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Guidance for Products

Classification Version 2.1

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Guidance for Products classification

Version 2.1

Drug Sector Saudi Food & Drug Authority

Kingdom of Saudi Arabia

Please visit SFDA’s website at http://www.sfda.gov.sa/En/Drug for the latest update

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Document Control Version Date Author(s) Comments

1.0 04/06/2011 Products Classification Committee Initial draft for public comments

2.0 23/05/2012 Products Classification Committee Final

2.1 15/4/2014 Products Classification Committee Updated

Note: For most recent update please refer to annex 2.

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Table of Contents Document Control………………………………………………………………………………….3 Table of Contents…………………………………………………………………………………...4 Introduction…………………………………………………………………………………………..5 Products Suject for Drug sector Control…………………………………………………..6

I. Products subject for registration…………………………………….…………7 A. Drug products……………………………………………………………….7 B. Herbal products…………………………………………………………….8 C. Health products (R)……………………………………………………….9

II. Products subject for Listing………………………………………….................10 A. Health products(L)……………………………………………………….10 B. Cosmetics…………………………………………………………………….11 Borderline Products Definition……………………………………………………………………………………15 Policy for Borderline products Classification………………………………..15

Definition……………………………………………………………………………………15 Policy for Combined products Classification…………………………………15 Appendixes Appendix I Upper and lower concentration Limits table of

Vitamins and Minerals …………..…………………….……………………………...16 Appendix II…………………………………………………………………………………20

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1. Introduction

1.1. Background Most of the products can be easily classified Into drug, medical device,

cosmetic or food supplement and subsequently identifying which regulation these products should follow to get the marketing authorization. However, there are still many products which fall in the grey area or borderlines between these categories which makes it difficult to identify which marketing authorization scheme these products should follow. Therefore, the SFDA has developed this document, "Products Classification Guidelines" , to help the companies as well as the SFDA regulators to easily classify these products.

1.2. Scope This guideline describes the criteria for products classification which are

subject for Drug Sector Control. The following diagram shows the classification categories:

If the company could not identify the classification of their product, they could

submit a classification request along with the required documents described in the classification request guidance. It is important to note that the SFDA reserves the right to request information, material or defined conditions not specifically described in this document, in order to allow the administration to take the appropriate decision. In most cases the decision will follow this guidelines. However, there may be exceptions

Products Classification

Drug Sector Control

Subject for Registration

Drug Products Herbal Products

Health Products(R)

Subject for Listing

Cosmetics Health Products(L)

Food Sector Control

Medical Device Sector

Control

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where a particular products will not follow this guidelines. The SFDA is committed to ensuring that such requests are justifiable and decisions are clearly documented.

This document should be read in conjunction with the other relevant and applicable guidance documents. A copy of this document as well as the SFDA's application forms can be found on the SFDA website.

Health Products (R): Health Products subject for registration Health Products (L): Health Products subject for listing

2. Products Subject for Drug Sector Control

Products fall under the control of the drug sector are either should be registered or should be listed. The difference between these two categories will be explained in the following: 2.1. Products Subject for registration

Those products that need full assessment to ensure its quality, safety and efficacy. This category involves drug products, herbal products and high risk health products.

2.2. Products Subject for Listing Are those products that need assessment to lesser extent than that of

registration to ensure it safety. This category involves cosmetic products and low risk health products.

A detailed description about the products in these two categories will be in the

following:

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2.1. Products Subject for registration

2.1.1. Drug Products

A product would be considered as a drug if it falls within the following definition: A "drug product" means a substance or a combination of substances which may be used in or administered to human or animal beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action or to making a medical diagnosis;’

This definition will include the following products:

1. Products contain one or more vitamins and/or minerals with

concentrations above the upper concentration limit of vitamins and

minerals. The upper and lower concentrations limits will be calculated

according to the product total daily dose. (Appendix I)

2. Products contain any of the following substances:

• Salicylic acid in concentration More than 2%* (for rinse off

hair products contain salicylic acid, please see cosmetic

classification section).

• Hydroquinone.

• Ichthammol.

• Tretinoin (Retinoic acid) and its salts.

• Glucosamine .

3. Products contain medicinal claims that need high level of evidence

including but not limited to (treat, prevent, relieve symptoms, or to

cure, remedy or heal a specific disease or adverse condition of body or

mind (stress, anxiety and nervous tension), protect” or “avoid”

excluding claims that fall within the cosmetic definition.

4. Saline and sterile water that are intended for intravenous, irrigation or

ophthalmic use.

