GCC Regulation for Products Classification

​Products classification is a crucial step in identifying of the subsequent path within regulatory bodies. The Gulf Cooperation Council (GCC) member-states have come up with a realize that more harmonization, overcoming the regulatory differences, and fostering the joint work of product classification, is needed especially for products that are centrally marketed in the gulf region

Therefore, this guideline has been issued to ensure a unified approach; moreover, it has been adopted from the GCC states guidelines of products classification and regulation.

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​This guidance presents the GCC general views as agreed on classification recommendations of specific products or a category of products to assist stakeholders to classify their products, determine the appropriate regulatory scheme, achieve more consistency, and transparency on GCC classification committee activities. However, in areas where a different classification of an individual product exists, among member states, it is important to note that the national regulatory framework must apply, and this guidance shall serve as a tool to support the national classification. Moreover, it is highly important to note that this guidance in not all-inclusive, and it is the responsibility of the applicant to seek a classification advice in case of doubt.

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​As a general consideration, product classification decisions will be depending mainly on the statutory definitions as stated in this document taking into account certain criteria such as the mode(s) of action by which the intended purpose is achieved as well as the way the product is presented, and the product's format. For example, a product may be classified as a medical device if it “does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means. If the product acts by such means, it will be classified as a pharmaceutical drug product.

For borderline cases, the GCC classification committee will classify products on a case-by-case basis considering the complexity of the product, product's full characteristics, and the current scientific and regulatory requirements in alignment with the common international practices in order to reach a consensus on the most appropriate regulatory path.

The following principles are applied when classifying a product:

A) Representation made about the product (therapeutic claims , purpose)

• - Is the product represented in a manner suggesting it is used for treating, diagnosing, preventing, curing diseases, restoring, correcting or modifying organic functions in human beings

• - Is the product likely to be understood by consumers to have characteristics of a drug

• - A claim can be a word, a sentence, a picture, a symbol, a paragraph or an implication on product labels, pack insert, or through advertisements.

• - There are three levels of claims according to WHO:

•            - High level: treats/cures/manages any diseases or disorder prevents any diseases or disorder treats any vitamin/mineral deficiency diseases

•            - Medium level: Health enhancement Reduction of risk or diseases or disorder Assist in management of a named symptom/ diseases or disorder Relief of symptoms of a named diseases or disorder

•           - Low level: Health maintenance, including nutritional supplement Vitamin or mineral supplement Relief of symptoms
  
  B) The composition of the product

• - Does the product's composition suggest it is an agent used for treating, diagnosing, preventing, curing diseases, restoring, correcting or modifying organic functions in human beings?

• - The presence of an ingredient at certain concentration may make the product pharmaceutical or health product.
  
   C)​ Level of action

• - Does the product exert solely a superficial effect?

• - The following definitions are intended only to provide guidance as to the meaning of these terms.

• - Pharmacological mean is defined as an interaction between the molecules of the substance in question and a cellular constituent, usually referred to as a receptor, which either results in a direct response, or blocks the response to another agent. Although not a completely reliable criterion, the presence of a dose-response correlation is indicative of a pharmacological effect.

• - Immunological mean is defined as an action in or on the body by stimulation and/or mobilization of cells and/or products involved in a specific immune reaction.

• - Metabolic mean is defined as an action, which involves an alteration, including stopping, starting or changing the speed of the normal chemical processes participating in, and available for, normal body function.
  
  D) ​Classification scheme of other regulatory authorities

• - Classification in the country of origin

• - Classification in GCC and other Reference countries
  
  

E) Other registered products with the same composition, dosage form & indications.​

This guidance document pertains to a product or category of products that is under the responsibility of the GCC regulations.​

This guideline should be read in conjunction with:

•       - NHRA Pharmaceutical Products Classification Guideline. Kingdom of Bahrain

•       - Saudi Food & Drug Authority Products Classification Guidance. Kingdom of Saudi Arabia

•       - Ministerial Decree for Registration and Release of Health Products & Medical Devices. State of Kuwait

•      - Guidelines for Products Classification. Sultanate of Oman
  

•      - UAE Guidelines for the registration of General Sale Pharmaceutical Products and Related Companies. United Arab Emirates​
  

​Alternative Traditional Medicines:

Any form of Treatment or therapy outside the realm of conventional modern medicine.

Animal Feed:

Any substances, single mixed processed or semi-processed, intended to feed animals, and used as a raw material or as an ingredient in the preparation of manufacturing or processing of feed originating from plant, approved animal source, or aquatic source.

Biological medicinal products:

Medicinal products derived from a variety of natural sources or produced by biotechnology methods and other cutting-edge technologies. They include a wide range of products such as vaccines, blood and blood components, allergenics, advanced therapy medicinal products (ATMPs), recombinant proteins and biosimilars.

Combination Product:

A product consists of two or more items that subject to different jurisdictions in terms of regulatory path, marketing and/or manufacturing. It includes:

A)    Integrated combination product:

•     - A product consists of two or more regulated components that are combined/integrated as a single product.

B)    Non-integrated combination product:

•    -  A product consists of two or more separated items that are contained in the same package. [Co-packaged combination product].

•    -  Any regulated product packaged separately where the labeling information refers to be used with another specific regulated product where both are required to achieve the intended purpose of use. [Cross-labeled combination product].

  
   

Cosmetic Product

Any substance or mixture intended to be placed in contact with the external parts of the 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, protecting them, keeping them in good condition or correcting body odors without having any effect on functions of the body organs or as treatment.

Food

Any substance whether processed, semi-processed or unprocessed, which is intended for direct human consumption or to be used in manufacturing, preparing or treating a foodstuff.

Foods for Special Medical Purposes

Category of foods for uses which are specially processed or formulated and presented for the dietary management of patients and may be used only under medical supervision. They are intended for the exclusive or partial feeding of patients with limited or impaired capacity to take, digest, absorb or metabolize ordinary food stuffs or certain nutrients contained therein , or who have other special medically - determined nutrient requirements, whose dietary uses, or by a combination of the two.

