1 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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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
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
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.
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.