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5. Parenteral nutrition solution

6. Peritoneal dialysis solution

7. Blood derivative products

8. In vivo diagnostic agents including imaging agents.

9. Enema solutions products (rectal solution products)

10. Some pre-filled or pre-loaded devices intended to deliver a medicine.

11. An allergen tests are used internally and indicated in the diagnosis of

specific allergies.

12. Any product injected into the body(I.V., I.M. or S.C. …etc) either for

treatment, diagnostic or cosmetic purposes e.g. botulinum, hyaluronic

acid, collagen….etc.

13. Radiopharmaceuticals:

Radioactive substances administered internally will be considered as a drug regardless its purpose of use wither it is for treatment or diagnosis.

14. Medical gases (oxygen ، Nitrogen ، Nitrous oxide ،Carbon dioxide ، Helium ، Medical air & Carbon monoxide).

2.1.2. Herbal and Health products 2.1.2.1. Herbal product

A product would be considered as a medicinal herbal product when it falls

within the following definition: Finished, labeled products in pharmaceutical dosage forms that contain

one or more of the following: powdered plant materials, extracts, purified

extracts, or partially purified active substances isolated from plant

materials.

The number of herbs in the oral dosage form products should not

exceed Five herbs.

Homoeopathic preparations are not allowed to be marketed in

Saudi Arabia due to the lack of supporting evidence of its safety

and efficacy

2.1.2.2. Health product (R):

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A product would be considered as a health product subject for registration when it falls within the following definition:

Finished, labeled product in pharmaceutical dosage form which may

contain one or more of the following ingredients :

1. ِِAmino acid

2. Charcoal.

3. microorganism whole or extracted except a vaccine and antibiotics eg

Probiotics.

4. Products contain one or more vitamins and/or minerals with

concentrations equal or below the upper concentration limit provided

that non of these vitamins and/or minerals are below the lower

concentration limit. The upper and lower concentrations limits will be

calculated according to the product total daily dose. (Appendix I)

5. A lipid, including an essential fatty acid or phospholipids e.g. omega 3.

6. Natural enzyme products.

7. Sulfur in concentration higher than 2 %.

8. Oral, Nasal or ear Saline solution products e.g. ear drops, nasal spray,

nebulizers.

9. Tar

10. Electrolyte products (flavored or not) (powder or liquid) other than

those used as fluid replacement for athletes.

11. Anti-lice products containing chemical ingredients 12. Antiseptic products for human use containing any ingredients of the

following:

• Benzalkonium • Benzethonium • Chlorhexidine • Chloroxylenol • Methylbenzethonium • Povidone-iodine • Hydrogen peroxide (H2O2)

Note: Products used for cosmetic purposes and contain one of the above ingredients within the concentrations recommended by the GSO standards for cosmetic products will be classified as cosmetic.

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2.2. Products Subject for Listing:

2.2.1. Health Products (L):

To classify a product as health product subject for listing, it must meet one or more of the following criteria and/or type of products:

1. Must NOT be an isolate of a medicinal herbal substance. 2. Must NOT be a type of product that needs to be sterile, such as eye drops. 3. Must NOT be in a capsules, pills and tablets.

4. Must contain only permitted excipient including coloring, flavoring and fragrance ingredients.

5. Must comply with the labeling requirements of listed products. 6. Have no inappropriate indication(s) for listed products. 7. Number of herbs should not exceed five herbs. 8. Products containing medicinal herbs (such as Listed in Appendix 1) that are not in

its natural form and have gone through any manufacturing process such as grinding, extraction, packaging or any other manufacturing process.

9. Aromatic and medicinal herbal oils that contain one or more of oils that are extracted from medicinal plants that have non nutritional claims and used internally (Appendix 1).

10. Medicated throat lozenges which consist only of volatile oils, ascorbic acid (or its

salts) and at least menthol with no unacceptable claim. The concentration of the individual ingredients (menthol, eucalyptus oil and Ascorbic acid) must not exceed the maximum value as follows:

o Menthol 5 - 20 mg o Eucalyptus oil 0.2 - 15 mg. o Ascorbic acid: 100 mg

11. Topical products containing organic acids (Alpha-hydroxy acids (AHAs)) in total

concentration of organic acids more than 10% .

N.B.: All extracts or isolated active substance(s) of herbal substance(s) in a form like capsules, pills, tablets and syrup are subject for registration as Herbal Product.

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12. Alcohol hand sanitizers included this ingredient and concentration (Ethanol 60-80% & Isopropanol 60-70%).