Food Supplement

Products that are used to supplement the normal oral feeding diet, it is intended to boost a specific or several food elements in the diet or for their non-therapeutic nutritional or physiological effects, and it often contains concentrated sources of nutrients or other substances.

Health Product

A Finished labelled product in pharmaceutical dosage forms, that contains low risk ingredients and has indications such as health maintenance, health enhancement and/or modifying physiological functions by exerting pharmacological, immunological or metabolic actions.

Herbal Product

Finished, labeled pharmaceutical dosage form products that contain as active ingredients aerial or underground parts of plants, or other plant material, or combinations of both, that is used to treat or prevent diseases or both.

Homeopathic Drug

Homeopathy is a complementary alternative medical practice based on the use of highly diluted substances, which practitioners claim can cause the body to heal itself. Homeopathic medicines or their stocks/mother tinctures are prepared from natural or synthetic sources that are referenced in pharmacopeial monographs or other recognized documents

Human cells, tissues, or cellular or tissue-bases products (HCT/Ps):

It means articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. Examples of HCT/Ps include, but are not limited to, bone, ligament, skin, dura mater, heart valve, and cornea.

In Vitro Diagnostic (IVD) Medical Device

A medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes.

Medical Device

A)    Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purposes of:

•    - Diagnosis, prevention, monitoring, treatment or alleviation of disease

•    - Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury

•    - Investigation, replacement, modification, or support of the anatomy, or of a physiological process

•    - Supporting or sustaining life

•    - Control of conception

•    - Disinfection of medical devices

•    - Providing information by means of in vitro examination of specimens derived from the human body;
  
  B) Which does not achieve its primary intended action by pharmacological, immunological, or metabolic means, in or on the human body, but which maybe assisted in its intended function by such means.
  
  C)​ Pharmaceutical or Medicinal Drug Product

•    - Any substance or combination of substances that are in a finished pharmaceutical dosage form administered to human beings (used externally or internally) and intended for use in the diagnosis, cure mitigation, treatment, or prevention of disease, OR,Any substance or articles (other than food) intended to affect the structure or any function of the body to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action.

  
   

Public Health Pesticides:

Any chemical substances, inorganic, organic or natural product or biological product containing elements of microorganisms used in the control of pests (including attractive and repellents substances).

Special Food

Foods for special dietary uses: Foods which are specially processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition and/or specific diseases and disorders and which are presented as such. The Composition of these foodstuffs must differ significantly from the composition of ordinary foods of comparable nature.

Tobacco Products:

Any products consisting wholly or partially of tobacco leaves as raw material which has been manufactured for the purpose of direct or non-direct smoking or absorption such as Cigarettes, Almeassel tobacco, Meassel Fruit flavored, cigar, as well as E-Liquids and Heated Tobacco Products which are used by Electronic Nicotine Delivery Systems (ENDS)

Veterinary Drug:

Any substance or mixture of substances manufactures, sold or represented for use in:

• - The diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or its symptoms, in animals.

• - Restoring, correcting or modifying organic function in animals.
  

Part A) of the definition relates to the presentation of the medicinal product and to the claims for it. Section B) of the definition relates to the function and intended use. A pharmaceutical drug product or a medicinal product is any product that falls within either of those 2 definitions. Below the Pharmaceutical drug products will be further elaborated upon in order to facilitate the classification processes and clearly set the criteria of classification. In this paper pharmaceutical and medicinal drug products are used interchangeably.

Composition

The components or ingredients of a finished pharmaceutical product can be a deciding factor in classifying a product as a pharmaceutical drug.

The percentage or amount of pharmacologically active substances can be the deciding factor for classifying pharmaceutical dosage forms as medicinal.

In some cases food supplements or cosmeceuticals in percentages above those accepted and defined (appendix?) mean the effects are more therapeutic and thus must be reclassified as therapeutic supplements or therapeutic cosmeceuticals, respectively.

Active substance - The substance responsible for the activity of a medicine (EMA). Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that becomes the ingredient that elicits the pharmacological, immunological or metabolic action to restore correct or modify physiological functions to make a medical diagnosis.

Strength of a medicinal product- the content of active substance expressed quantitatively per dosage unit of volume or weight according to the dosage form

Dosage form

The finished product pharmaceutical dosage form could be associated with high invasiveness or associated with a delicate extremely fragile bodily component and thus requires to undergo the regulations and scrutiny of a pharmaceutical drug.

For instance, Intravenous drug administration, which bypasses all the bodily defenses and achieves 100% bioavailability making it an extremely dangerous and unpredictable route of administration that could be detrimental to recipients if there was any ease or lag in any part of the product lifecycle (manufacturing, importation, handling & administration). Another example that the above risks apply is the rectal route of administration (enemas and rectal suppositories).

Indications

The claims, statements and phrasing used to describe the effects of the pharmaceutical dosage form outlining what the product is believed to treat, prevent or diagnose can aid in the classification process.

The specific diseases, ailments or deficiencies (or their symptoms) that the product is to be used for clearly stated and meet the definition of pharmaceutical drug product. Almost any ingested or topical or injectable product that, through its label or labeling (including internet websites, promotional pamphlets, and other marketing material), is claimed to be beneficial for therapeutic or diagnostic uses that meet the definition of a drug as outlined in (section 6)  will be regulated as a drug.  The definition also includes components of drugs, such as active pharmaceutical ingredients.

Claims – medicinal claims are claims that a medicine can treat or prevent disease or interfere with the normal operation of a physiological function of the human body.

Some examples of claims include: treat, prevent, soothe, eases, lowers, stops, relieves… etc. A claim is one of the criteria for pharmaceutical classification however designation of a product as a pharmaceutical drug cannot be solely made based on the labelled claim, one of the other criteria has to be met also. On the other hand, claims, such as maintains, improves, and supports health are not considered medicinal and are outlined in (appendix…)

Risk Level

The risk-based approach to classify or regulate pharmaceutical drug products ensures that drugs are used appropriately to protect and advance the public health.  The level of risk associated with a drug product ultimately determines how it can reach the public and who can gain access to said product.

