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Pharmaceutical Product Classification

Guideline

National Health Regulatory Authority (NHRA)

Kingdom of Bahrain

January 2018 Version 2.0

Chief of Pharmaceutical Product Regulation:

Dr / Roaya Al Abbasi Date:

NHRA CEO Approval:

Dr / Mariam Al Jalahma Date:

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Document Control

Version Date Author(s) Comments

1.0 2/3/2013 Pharmaceutical Product Regulation Office Final

2.0 31/12/2018 Pharmaceutical Product Regulation Office Final

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Table of contents

Item Page

1. Introduction 4 2. Scope 5 3. Products Subject for Pharmaceutical Products Regulation Office

Classification 5

3.1 Product subject to registration with PPR 6 3.1.1 Medicine 6 3.1.2 Health product 7

3.1.2.1 Herbal product 7 3.1.2.2 Combination product (Herbal/Vitamin and

Mineral/Others) 8

3.1.2.3 Others 8 3.1.3 Alternative and complementary medicine 10

3.2 Product not subject to registration with PPR 10 3.2.1 Food supplement 10 3.2.2 Cosmetic product 10 3.2.3 Combined medical device 12

4. Classification query 13 Annexes

Annex I Tolerable Upper Intake Level (UL) for Vitamins and Minerals

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Annex II Words or phrases that in context may suggest or imply a medical claim about a product

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Annex III List of reference competent authorities

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References 18

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1. Introduction

Guideline documents are meant to provide assistance to industry and professionals on how to comply with governing statutes and regulations. Guideline documents also provide assistance to staff on how NHRA mandates and objectives should be implemented in a manner that is fair, consistent and effective.

The purpose of this guideline is to provide clear definitions of the products for which the Pharmaceutical Products Regulation Office (PPR)* of the NHRA has responsibility and to provide an understanding of the factors that guide classification decisions by NHRA in relation to any pharmaceutical products for human use.

Before a pharmaceutical product can be placed on the market in the Kingdom of Bahrain, an application must be made for a license to the NHRA. Such applications should contain the data necessary to support the quality, safety and efficacy for the product. These data are reviewed by the NHRA and a conclusion reached based upon the likely balance of the benefits versus risks associated with the product. As indicated above, the license must be granted prior to the product being placed on the market. The NHRA requires that the interests of consumers and users of pharmaceutical products should be protected, notably in the following areas:

- A pharmaceutical product should be of appropriate quality such that its contents and its

pharmaceutical performance should conform to acceptable standards,

- The risk of using the product should be acceptable and reasonable, taking into account that the use of any medicine carries a risk, which should be considered in the light of the likely benefit,

- There should be a demonstrable benefit for pharmaceutical products. If a medicinal claim is

made, the consumer is entitled to expect a benefit.

- Any product registered as food supplement in country of origin (reference competent authority, refer Annex III) will be considered as such in the Kingdom of Bahrain, with condition to Annex II.

This document should be read in conjunction with other applicable guideline documents.

* PPR: Pharmaceutical Product regulation is the responsible office for medicine licensing at NHRA

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2. Scope

This guideline defines those pharmaceutical products which are subject to NHRA control and outlines

the procedure for classification of such products.

Listed below are the product categories accepted for classification:

2.1 Medicine

2.2 Health Product

a. Herbal product

b. Combination products ( Herbal/Vitamins and Mineral/Others)

c. Others

2.3 Alternative and Complementary Medicine

a. Homeopathic medicine

b. Ayurvedic medicine

c. Others

2.4 Others

a. Combined medical device

b. Food supplement

c. Cosmetic

Any product registered by NHRA should mention the standard statement “To consult health care

professional before use in case of pregnancy and or lactation or under medication”.

PPR, upon classification shall issue an official letter of product classification. A proper procedure of

product registration is to be followed thereafter.

3. Products Subject for Pharmaceutical Products Regulation Office Classification

Application for classification of a pharmaceutical product is accepted by the PPR office of NHRA.

