, the Label and IFU shall be, wherever feasible, in both Arabic and English. Where this is not feasible, the language used on the LABEL and IFU shall be Arabic.
In both situations, the text shall be written in terms readily understood by the intended user, commensurate with their technical knowledge, experience, education, or training.
Language of Manufacturer’s Instructions
Instructions for the handling, storage, transportation, installation, maintenance, and disposal of the medical devices shall be in English and, where justified, in Arabic. The text shall be written in terms readily understood by the intended user, commensurate with their technical knowledge, experience, education or training where persons without medical qualification may undertake such work. Where the device is designed to be used by laypersons, instructions for the handling, storage, transportation, and maintenance of the medical devices shall be in Arabic and English.
Medium of Labelling
Labels shall be provided in a human-readable format but may be supplemented by machine-readable forms, such as radio-frequency identification (RFID) or bar codes.
Content of Labelling
Name of device
Product Trade or Brand Name be printed on the label. Likewise, the product Model no is printed on the label.
Name and address of the manufacturer
The manufacturer’s name & address be printed on labels, and it must match letter by letter with the address details as mentioned in the submitted AR agreement & subsequent AR license. Any discrepancy in address details would lead to the return of the submitted application to SFDA & thus would create complications in acquiring medical device marketing authorisation.
Legal Manufacturer in OEM /OBL Cases
OEM is the abbreviation of Original Equipment Manufacturer, while OBL is Own Brand Labelling.
The legal manufacturer in OEM / OBL cases, where the EU jurisdiction has been selected as the basis of the MDMA application, SFDA considers the manufacturer’s name, which is next to the “Manufacturer Symbol” on the labelling as the legal manufacturer. If this is not applicable, the following documents should be submitted to SFDA:
- Copy of conformity assessment certificates based on the used conformity assessment route (i.e., CE certificate, DE certificate, Production Quality Assurance Certificate…etc.)
- Copy of products‟ Declaration of Conformity.
- Copy of labelling (including the Instruction for Use)
- Most recent Audit report (if applicable)
Device Power Supply
Where the device is connected to an a/c power supply, an indication of the nominal frequency (60 Hertz) and the voltage values with their tolerances for which the devices have been designed
If the device is an IVD medical device, an indication that the device is for in vitro diagnostic use.
Where applicable, an indication of any special storage and handling condition that applies.
Warning or Precautions
Any warnings, precautions, limitations, or contra-indications.
Batch or Lot Number
The batch code/ LOT number or the serial number allows post-market compliance actions to be applied if there is a need to trace or recall the device. However, for accessories of IVD medical devices, this may be substituted with a control number, and for software, it shall be replaced with a version number.
An unambiguous indication of the date until when the device may be used safely (e.g., on devices supplied sterile or single-use disposable devices), where this is relevant.
Where relevant, an indication of the net quantity of contents, expressed in terms of weight or volume, numerical count, or any combination of these or other terms which accurately reflect the contents of the package.
Single or multiple Use
If the device is intended for single-use, an indication of that fact.