13. Topical patches, creams, ointments and gels containing counter irritant ingredient as an externally applied substance that causes irritation or mild inflammation of the skin for the temporary relieve of pain in muscles or joints by reducing inflammation in deeper adjacent structures (these products should comply with the Canadian Counterirritant monograph :

http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=counter 14. Medicated Skin Care Products containing urea in a concentration greater than the

concentration recommended by the GSO standards for cosmetic products.

15. Energy drink product these products should comply with the energy drinks

recommendations (GSO 1926/2009).

16. Powder products to provide nutritional support to athletes and persons who

exercise (“powder sports supplements”).

17. toothpaste products contain one of the following ingredients:

o Triclosan o Chlorhexidine o Cetylpyridinium o Cetrimide

18. Anti-lice products containing natural source oils or ingredients 19. Insect repellents in direct contact with human skin.

2.2.2.Cosmetic Products: A product would be considered as cosmetic if it falls within the following

definition:

(Any substance or preparation intended to be placed in contact with the

various external parts of human body (epidermis, hair system, nails, lips, and

external genital organs) or with the teeth and the mucous membranes of the

oral cavity with a view exclusively or mainly to cleaning them, perfuming

them, changing their appearance and/or correcting body odours and/or

protecting them or keeping them in good condition).

This definition is applicable on the following cosmetic products:

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– Creams, emulsions, lotions, gels and oils for the skin (hands, face, feet,

etc.).

– Face masks (with the exception of peeling products).

– Tinted bases (liquids, pastes, powders).

– Make-up powders, after-bath powders, hygienic powders, etc.

– Toilet soaps, deodorant soaps, etc.

– Perfumes, toilet waters and eau de cologne.

– Bath and shower preparations (salts, foams, oils, gels, etc.).

– Depilatories.

– Deodorants and anti- perspirants.

– Hair care products:

* hair tints and bleaches,

* products for waving, straightening and fixing,

* setting products,

* cleansing products (lotions, powders, shampoos),

* conditioning products (lotions, creams, oils),

* hairdressing products (lotions, lacquers, brilliantine’s).

– Shaving products (creams, foams, lotions, etc.).

– Products for making up and removing make-up from the face and eyes.

– Products intended for application to lips.

– Products for care of teeth and mouth (mouthwash products containing

alcohol are considered as banned products).

– Products for nail care and make-up.

– Products for external intimate hygiene which do not contain ingredients

that have antimicrobial activity.

– Sunbathing products.

– Products for tanning without sun.

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– Skin-whitening products (except Hydroquinone containing products).

– Anti-wrinkle products.

– Eye decorative cosmetic products (Eye shadow, Mascara, brows, lids,

pencil, lashes, cream and athmad (Al-kohol)).

All cosmetic products should comply with the following: 1. Free of prohibited substances according to GSO 1943/2009 in addition

to the following substances: a. Tretinoin (Retinoic acid) and its salts (Not permitted at any

concentration) b. Hydroquinone (Dihydroxy Benzene): c. Triclosan (Not permitted at any concentration) d. Aspestos

2. Compatible with restricted substances according to GSO 1943/2009 in

addition to the following restricted substances: a. Vitamin A (Retinol) and its esters retinyl acetate, retinyl

palmitate (Permitted at concentrations equal to or less than 1%)

b. Sulfur (Permitted at concentration equal or less than 2%)

c. Urea (permitted at concentration equal to or less than 10%,

Cosmetics intended to be diluted in bath water may contain

levels exceeding 10% urea)

d. Salicylic acid (permitted at different concentrations

according to its role as shown in the following table):

Role Salicylic Acid permitted concentration

Active Ingredient ≤ 3% in rinse off hair products

≤ 2% in other products

Preservative < 0.5%

e. Zinc oxide permitted at concentration less than 25% (unless

if it is used for medical condition, in this case it will be

classified as drug).

f. Alpha-hydroxy acids (AHAs):

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(including, but not limited to citric acid (77-92-9), glycolic acid (79-14-1), lactic acid (50-21-5), malic acid (6915-15-7), glycolic acid + ammonium glycolate, alpha-hydroxyethanoic acid + ammonium alpha-hydroxyethanoate, alpha-hydroxyoctanoic acid, alpha-hydroxycaprylic acid, hydroxycaprylic acid, mixed fruit acid, triple fruit acid, tri-alpha hydroxy fruit acids, alpha hydroxy and botanical complex, L-alpha hydroxy acid and glycomer in cross-linked fatty acids alpha nutrium)

a. Permitted at total concentrations equal to or less than 10%, with a pH equal to or greater than 3.5

b. The inner and outer labels of all leave-on skin products containing AHAs at concentrations equal to or greater than 3% shall carry cautionary statements in Arabic and English to the effect: "Use only as directed", "Avoid contact with the eyes", "If irritation persists, discontinue use and consult a physician", "It is recommended that prior to exposure to the sun, users cover areas where AHAs have been applied with sunscreen", "Contact of the ----product with the skin must be of limited frequency and duration."

c. Preparations intended to be diluted in bath water may contain levels of citric acid exceeding 10%.