However, control and registration of the product are defined by the pharmacy law 18 of the year 1997.

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3.1. Products subject for registration with PPR

Products that are listed under the control of Pharmaceutical Products Regulation Office should be

registered. These products need full assessment to ensure their quality, safety and efficacy. This

category involves medicines, herbal products and high risk health products.

3.1.1. Medicine

A medicine is defined as follows:

Any substance or combination of substances presented as having properties for treating or

preventing disease in human beings; or

Any substance or combination of substances which may be used in or administered to human

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 intake

level of vitamins and minerals.[Annex I/USP Dietary Supplement Compendium (USP DSC)].

2. The adult upper intake level (daily dose) will be followed as per USP DSC (following the countries

listed in USP DSC)/reference countries (Annex III). The upper intake level will be calculated as per

country of origin. If the country of origin is not mentioned in the USP in such cases NHRA

classification upper intake level as per annex I will be followed e.g. If the product is from Japan then

limits as per USP DSC will be considered.

3. If the upper intake level is not detectable/not mentioned in USP DSC, then NHRA classification upper

intake level (Annex I) will be considered.

4. Products containing vitamins and/or minerals for infants (between 0 and 12 months) are considered

to be medicine.

5. Products contain any of the following substances:

a) Salicylic acid in concentration more than 3% (for rinse off hair products containing salicylic

acid, refer to GSO Standard).

b) Hydroquinone.

c) Icthammol.

d) Tretinoin (Retinoic acid) and its salts.

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e) Red yeast rice

6. Saline and sterile water that are intended for intravenous, irrigation or ophthalmic use with

exception to eye lubricants

7. Parenteral nutrition solution

8. Peritoneal dialysis solution

9. Blood derivative product

10. Radiopharmaceutical

11. Products with medicinal claims that need high level of evidence including but not limited to [treat,

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

or mind, stress, anxiety and nervous tension (refer to Annex II)]

The following products may be classified as medicine, unless registered as medical device in country of

origin/reference countries (Annex III):

a) In vivo diagnostic agents including imaging agents (e.g. contrast agent).

b) Enema solutions products (rectal solution products).

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

d) An allergen tests are used internally and indicated in the diagnosis of specific allergies.

e) Any product injected into the body (I.V., I.M. or S.C. etc.) either for prevention, diagnostic or

cosmetic purposes e.g. hyaluronic acid, collagen etc.

f) Anti-lice products containing chemical ingredients.

3.1.2. Health product

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

following definition:

Note, the inclusion of medical claims in association with any health product will automatically raise the

classification of the product to a medicine in accordance with Annex II.

3.1.2.1 Herbal product

Herbal products are health products containing as active substances herbal substances or herbal

preparations, alone or in combination as finished, labeled products in pharmaceutical dosage forms

except parenteral forms.

A herbal substance is whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an

unprocessed, usually dried form but sometimes fresh. Certain exudates that have not been subjected to

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a specific treatment are also considered to be herbal substances. Herbal substances are precisely

defined by the plant part used and the botanical name according to the binomial system (genus, species,

variety and author).

A herbal preparation is obtained by subjecting herbal substances to treatments such as extraction,

distillation, expression, purification, concentration or fermentation. These include comminuted or

powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed

exudates.

Herbal products should not carry medicinal indications or make medical claims that are unsuitable for

self-diagnosis and self-treatment i.e. without the intervention of a licensed healthcare professional. Any

claims made in association with herbal products should be consistent with available evidence regarding

the safety and traditional use of those products e.g. European Herbal Substances Community List,

European Herbal Substances Community Monographs, European Scientific Cooperative on Phytotherapy

(ESCOP) Monographs or published peer-reviewed scientific literature and/or other recognized herbal

medicine text books.