All medicines inherently carry a risk of producing undesired side effects and through review and evaluation the product benefits must prove to outweigh the risks associated.

When evaluating risk, the target population and target organs are assessed.

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Biological products are a diverse category of products and are generally large, complex molecules. These products may be produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell, and are often more difficult to characterize than small molecule drugs. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources - human, animal, or microorganism - and may be produced by biotechnology methods and other cutting-edge technologies.

• A biosimilar is a biological product that is highly similar to an original biological medicine and has no clinically meaningful differences from an existing approved reference product. Every new biosimilar medicine must work the same way as the reference medicine.

Blood Product:

A blood product is any therapeutic substance derived from human blood, including whole blood and other blood components for transfusion, and plasma-derived medicinal products.

Examples: blood components (i.e., red blood cells, platelets and plasma), plasma-derived medicinal products (e.g., albumin, polyvalent and specific immunoglobulins, and blood coagulation factors).

Hormone:
A hormone is a biological compound used by multicellular organisms to organize, coordinate, and control the functions of their cells and tissues. These chemicals can control everything from metabolism to behavior, and are necessary for organisms to survive and reproduce.

Examples: estrogen, testosterone

Monoclonal Antibodies:

Are homogenous products secreted by immortalized B lymphocytes that are cloned and expanded in continuous cell lines. Such cell lines may be cultivated for the stable secretion in large quantities of antibodies of defined specification.

Examples: abciximab, adalimumab. Recombinants protein

Vaccine:

A vaccine is a biological preparation that provides active acquired immunity to a particular infectious disease. A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins. The active ingredient in a vaccine is usually made from the viral or bacterial pathogen itself. There are two different approaches to this, with the pathogen being either alive or inactivated.

Toxin-Antitoxin Antibody:

  Toxin antibody: An antibodies is remarkable in its ability to inactivate even the most potent plant and microbial toxins, including botulinum, tetanus, diphtheria, anthrax and ricin toxins.

  Antitoxin Antibody: An antibody produced in response to and capable of neutralizing a specific biologic toxin such as those that cause diphtheria, gas gangrene, or tetanus. Antitoxins are used prophylactically and therapeutically.

Examples: Botulinum antitoxin, heptavalent (HBAT)

Advanced Therapy Medicinal Products (ATMPs):

These consist of products that contain recombinant nucleic acids or engineered cells and/or tissues. These products are divided into four subcategories:

•    - Gene therapy medicinal products (GTMP):

     These contain genes that lead to a therapeutic, prophylactic or diagnostic effect. They work by inserting 'recombinant' genes into the body, usually to treat a variety of diseases, including genetic disorders, cancer or long-term diseases. A recombinant gene is a stretch of DNA that is created in the laboratory, bringing together DNA from different sources.

•    - Somatic cell therapy medicinal products (SCTMP):

      Contain cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended to be used for the same        essential functions in the body. They can be used to cure, diagnose or prevent diseases.

•    - Tissue-engineered products (hTEP):

     Tissue manipulation products made up of manipulated cells or tissues for regeneration, repair or replacement of human tissue.

•   - Combined ATMPs (cATMPs):

    Consist of one of the first three categories combined with one or more medical devices as an integral part of the product.

   An example of this is cells embedded in a biodegradable matrix or scaffold.

ATMPs might be regulated biological medicines or medical devices. For these products, whatever the role of the medical device, the pharmacological, immunological or metabolcic action of these cells or tissues should be considered to be the principle mood of action of the combination products.

Allergenic Products:

Allergen products of biological origin, including the allergen extracts derived from natural source material such as Pollens, molds and mites mainly consist of proteins and glycoproteins. Also allergens produced through recombinant DNA technology which mainly consist of predefined allergenic polypeptides and used for specific immunotherapy (SIT) or in vivo diagnosis of immunoglobulin E (IgE)-mediated allergic disease.​​

Products containing herbs would be considered as a medicinal herbal product when it falls within the following criteria as stated in the above-mentioned definition; finished labeled product in pharmaceutical dosage forms, and the intended usage of the herbal product in treating, preventing or diagnosing diseases.​

Traditional medicines include a diverse range of health practices, approaches, knowledge and beliefs incorporating medicines of plant, animal and/or mineral origin.

Examples of traditional systems include: Traditional Chinese medicine, Ayurvedic medicine, and Western herbal medicine.

Traditional use is defined as traditional use, for a designated active ingredient, means use of the designated active ingredient that is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and accords with well-established procedures of preparation, application and dosage.
The brand name(s) must not be false or misleading or imply any specific use or purpose.

Examples of conditions for which indications are likely to be permitted in traditional herbal medicines:

Examples of conditions for which indications are unlikely to be permitted in traditional herbal medicines:

•   - Bone diseases

•   - Cardiovascular diseases

•   - Chronic insomnia

•   - Diabetes and other metabolic diseases

•   - Diseases of the liver, biliary system and pancreas

•   - Endocrine diseases

•  -  Genetic disorders

•   - Joint, rheumatic and collagen diseases except for the purpose of the treatment of the symptoms of sprains or strains or the relief of pain or stiffness of rheumatic or non-serious arthritic conditions

•   - Malignant diseases

•   - Psychiatric diseases

•   - Serious disorders of the eye and ear

•   - Serious gastrointestinal diseases

•   - Serious infectious diseases including HIV-related diseases and tuberculosis

•   - Serious neurological and muscular diseases. except for the purpose of prevention of neural tube defects.

•   - Serious renal diseases

•   - Serious respiratory diseases

•   - Serious skin disorders

•   - Sexually transmitted disease
  

For banned and restricted herbal ingredients, refer to GCC references list.
The route(s) of administration must be consistent with the routes of administration specified by referenced texts/pharmacopeias.

​Sterile preparations are not permitted in traditional medicines.

The quantity(ies) must be within the daily dosage range specified by referenced texts/ pharmacopeias considering additive effects between ingredients of similar actions or properties.