3. Should not come in capsule or tablet dosage forms. 4. Cosmetic products that come in ampoule and vials should contain the

following instructions in Arabic and English: e. For external use only. f. Avoid contact with eyes g. Open with Caution

5. Free of any medical claims, examples of accepted claims: a. Cleaning. b. Perfuming. c. Changing their appearance. d. Correcting body odours. e. Protecting or keeping them in good condition. f. Any claim fall under cosmetic definition.

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o Borderline Products: o Definition:

Products which are difficult to determine whether they are considered as drugs, medical device, herbal or health products are called borderline products.

o Policy for Classification: These products will be assessed by the classification committee in the drug sector to identify its category or classification. The committee will take its decision based on this guidelines as well as the international practices. the classification committee could forward the request to the SFDA superior committee for classification along with its recommendation to take the appropriate decision.

o Combined Products:

o Definition: A product comprised of two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single entity.

o Policy for Classification: Once any of the SFDA sectors have a classification or marketing authorization request for such a product, the sector should forward the request to the SFDA superior committee for classification to determine the leading sector for the premarket review based on the product’s primary mode of action. The leading sector should collaborate with the related sectors to identify the requirements to approve such products. The leading sector and the related sector should cooperate together in the reviewing process to ensure the quality, safety and efficacy of the product.

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Appendix I

Table for The Upper and lower Concentrations Limits of Vitamins and Minerals

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Life Stage Group Vitamin A

(μg RAE/day) Vitamin C (mg/day)

Vitamin D (μg/day)

Vitamin E (mg/day)

Vitamin K1 and K2 (μg/day)

LL UL LL UL LL UL LL UL LL UL Infants 0-12 mo 30 600 - - 0.2 25 - - - -

Children 1-3 y 30 600 2.2 400 0.2 25 0.6 179 3 30

4-8 y 30 900 2.2 650 0.2 25 0.6 179 3 55

Adolescents 9-13 y 30 1700 2.2 1200 0.2 25 0.6 179 3 60

14-18 y 65 2800 6.0 1800 0.8 25 1.0 179 6 75

Adults ≥ 19 y 65 3000 6.0 2000 0.8 25 1.0 179 6 120

Life Stage Group Thiamine (mg/day)

Riboflavin (mg/day)

Niacin Or Niacinamide

(mg/day)

Vitamin B6 (mg/day)

Folate (μg/day)

LL UL LL UL LL UL LL UL LL UL Infants 0-12 mo - - - - - - - - - -

Children 1-3 y 0.04 100 0.04 100 0.6 10 0.05 30 15 300

4-8 y 0.04 100 0.04 100 0.6 15 0.05 40 15 400

Adolescents 9-13 y 0.04 100 0.04 100 0.6 20 0.05 60 15 600

14-18 y 0.07 100 0.08 100 1.0 30 0.1 80 30 800

Adults ≥ 19 y 0.07 100 0.08 100 1.0 500 0.1 100 30 1000

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Life Stage Group Vitamin B12

(μg /day)

Pantothenic acid

(mg/day)

Biotin (μg/day)

Choline (mg/day)

Calcium (mg/day)

LL UL LL UL LL UL LL UL LL UL Infants 0-12 mo - - - - 0.2 25 - - - -

Children 1-3 y 0.09 1000 0.2 500 1 500 0 1000 65 1500

4-8 y 0.09 1000 0.2 500 1 500 0 1000 65 1500

Adolescents 9-13 y 0.09 1000 0.2 500 1 500 0 1000 65 1500

14-18 y 0.14 1000 0.4 500 1.8 500 0 1000 65 1500

Adults ≥ 19 y 0.14 1000 0.4 500 1.8 500 0 1000 65 1500

Life Stage Group

Chromium (μg/day)

Flouride (mg/day)

Iodine (μg/day)

Iron (mg/day)

Magnesium (mg/day)

LL UL LL UL LL UL LL UL LL UL

Infants 0-12 mo - - - - - - 0.6 40 - -

Children 1-3 y - - - 0.7 6 133 0.6 40 12 65

4-8 y - - - 1 6 200 0.6 40 12 110

Adolescents 9-13 y - - - 2 6 400 0.6 40 12 350

14-18 y - - - 3 14 800 1.4 45 20 350

Adults ≥ 19 y 2.2 500 - 4 14 800 1.4 45 20 500

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Life Stage Group Manganese

(mg /day)