In addition products containing any of the ingredients as per Medicines and Healthcare products

Regulatory Agency, UK (MHRA) banned and restricted herbal ingredients list will not be permitted to be

registered as Health Product in Kingdom of Bahrain. For more details refer to the link:

https://www.gov.uk/government/publications/list-of-banned-or-restricted-herbal-ingredients-for-

medicinal-use

3.1.2.2 Combination product (Herbal/Vitamin and Minerals/Others)

Products contain one or more herbal ingredients in addition to one or more vitamins and/or minerals

and/or others that are indicated for adults/children (above 1 year of age)/adolescent.

3.1.2.3 Others

Finished, labeled product in pharmaceutical dosage form (except for parenteral formulation) 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 e.g. Probiotics

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

5. A substance produced by or obtained from bees, including royal jelly, bee pollen and propolis

6. Natural enzyme products

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7. Glucosamine

8. Sulfur in concentration higher than 2%

9. Oral, Nasal or ear Saline solution products e.g. ear drops, nasal spray, nebulizers (unless registered

as medical device in country of origin/reference countries) (Annex III).

10. Crude or refined coal tars

11. Electrolyte products (flavored or not) used as fluid replacement

12. Antiseptic products for human use containing any ingredients of the following* :

Common name

a) Benzalkonium chloride

b) Benzethonium chloride

c) Chlorhexidine gluconate

d) Chloroxylenol

e) Methylbenzethonium chloride

f) Povidone Iodine

g) Hydrogen peroxide

Note:*

Products used for cosmetic purposes and contain one of the above ingredients within the concentrations

recommended by the GSO standards for safety requirements of cosmetic and personal care products will be

classified as cosmetic.

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.

15. Toothpaste/mouthwash products contain one of the following ingredients:

a. Cetylpyridinium

b. Cetrimide

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

All the above are inclusive and not exclusive. For any ingredient not mentioned above, NHRA will be

responsible for its categorization in the Kingdom of Bahrain.

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3.1.3 Alternative and complementary medicine

The diagnostic, therapeutic, preventive and rehabilitative health care systems and practice, with a view

to health maintenance, care and protection through different methods and means and the use of

diverse products; plant, animal, metal or otherwise, which does not fall under modern medicine and

without prejudice to the provisions of Decree Law No. (18) for the year 1997 on regulating the

profession of pharmacy and pharmaceutical centers.

3.2. Products not subject for registration with PPR

Application for classification of these category of product can be received by pharmaceutical product

regulation (PPR) office of NHRA, however PPR shall not be responsible for registration of products falling

in this category.

3.2.1 Food Supplement:

To consider a product as Food Supplement it must meet one or more of the following criteria and/or

type of products:

1. Product containing vitamin/mineral below or equal to the upper intake level (Annex I) will be

considered as food supplement.

2. Any product registered as food supplement (multivitamin and mineral only) in country of origin

(reference competent authority, refer Annex III) will be considered as such in the Kingdom of

Bahrain.

3. Products containing herbs that are not in pharmaceuticals dosage form and have gone through

any manufacturing process such as grinding, extraction, packaging or any other manufacturing

process.

4. Energy drink products should comply with the energy drinks recommendations.

5. Powder/juices etc. products to provide nutritional support to athletes and persons who

regularly practice exercise.

3.2.2 Cosmetic Products

NHRA will considered following as cosmetics

1. Creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc.)

2. Face masks

3. Tinted bases (liquids, pastes, powders)

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

5. Toilet soaps, deodorant soaps, etc

6. Perfumes, toilet waters and eau de cologne

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

8. Depilatories

9. Deodorants and anti- perspirants

10. Alcohol hand sanitizers including (Ethanol 60-80% & Isopropanol 60-70%)

11. Hair care products:

a. Hair tints and bleaches

b. Products for waving, straightening and fixing

c. Setting products

d. Cleansing products (lotions, powders, shampoos)

e. Conditioning products (lotions, creams, oils)

f. Hairdressing products (lotions, lacquers, brilliantine’s)