A)     AYURVEDIC MEDICINES

Classical or Traditional or generic formulation  

Ayurveda is having two types of formulations one is Classical or traditional or generic and patent formulations

1. Classical formulations
   
   The formulations which has been mentioned in Ayurveda classical text books like Charaka samhita, Sushruta samhita etc. the manufacturing companies follow the same formula and prepares the medicines, for example- Kashaya, Churna etc.
2. Proprietary or Patent   formulations

This are also known as modern Ayurveda Medicines, their formula, dosage form are decided by the manufacturing companies and selection of the herbs also will be decided by the pharmaceutical companies, whereas the herbs should have classical reference in the Ayurveda texts for their properties.

Patent formulations are of four types

1.   Madicinal formulations in Ayurveda are divided into 2 sub parts (A) Textual rationale, (B) Experiential and R&D based

A. Textual rationale:

The patent medicines which has to be formulated from the pharmaceutical company, the ingredients used in the formulation should have textual reference (classical reference in the Ayurveda text book) regarding the dosage form and indication

(For example- liver tone is a patent medicines where it is used for liver condition, and the main ingredient of this medicine is Turmeric, then the turmeric should have the property as liver tonic in classical Ayurveda text book)

B.  Experimental and R&D

 Based means, if the ingredients which are used in any patent formulation does not have any classical reference then that drug should undergo experimental study and R&D study.

(For example- Bocopa Monerri is having Brain tonic property, but when you want to use Bacopa monneri as Anti-inflammatory property where it has not any any reference then you should go for further experimental and R&D studies.)

2.   Nutritive medicinal formulations

Medicinal plants which are used with the intention of health maintenance, to be administered for specific conditions.

3.   Cosmeceutical medicinal formulations

Cosmeceutical medicinal formulations are cosmetic products intended to improve physical appearance, health, and beauty and skin ailments. Drugs used to control acne, anti-wrinkle effects, protect from sun burn, improves complexion, delayed effect of ageing and improve skin textures, etc. are comes under category of Cosmeceutical  medicinal formulations. Cosmeceuticals may be synthetic, natural or hybrid depending upon their compositions.

4.   Extract-based formulations (Aqueous, hydro-alcoholic and other extracts)

Herbal medicine products include herbs, herbal materials, herbal preparations, and finished herbal products that contain parts of plants, other plant materials, or combinations thereof as active ingredients. Herbs include crude plant material, for example, leaves, flowers, fruit, seed, and stems. Herbal materials include, in addition to herbs, fresh juices, gums, fixed oils, essential oils, resins, and dry powders of herbs.

Herbal preparations are the basis for finished herbal products and may include comminuted or powdered herbal materials, or extracts, tinctures, and fatty oils of herbal materials. Finished herbal products consist of herbal preparations made from one or more herbs.

There are several methods or operation involved in obtaining the herbal extract/phytopharmaceuticals/ bioactive phytoconstituents and these depend to some extent on the particular part of the plant which is being used. The main objective of each process is to obtain the extract in a pure state and free from any contaminating materials which may affect the odor, the physicochemical or pharmacological properties of the final formulation.

Phyto-pharmaceuticals (are not ASU&H drugs)

According to the new guidelines Phyto-pharmaceuticals that is the herbal plants which undergoes the process of extracts like Aqueous and Alcohol will be not considered as Ayurveda Medicines.

The reason is, the herbal medicines which undergoes the process of extraction the natural property of the medicine will change as it will added with Alcohol and others extract base, that the reason why it will not be considered as Ayurveda medicines.

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Classical/Traditional Dosage Forms:

•   - Wholesome Juice

•   - Dry powder

•   - Decoction

•   - Hot and cold infusion

•   - Paste jam like preparation

•   - Fermentation liquid with self-generated alcohol

•   - Medicated oil/ghrit

•   - Pills

•   - Incinerated powder.

Proprietary dosage forms

Any contemporary dosage form except injection or parenteral use form of drug.

B)    TRADITIONAL CHINESE MEDICINE (TCM)

According to WHO, (TCM) has been in use in China for over two thousand years. It has its own unique theories for treating disease and to enhance health. There are many modalities included in TCM, such as Chinese herbal medicine, moxibustion, acupuncture, or Tuina.

These medicines include herbs, herbal materials, herbal preparations and finished herbal products which have been documented in classical and modern literature on TCM.

These may contain non-plant substances, such as animal and mineral materials.

Routs of Administration:

•    - Oral route of administration for tinctures, dried plant material, decoctions, expressed juices, etc.

•    - Buccal route of administration for rinse or gargle preparations.

•    - Topical route of administration for creams, ointments, essential oils, expressed juices, etc.

  
  

Dosage Forms:

•    - Products that are tinctures can be supported by referenced texts that provide information on fluidextracts (ethanolic); spirit-based preparations (e.g.: plant material mixed with wine; plant material mixed with whisky); ethanolic tinctures (with known extract ratio); dried powdered extracts (with known Quantity crude equivalent (QCE)).

•    - Products that are ointments, liniments, creams, etc. can be supported by referenced texts that provide information on dried plant material or powdered extracts (with known QCE).

•    - Buccal gargle or rinse preparations can be supported by referenced texts that provide information on dried plant material, powdered extracts, and ethanolic-based preparations (with known QCE).
  

• Essential oils and resins can be supported by referenced texts that provide information on the specific essential oils or resins (drops).

  
  

Groups⁽⁶⁾:

• Adults (≥ 18 years)

  
  

Ingredients:

•    - A monograph from one of the accepted pharmacopoeias must be referenced for each medicinal ingredient.

The Pharmacopoeia of the People's Republic of China (PPRC)

•    - Approval letter from pharmacopeia for the submitted combination / formula.
  

C)     HOMEOPATHIC MEDICINES

Homeopathic medicines⁽¹⁾ are formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate, a principle known as “like-cures-like"; and prepared according to the practices of homoeopathic pharmacy using the methods of:

• serial dilution and succussion of a mother tincture in water, ethanol, aqueous ethanol or glycerol; or

• serial trituration in lactose

The more diluted the substance, the more potent it is, which is known as the “law of infinitesimals."