Molybdenum (μg/day)

Phosphorus (mg/day)

Selenium (μg/day)

Zinc (mg/day)

LL UL LL UL LL UL LL UL LL UL Infants 0-12 mo - - - - - - - - 0.2 2

Children

1-3 y - - - - 62 2000 - - 0.4 7

4-8 y - - - - 62 2000 - - 0.4 12

Adolescents

9-13 y - - - - 62 2000 - - 0.4 23

14-18 y - - - - 62 2000 - - 0.7 34

Adults ≥ 19 y 0.13 9 2.5 2000 62 2000 3.5 400 0.7 50

Life Stage Group Potassium (mg/day)

Sodium (g/day)

Chloride (g/day)

Boron (μg/day)

Copper (μg/day)

LL UL LL UL LL UL LL UL LL UL Infants 0-12 mo - - - 0.12 - 0.18 - - - -

Children 1-3 y - - - 1.0 - 1.5 - - 35 700

4-8 y - - - 1.2 - 1.9 - - 35 2500

Adolescents 9-13 y - - - 2.3 - 2.3 - - 35 4000

14-18 y - - - 2.3 - 2.3 - - 65 6500

Adults ≥ 19 y - 100 - 2.3 - 2.3 - 700 65 8000

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Life Stage Group Nickel

(μg /day)

Vanadium (μg/day)

Lutein (mg/day)

Beta-carotene

(μg/day)

L-Methionine

(mg/day)

LL UL LL UL LL UL LL UL LL UL Infants 0-12 mo - - - - - - 60 1200 - -

Children 1-3 y - - - - - - 60 1200 - 1000

4-8 y - - - - - - 60 1800 - 1000

Adolescents 9-13 y - - - - - - 60 3400 - 1000

14-18 y - - - - - - 130 5600 - 1000

Adults ≥ 19 y - 350 - 182 - 10 130 6000 - 1000

Life Stage Group Inositol

(mg/day) Cobalt

(μg/day)

LL UL LL UL Infants 0-12 mo - - - -

Children 1-3 y - 650 0.004 44

4-8 y - 650 0.004 44

Adolescents 9-13 y - 650 0.004 44

14-18 y - 650 0.006 44

Adults ≥ 19 y - 650 0.006 44

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Annex 2:

What's New in The Guidance for Products classification (version 2.1)? The following table shows statements which added, deleted or replaced to the past

version 2 May 23, 2012:

Section Added statement 2.2.3. Drug Products

Point no, 12

(I.V., I.M. or S.C. …etc) either for treatment, diagnostic or cosmetic purposes e.g. botulinum, hyaluronic acid, collagen….etc.

2.2.4. Drug Products

Point no, 14

Medical gases (oxygen ، Nitrogen ، Nitrous oxide ،Carbon dioxide ، Helium ، Medical air & Carbon monoxide).

Health product (R)

Point no, 10

Electrolyte products (flavored or not) other than those

used as fluid replacement for athletes.

Health product (R) Point no, 11

Anti-lice products containing chemical ingredients

Health product (L)

11. Medicated Skin Care Products containing urea in a concentration greater than the concentration recommended by the GSO standards for cosmetic products.

20. Anti-lice products containing natural source oils or ingredients

21. Insect repellents in direct contact with human skin.

2.2.5. Cosmetic

Products: prohibited substance

Asbestos

Health product (L)

Point no, 14

Medicated Skin Care Products containing urea in a concentration greater than the concentration recommended by the GSO standards for cosmetic products.

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Section update statement Health

product (L)

Point no, 6

Products containing medicinal herbs (such as Listed in Appendix 1) that are not in its natural form and have gone through any manufacturing process such as grinding, extraction, packaging or any other manufacturing process

Health

product (L)

Point no, 7

Aromatic and medicinal herbal oils that contain one or more of oils that are extracted from medicinal plants that have non nutritional claims and used internally (Appendix 1).

Health

product (L) Point no, 8

Medicated throat lozenges which consist only of volatile oils, ascorbic acid (or its salts) and at least menthol with no unacceptable claim. The concentration of the individual ingredients (menthol, eucalyptus oil and Ascorbic acid) must not exceed the maximum value as follows:

o Menthol 5 - 20 mg o Eucalyptus oil 0.2 - 15 mg. o Ascorbic acid: 100 mg

Health

product (L) Point no, 9

Alcohol hand sanitizers included this ingredient and concentration (Ethanol 60-80% & Isopropanol 60-70%).

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