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

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

14. Products intended for application to lips

15. Products for care of teeth and mouth (devoid of ethyl alcohol and as per GSO standard)

16. Products for nail care and make-up

17. Products for external intimate hygiene which do not contain ingredients that have antimicrobial

activity

18. Sunbathing products

19. Products for tanning without sun

20. Anti-wrinkle products

21. Eye decorative cosmetic products

22. Aromatic and herbal oils that contain one or more of oils that are extracted from plants that

have non nutritional claims and used externally

23. Topical products containing organic acids (Alpha-hydroxy acids (AHAs)) in total concentration of

organic acids up to 10%

24. Insect repellents in direct contact with human skin

All cosmetic products should comply with the following:

1. Free of prohibited substance according to GSO standard in addition to the following substance:

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a) Aspestos.

2. Compatible with restricted substances according to GSO standard in addition to the following

restricted substances (for local use only):

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 medicine).

f. Alpha-hydroxy acids (AHAs) at concentration not more than 10%:

(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)

g. Cosmetic products that come in ampoule and vials should contain the following

instructions in English:

I. For external use only.

II. Avoid contact with eyes

III. Open with Caution

3.2.3 Combined medical device

Combined medical device: is a medical device that is mixed with pharmaceutical or chemical or

biological materials and its principle intended action is physical or mechanical.

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4. Classification query

Where a stakeholder wishes to place a product on the market in the Kingdom of Bahrain but is uncertain

regarding the classification of that product i.e. whether the product is considered to be a

pharmaceutical product or not, he can submit a classification query to NHRA using the Pharmaceutical

product classification application form and check list published at NHRA website: www.nhra.bh

Each application for classification should include all the information requested in the Product

Classification Form & classification checklist, together with the fees per product.

NHRA, reserves the rights to request for more information if required. Classification of the product by

pharmaceutical product regulation office (PPR) does not complete the registration of the product. An

individual application of registration of the product pertaining to its category is required to be submitted

thereafter to relevant section.

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Annex I

Tolerable Upper Intake Level (UL) for Vitamins and Minerals

Life Stage Group Vitamin A (μg AE/day)

Vitamin C (mg/day)

Vitamin D (μg/day)

Vitamin E (mg/day)

Vitamin K1& K2(μg/day)

Children 1-3 Y 600 400 25 179 30

4-8 Y 900 650 25 179 55

Adolescents 9-13 Y 1700 1200 25 179 60

14-18 Y 2800 1800 25 179 75

Adults ≥19 Y 3000 2000 25 179 120

Life Stage Group Thiamine (mg/day)

Riboflavin (mg/day)

Niacin or Niacinamide

(mg/day)

Vitamin B6 (mg/day)

Folate (μg/day)

Children 1-3 Y 100 100 10 30 300

4-8 Y 100 100 15 40 400

Adolescents 9-13 Y 100 100 20 60 600

14-18 Y 100 100 30 80 800

Adults ≥19 Y 100 100 500 100 1000

Life Stage Group Vitamin B12 (μg/day)

Pantothenic acid

(mg/day)

Biotin (μg /day)

Choline (mg/day)

Calcium (mg/day)

Children 1-3 Y 1000 500 500 1000 1500

4-8 Y 1000 500 500 1000 1500

Adolescents 9-13 Y 1000 500 500 1000 1500

14-18 Y 1000 500 500 1000 1500

Adults ≥19 Y 1000 500 500 1000 1500

Life Stage Group Chromium (μg/day)

Fluoride (mg/day)

Iodine (μg/day)

Iron (mg/day)

Magnesium (mg/day)

Children 1-3 Y - 0.7 133 40 65

4-8 Y - 1 200 40 110

Adolescents 9-13 Y - 2 400 40 350

14-18 Y - 3 800 45 350

Adults ≥19 Y 500 4 800 45 500

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Life Stage Group Manganese

(mg /day) Molybdenum

(μg/day) Phosphorus

(mg/day) Selenium (μg/day)