Routs of Administration:

Routs of administration include, but are not limited to: oral, sublingual, nasal and topical.

Dosage Forms:

• - Acceptable dosage forms for homeopathic medicines are those outlined in the accepted homeopathic pharmacopoeia.

• - Dosage forms include, but are not limited to:

•   - powder; granule;

•    - pellet/globule/pilule; tablet;

•    - solution;

•    - ointment/cream/lotion/gel;

•    - syrup;

Ingredients:

A monograph from one of the accepted homeopathic pharmacopoeias must be referenced for each medicinal ingredient.

•   - Homeopathic Pharmacopeia of the United States (HPUS)

•   - Homöopathisches ArzneiBuch (HAB) or German Homeopathic Pharmacopoeia (GHP)

•   - Pharmacopée française or French Pharmacopoeia (PhF)

•   - European Pharmacopoeia (Ph.Eur.)

•   - Encyclopedia of Homeopathic Pharmacopoeia (EHP)

Homeopathic medicines are made from a wide range of natural or synthetic sources, may consist of the following:

•    - plant material such as: roots, stems, leaves, flowers, bark, pollen, lichen, moss, ferns and algae;

•    - microorganisms such as: fungi, bacteria, viruses and plant parasites;

•    - animal materials such as: whole animals, animal organs, tissues, secretions, cell lines, toxins, nosodes, blood products;

•    - human materials such as: tissues, secretions, cell lines and endogenous molecules such as hormones;

•    - minerals and chemicals.​​
  

​When a substance, part of a substance or a combination of substances associated with a therapeutic (medicinal) property or pharmacological effect.

Insecticides:

Veterinary products, which contain substances that kill insects or external parasites, such as pyrethrins, pyrethroids or organophosphate compounds.

Shampoos:

A shampoo for animals will be considered medicinal if it contains an insecticide or an ingredient, which has a pharmacological effect or is presented as an insecticidal shampoo.

Teat and Udder Products:

Products applied internally to teats and udders for the prevention of mastitis.

Herbal Products:

Herbal products require a market authorization if they are medicinal by presentation or function. For example, a product containing pyrethrum, pyrethrins or alkaloids, such as digoxin from Digitalis sp., would be considered medicinal by function.

Diagnostic Tools (Testing Kits):

Any substance or combination of substances administered to animals with a view to making a medical diagnosis.​

A product would be considered as health product for registration if it meets the following criteria as stated in the above-definition; finished labeled product in pharmaceutical dosage forms, which may contain one or more of the following ingredients (the list in non-exclusive),

• ​- Amino acid
  

• - Charcoal

• - Tar

• - One or more vitamins and/or minerals with concentrations equal or below the upper concentration limit provided that none 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.

• - Medicated throat lozenges or lozenges consists of volatile oils with no unacceptable claim

• - Natural enzyme products

• - Probiotics and prebiotics that are marketed in pharmaceutical dosage form

• - 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 structure

• - Electrolyte products other than those used as fluid replacement for athletes

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

- Topical products containing organic acids (Alpha-hydroxy acids (AHAs)) in total concentration of organic acids more than the recommended by the GSO standards for cosmetic products​​

Cosmetic product intended for use internally cannot be considered cosmetic product, such as:

• - Products taken orally (syrup, solution, drink, capsules, tablet…etc)

• - Products that are taken through the eyes or nose or ear (drops, sprayer...etc)

• - Products intended for injection (IV, IM, IS…etc)

• - Products that are taken through the anal or vagina (Enema, suppository, solution, tab, capsules… etc)

A.    Cosmetic products should not contain medicinal or therapeutic claims, and they should not have a significant physiological effect. However, cosmetics should be used exclusively or mainly, on the sites of application stated on the definition, to clean, perfume, change the appearance and/or correcting body odors and/or protecting or keeping them in good condition.

B.     Cosmetic products should not contain any medicinal or therapeutic substances.

C.    Some products categories could be considered as cosmetics such as the followings:

•   - Skin care products such as: facemask, eye contour products, lip care products, hand care products, chemical exfoliation products, skin lightening products

•   - Skin cleansing products: soap, bath/shower products, make-up remover products, External Intimate hygiene products, other skin cleansing products.

•   - Body hair removal product

•   - Chemical depilatories, Physical epilation products, other body hair removal products

•   - Body hair bleaching product

•   - Correction of body odor, perspiration, and/or deodorants

•   - Products with antiperspirant activity, Products without antiperspirant activity.

•   - Perfumes

•   - Shaving products 

•   - Make-up products such as foundation, eyeliner, body face paint…etc.

•   - Sun and self-tanning products

•   - Hair and scalp care and cleansing products such as shampoo, antidandruff, anti-hair loss, conditioner…etc.

•   - Hair coloring products Oxidative hair colour products , Non- oxidative hair color    products , Hair bleaching and dye remover products , other hair colouring products.    

•   - Hair styling products

•   - Products for temporary hair styling , Permanent wave products, Hair relaxer / Straightener products, other hair styling products.

•   - Other hair and scalp products.

•   - Hair sun protection products , other hair and scalp products
  

•   - Nail and cuticle products such as nail varnish, nail make-up, nail glue remover products, nail sculpting products…etc.