Zinc (mg/day)

Children 1-3 Y 2 300 2000 90 7

4-8 Y 3 600 2000 150 12

Adolescents 9-13 Y 6 1100 2000 280 23

14-18 Y 9 1700 2000 400 34

Adults ≥19 Y 9 2000 2000 400 50

Life Stage Group Potassium (mg/day)

Sodium (g/day)

Chloride (g/day)

Boron (μg/day)

Copper (μg/day)

Children 1-3 Y - 1 1.5 - 700

4-8 Y - 1.2 1.9 - 2500

Adolescents 9-13 Y - 2.3 2.3 - 4000

14-18 Y - 2.3 2.3 - 6500

Adults ≥19 Y 100 2.3 2.3 700 8000

Life Stage Group Nickel (μg /day)

Vanadium (μg/day)

Lutein (mg/day)

Beta-carotene (μg/day)

L-Methionine (mg/day)

Children 1-3 Y - - - 1200 1000

4-8 Y - - - 1800 1000

Adolescents 9-13 Y - - - 3400 1000

14-18 Y - - - 5600 1000

Adults ≥19 Y 350 182 10 6000 1000

Life Stage Group Inositol (mg/day)

Cobalt (μg/day)

Children 1-3 Y 650 44

4-8 Y 650 44

Adolescents 9-13 Y 650 44

14-18 Y 650 44

Adults ≥19 Y 650 44

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Annex II

Examples of words or phrases that in context may suggest or imply a medical claim about a product:

Alleviates … Avoids … Burns fat Can benefit those who suffer from … Combats … Controls … Counteracts … Cures … Eliminates … Fights … Lowers cholesterol Prevents … Removes … Repairs … Restores … Stimulates ... e.g. the nervous system Strips of pre-cancerous sun-damaged cells Treats …

Note: All the above are inclusive and not exclusive

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Annex III

List of reference competent authorities

1. Saudi Food and Drug Administration (SFDA). 2. Gulf Council Corporation – Central Registration (GCC-DR). 3. United States of America Food and Drug Administration (US FDA). 4. Therapeutic Goods Administration Australia (TGA). 5. Health Canada. 6. Ministry of Health, labor and welfare, Japan. 7. Med safe, New Zealand. 8. Swiss medic, Switzerland. 9. European Medicine Agency (EMA). 10. Medicines and Healthcare products Regulatory Agency, UK (MHRA) 11. Federal Institute for Drugs and Medical Devices, Germany (in German: Bundesinstitut für

Arzneimittel und Medizinprodukte - BfArM). 12. National Agency for the Safety of Medicine and Health Products, France (ANSM). 13. Health Products Regulatory Authority, Ireland (HPRA). 14. Medicine Evaluation Board, Netherlands. 15. Medical Product Agency, Sweden. 16. Danish Medicines Agency, Denmark. 17. Federal Agency for Medicine and Health Products, Belgium.

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References

1. Saudi Food and Drug Authority – Product Classification Guidance. 2. Health Canada – Drugs and Health Products Regulations. 3. Irish Medicines Board – Guidelines on herbal medicines.

4. MHRA banned and restricted herbal ingredients list.

5. Dietary Reference Intakes: The Essential Guide to Nutrition Requirements, national Academy of Sciences, USA.

6. Tolerable upper intake levels for vitamins & minerals, European Food Safety Authority, 2006. 7. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper,

Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc, US National

Academy of Sciences, 1997 – 2004. 8. Dietary Reference Intakes for Calcium and Vitamin D, US National Academy of Sciences 2011. 9. GCC Standardization Organization (GSO) 1943/2016. 10. Medicine-combined medical devices guidelines, NHRA. 11. Complementary and alternative medicine resolution (13) of the year 2016, Kingdom of Bahrain. 12. USP Dietary Supplements Compendium.