  
  

D.     Oral hygiene products

•   - Toothcare products, Toothpaste, Tooth cleansing powder / salt, other tooth care products, Toothpaste products contain one of the following ingredients in a concentration as  Recommended by the GSO standards for cosmetic products:

•        - Triclosan

•       - Chlorhexidine

•       - Cetylpyridinium

•       - Cetrimide
  
   

•  - Mouth wash / breathe spray:

•         - Mouth wash , Breath spray , other mouthwash / breath spray products

•        -  Tooth whiteners

       - Other oral hygiene products

The product must meet the conditions stipulated in point A and B of the medical device definition to be considered as medical device. Moreover, medical devices are classified based on the level of risk to patients, users and other persons. The manufacturer is responsible for determining the classification of a device using a set of classification rules based on factors such as:

•   - Manufacturer's intended use of the device, which can be obtained from: Instructions for Use (IFU), label, manufacturer's advertising materials, technical documentation

•   - Degree and site of invasiveness in the human body

•   - Duration of use

•   - Combination with another device and accessories

•   - The activity of the device and whether the device deliver medicines or energy to the patient

The following list includes the main categories of medical devices with illustrative examples, however the list it is not exclusive:

A.    In-Vitro Diagnostic Medical Devices (IVDs)

•   - Reagents used for clinical diagnostic

•   - The calibrators and control materials used to verify the performance of the analyzers

•   - Kits that contain IVDs such as Blood glucose meters and strips

•   - Pregnancy test and ovulation test kit

B.     Topical products

•   - Silicon based products for scar management (sheets, gels, sprays...etc.)

•   - Non-medicated dressing used as a physical barrier, for compression or for absorption of exudates such as hydrogel dressings and Alginate dressing

•   - Devices principally intended to manage the micro-environment of a wound such as honey wound dressing gel

•   - Wound dressing with antimicrobial substance such as silver to protect the dressing and reduce odor

•   - Anti-lice Products which act by non-pharmacological, non-immunological, non-metabolic means

•   - Heat/cold pads for pain relief

•   - Wound irrigation solution (water/ saline based)

C.    General hygiene products

•   - Sanitary pads claiming pain relief by physical means

•   - Nipple shields to protect or relieve sore, damaged or cracked nipples or to be which is used to cover and protect the nipple of a nursing mother

•   - Surgical Razors and clippers for specific medical purpose

D.    Dental Devices

•   - Dental filling materials, fissures, sealants, crowns and bridges

•   - Dental impression materials and (mixer/syringe /trays).

•   - Dental alloys, root canal preparations, etc.

•   - Orthodontic materials, removable dental prosthesis

•   - Dental units

•   - Pulp tester

E.     Ophthalmic products

•   - Eye drops intended for the alleviation dryness or discomfort caused by environmental factors

•   - Spectacle lenses used to protect the eyes from light

•   - Contact lenses for therapeutic use

•   - Products used for disinfecting, cleaning, rinsing or, hydrating contact lenses

•   - Sunglasses and spectacle frames

•   - Ophthalmic irrigation solutions principally intended for irrigation as balanced salt solution

•   - Ophthalmic viscoelastic devices

F.     Nasal and ear preparations

•   - Nasal normal saline products such as spray, drops

•   - Ear wax removal products that acts by physical or mechanical meaning

G.    Lubricants, moisturizing and gels

•   - Artificial saliva

•   - Non-medicated sexual lubricants during sexual intercourse

•   - Body orifice gel intended to facilitate entry of a device into a body orifice in the body

•   - Coupling gel applied between an analytical device and the patient, allowing signals to pass through the skin during an examination
  

H.    Devices for blood and organ products

•   - Hemodialysis solution

•   - Organ preservation, transport, nutrition solution

•   - Blood bags (including those containing or coated with an anticoagulant)

•   - Devices intended for temporary storage and transport of organs for transplantation (i.e., containers, bags and similar products)

•   - Devices intended for long term storage of biological substances and tissues such as corneas, sperm, human embryos, etc. (i.e., containers, bags and similar products)

•   - Fridges specifically intended for storing blood, tissues etc

I.       Contraception devices

•   - Intrauterine contraceptive device

•   - Latex condoms without local anesthetic & spermicide

•   - Contraceptive diaphragms

•   - Female condoms

J.      Devices/products for Personal protection

Surgical and examination gloves

•   - Medical facemasks

•   - Surgical apparel which includes surgical caps, hoods, masks, gowns, drapes, operating room shoes and shoe covers, and isolation masks and gowns

•   - Surgical non-medicated sponges

K.    In Vitro Fertilization (IVF) and Assisted Reproduction Technologies (ART) products

•   - Devices manufactured utilizing animal tissues or derivatives rendered non- viable

•   - Devices incorporating, as an integral part, a human blood derivative or a medicinal product is liable to act on the human body with action ancillary to that of the devices

•   - Media intended for use in the IVF process to support the growth storage of the embryo

L.     Radiation Emitting Device/products

•   - Imaging Products (X-ray, CT, MRI, US, and Nuclear imaging products)

•   - Diagnostic Radioactive materials

•   - Digital imaging/x-ray film cassette

M.   Assistive/supportive products

•   - Wheelchairs

•   - Patient's beds

•   - Hearing aids

•   - Walking crutches

•   - Patient hoists

N.    Sterilization and disinfection:

Any article intended to be used for disinfection of medical devices is considered to be a medical device because it is explicitly stated in the definition of medical device and, therefore, is a standalone medical device. However, a disinfectant that is specifically intended for the disinfection of a specific medical device is considered an accessory to this device.
Example of medical devices:

•   - Ethylene oxide sterilizer

•   - Detergents for sterilization of medical devices

•   - Disinfectants for dental water line and the fluid pathways of haemodialysis machine

•   - Denture disinfecting products

•   - Medical Washers

•   - A pre-sterilization device to clean instruments before being sterilized is considered a medical device. For example, Ultrasonic cleaning unit.

O.    Devices without an intended medical purpose

•   - Contact lenses or other items intended to be introduced into or onto the eye.

     For Example: Non-prescription colored contact lenses

•   - Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.

    For Example: Solid body contour modifying implant (e.g. Clavicle or collarbone piercing.

• Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing .

For Example: Dermal fillers

•   - Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.

    For Example: Body sculpting equipment

• -  High intensity electromagnetic radiation (e.g., infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.

    For Example: Intense pulsed light (IPL) machines for body hair removal

• -  Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.

    For Example: Transcranial (no surgically invasive) stimulation

  - The product considered as a food when it falls under the following categories:

•   - Meat and meat products.

•   - Fish and Shell-Fish Products.

•   - Milk and dairy products.

•   - Processed fruits and vegetables products.

•   - Cereals, Pulses and Nuts and Their Products.

•   - Vegetable fats, Oils and Their Products.

•   - Water and Beverages, which do not contain ingredients with medicinal effect.

•   - Electrolyte products (Oral Rehydration Solution), which do not contain ingredients with medicinal effect and unacceptable claim.

•   - Honey and foods that contain bee products such as royal jelly, bee pollen and propolis with exception of products marketed in pharmaceutical dosage forms

•   - Energy drinks.

•   - Food additives that are intended for food industrial uses.

•   - Food sweeteners.

•   - Infant and baby foods, such as Cereal-based food, Rusks, High protein food and others.

•   - Foods for special medical purposes, such as Nutritionally complete formula, Nutritionally incomplete formula, Formulas for metabolic "genetic" disorders in patients over 12 months, and Oral Rehydration Solutions

•   - Proteins, Carbohydrates and Amino acids products that are used as food supplement, with exception of amino acids and protein products in pharmaceutical form.

•   - Vitamins and minerals supplements with exception of supplements marketed in pharmaceutical forms and with concentrations equal or below the upper concentration limit. The upper and lower concentrations limits will be calculated according to the product total daily dose.

•   - Lozenges, which do not contain unacceptable claim or any ingredient with medicinal effect, and the concentration individual ingredients must not exceed the maximum value permitted as follows:

•     - Menthol must not exceed the maximum value permitted of 5 mg as single serving size, and to a maximum daily serving of 50 mg

•     - Eucalyptus oil of 0.5 mg as single serving size.
  

• 
  

•   - Collagen products that may contain vitamins and minerals, and must not exceed the maximum daily serving of 10 mg with exception of products marketed in pharmaceutical forms.

•   - Food products that contain Moringa leaves with exception of products marketed in pharmaceutical forms.

•   - Novel foods, which do not contain ingredients with medicinal effect.

•   - Prebiotic and Probiotic for industrial use.

•   - Food products, which contain fish oil with exception of products marketed in pharmaceutical dosage forms.

•   - Fibers products with exception of products marketed in pharmaceutical dosage forms.

•   - Sports food such as sports drinks, products in powder forms that are intended for sports people and persons who exercise to achieve specific nutritional or functional support, with exception of supplements marketed in pharmaceutical dosage forms.

•   - Weight management products which do not contain unacceptable claim with exception of products marketed in pharmaceutical dosage forms.

​It includes the following product types:

• - Cigarettes

• - Cigars and Tuscan cigars

• - Sijaritus

• - Almeassel tobacco

• - Hand-rolling tobacco and A mixture of tobacco pipe

• - E-Liquids and Heated Tobacco Products which are used by Electronic Nicotin Delivery Systems (ENDS)

• - Non-nicotine e-liquids which are used by electronic smoking device, and does not contain any medical ingredients or medical claims
  

• - Non-smoked tobacco such as (Timpak, shamma, swika etc.) is prohibited.
  

​

Animal Feed includes the following types:

A.    Feed materials

Is a product of vegetable or animal origin, the main purpose of which is to meet the nutritional needs of animals and which is used for oral feeding, in their natural state, fresh or preserved. Such as:

•    - Cereal grains and their derivatives,

•    - Forages and roughage

•    - Oil seeds, oil fruits and their derivatives,

•    - Other seeds and fruits and their derivatives

•    - Legume seeds and their derivatives,

•    - Tubers, roots

•    - Milk and milk-based products,

•    - Fish, other marine animals and their products,

•    - Minerals,

•    - Land animal products and their derivatives

   

B.     Feed additives

Are substances, micro-organisms or preparations that are intentionally added to feed for technological purposes, to improve its taste, to increase its nutritional value, or to improve the animal's performance, whether these ingredients contain nutritional value or not.

C.    Premixture:

Are Mixtures of feed additives or mixtures of one or more feed additives with feed materials or water used as carriers, and is intended for incorporation in compound feedingstuffs, feed materials or water and not meant for direct feeding to animals.

D.    Compound feed:

A mixture of at least two feed materials, whether or not containing feed additives.

-        Public Health Pesticides

Borderline products are products which are difficult to determine whether they are considered as drugs, medical device, food, cosmetics or health products.

And as mentioned in the general principles above, borderline products are classified on case-by-case bases taking into account the following criteria:

•   - Product ingredients and format

•   - The claim about the product

•   - Public perception and history of use

•   - Products representation to the consumers

•   - The mode of action     

•   - Classification decisions of in a stringent regulatory authority

      There are different categories of borderline products, and it may fall generally into the following:

•   - Pharmaceutical medicinal products borderline

•   - Cosmetics borderline

•   - Food and food supplements borderline

•   - Medical device borderline

•   - Health products borderline

•   - Herbal products borderline

  For examples:

A. Drug-Food Borderline Product:

The statutory definition A of pharmaceutical drug product, relates to the pharmaceutical dosage form, and the intended use of treating, preventing diseases and/or affecting the structure or function of the body. While definition B, relates to the function and intended use. A pharmaceutical drug product is any product that falls within either of those two definitions

The food product, as per the definition, depends mainly on the primary claim, products consumed generally for their nutritional value, hydration, taste, flavor, or as part of diet...etc., are considered as food, unless they contain a medicinal substance. Moreover, products primarily used in manufacturing, preparing, or treating food are regarded as food.

The GCC Classification Committee considers the following factors to determine if the product satisfies the above condition:

The intended use (claim) made on the labeling, websites, promotional/advertisement materials, etc.

•   - Any claim (implicit or explicit) or reference to a medical condition, symptoms, alleviation and/or prevention of a disease...etc., of a disease is considered as medical claim. Thus, products with these claims will be classified under drug regulation, as they satisfy the first condition of the pharmaceutical drug definition.

•   - However, certain health claims to “maintain or help support health...etc." are acceptable under food regulation, and these claims should comply with the GSO Requirement for Health and Nutrition Claims.

The compositions of the product, and the way they affect the body

•   - The GCC Classification Committee will review all available evidence related to the compositions, and the mode of action where such ingredients affect the body to achieve the intended use. For example, there are certain active ingredients that are approved by the GCC member states to be drug substances, while others have a well-established and published scientific evidence to demonstrate a pharmacological, immunological, or metabolic action at certain level or concentration which will subject the product under drug regulation.

The product format:

•   - There are some forms that are considered typically to be pharmaceutical forms, such as injections, suspensions, capsules, tablets, inhalers...etc., while on the other hands, some forms are considered borderline especially liquids and powders. However, in order to support the determination of the dosage form as “pharmaceutical dosage form", there are some factors that could help, e.g., the presence of a measuring tool, or in case that the product is packaged and labeled with dosing instructions that allow it to be consumed in controlled doses...etc.

•   - Food product or dietary supplements such as minerals or vitamins that are presented in pharmaceutical dosage form will be regarded as pharmaceutical drug product as they satisfy the first arm (definition A) of the drug statutory definition.

B.  Borderline between cosmetics and other legislations:

The statutory definition of cosmetic is based on two cumulative conditions (the first condition, is the site of application, and the second is the primary intended purpose). A product needs to fulfil both conditions to be regarded as cosmetic. Moreover, cosmetic products must comply with all safety, technical and any product's specific standards (if available)

The GCC Classification Committee considers the following factors to determine if the product satisfies the above conditions:

The intended use (claim) made on the labeling, websites, promotional/advertisement materials, etc.

•   - The proposed claim(s) for cosmetic product must be in relation to the cosmetic function i.e. “cleaning the external parts of the body, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors."

•   - There are some ingredients known to have both medicinal and cosmetic uses, for these ingredients to be regarded under cosmetic legislation, a product must not presented (implicitly or explicitly) to treat, diagnose, and/or prevent a disease.

•   - For products having a secondary health claim to the primary cosmetic purpose, they will be classified as cosmetic product. For example, a cosmetic product containing an ingredient functioning as a preservative or a broad (non-specific) antimicrobial secondary to the main cosmetic purpose.
  

The compositions of the product, and the way they affect the body

•   - Some products have the ability to affect the physiological function of the body, for example, skin care products that may affect the physiological function of the skin cell, keeping them in a good condition and to some extent, changing the skin appearance. This insignificant physiological mode of action does not usually exclude the product from cosmetic legislation.

The product format:

•   - As per the statutory definition of cosmetic, products intended to be placed in contact with nasal mucosa, eye, ear, as well as products ingested, injected or used for rectal or internal genital organs are not cosmetic products.

•   - Products used for oral hygiene care especially those presented in forms need to be swallowed to achieve their cosmetic purpose, they will not be considered as cosmetics if the swallowing is ancillary, for example, breath-mint or deodorizing lozenges. However, if the swallowing is incidental to the cosmetic purpose, (for example, breath spray and/or mouthwash), then the product will be regarded as cosmetic.

C. Borderline between medical device and other legislations

Based on medical devices statutory definition mentioned in this document, a product will be regulated under medical device sector if it meets the two cumulative conditions stated below:

•   - The claim or the primary intended purpose

•   - The mode of action (non-pharmacological, non-immunological, non-metabolic) by which the product achieves its claim

The GCC Classification Committee considers the following factors to determine if the product satisfies the above conditions:

The intended use (claim) made on the labeling, websites, promotional/advertisement materials, etc.

•   - In general, a product with medical claims such as to treat, diagnose, and/or prevent a disease is either drug or medical device. For medical device, the product must not achieve its intended purpose by pharmacological, immunological or metabolic means.

•   - There are certain products might be presented with cosmetic claims such as skin pealing, skin caring, or tooth whitening, these products could fall under the medical device regulation depending on the product's full characteristics and the primary mode of action.

The compositions of the product, and the way they affect the body

•   - Some medical devices may contain a drug or a herbal substance that acts on human body by ancillary mode of action; such products will not be excluded from medical device regulation. For example, anti-lice products containing natural source oils that act by electro-acting or suffocating the lice or its egg.

•   - Certain products that are without an intended medical purpose could be registered as medical devices based on primary the mode of action as well as the classification rules for medical devices. However, it is highly important to determine the most appropriate regulatory path on case-by-case basis, taking into account, the full product's characteristics and classification criteria.

The product formats

For products presented in pharmaceutical dosage forms, these products will not be regarded as medical devices unless they satisfy both conditions of the medical device's statutory definition. For examples, products presented to be ingested I capsule or tablet forms, for treating obesity, and which act by physical means such as bulking agents

Combination products are products that consist of two or more items subject to different jurisdictions, and they may fall into the following categories:

A.    Integrated combination product:

A product consists of two or more regulated components that are combined/integrated as a single product.

For examples:

•   - Prefilled drug delivery systems (syringes, insulin injector pen, metered dose inhaler)

•   - Device coated or impregnated with a drug or biologic (transdermal patch, drug eluting stent)

B.     Non-integrated combination product:

A product consists of two or more separated items that are contained in the same package. [Co-packaged combination product].

For examples:

•   - First aid kits containing devices (bandages, gauze), and drugs (antibiotic ointments, pain relievers)

•   - Drug or vaccine vial packaged with a delivery device

Any regulated product packaged separately where the labeling information refers to be used with another specific regulated product where both are required to achieve the intended purpose of use. [Cross-labeled combination product].

For examples:

•   - Light-emitting device and a light-activated drug

•   - Drug/biological product utilizes a device where it is required that the two should be cross-labeled.
  
  In order to classify the combination and designate the leading regulatory agency for premarket review, the following points will be considered:

•     - The intended purpose of the product taking into account the way the product is presented

•     - The primary mode of action by which the intended purpose is achieved.

 Products that achieve their primary intended purpose by pharmacological, immunological or metabolic action in/on the body; shall be regulated as pharmaceutical drug product.

Products that do not achieve their principal intended action in or on the body by pharmacological, immunological or metabolic means, but that may be assisted in its intended function by such means, shall be regulated as medical device.

Examples of combination products with the leading agency: