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Drugs and Health Products

Annexes - Quality Assurance Person Qualification Form

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Annex 1 - List of dosage forms

Dosage form. The final physical form of the natural health product that may be used by the consumer without requiring any further manufacturing.

Note: Applicants are not limited to using dosage forms on this list.
Dosage Form Definition Synonyms Route of Administration

Aerosol

A pressurized pharmaceutical form that contains medicinal agents released upon activation of an appropriate valve system.

Aerosol (without propellant)

Inhalation, topical, nasal

Aerosol, metered dose

A pressurized pharmaceutical form that contains medicinal agents and consists of a metered dose valve that allows for the delivery of a uniform quantity of spray upon each activation.

 

Inhalation, topical, nasal

Bar, chewable

A solid pharmaceutical form that contains medicinal agents usually in the form of a rectangle. It is meant to be chewed.

 

Oral

Bulk/loose

Any plant material to be used as a final dosage form.

 

Oral, buccal, topical, rectal, sublingual, transdermal, vaginal, otic, nasal, ophthalmic

Capsule

A solid pharmaceutical form that contains medicinal agents within either a hard or soft soluble container or shell. The shells are made of gelatin or other substance.

 

Oral

Capsule, combined release

A capsule that consists of two or more medicinal agents with different delivery characteristics (e.g. immediate release and extended release).

Capsule, dual release

Oral

Capsule, delayed release

A capsule formulated to release the medicinal agents at any time other than promptly after administration.

Enteric coated, repeat action

Oral

Capsule, extended release

A capsule formulated to release the medicinal agents in such a manner to allow a reduction in dosing frequency as compared to that of the medicinal agents presented as a conventional dosage form.

Sustained release, prolonged release, controlled release, timed release

Oral

Cream

A semi-solid pharmaceutical form that contains medicinal agents dissolved or dispersed in either an oil-in-water emulsion or in another type of water-washable base.

 

Topical, transdermal

Cream, liposomal

A semi-solid pharmaceutical form that contains medicinal agents and consists of solid particles dispersed in either an oil-in-water emulsion or in another type of water-washable base.

 

Topical, transdermal

Dentifrice, gel

A gel formulation that contains medicinal agents intended to clean and polish the teeth.

Toothpaste

Dental

Dentifrice, paste

A paste formulation that contains medicinal agents intended to clean and polish the teeth.

Toothpaste

Dental

Douche

A liquid pharmaceutical form containing medicinal agents dissolved in a suitable solvent or mutually miscible solvents that is prepared from powders, liquid solutions or liquid concentrates. It is intended for the irrigative cleansing of the vagina.

 

Vaginal

Dressing

An external application that contains medicinal agents, resembles an ointment, and is usually used as a covering or protection.

 

Topical, rectal, vaginal, ophthalmic, otic

Elixir

A clear, pleasantly flavoured and sweetened hydro-alcoholic liquid that contains dissolved medicinal agents. It is intended for oral use.

 

Oral

Emulsion

A two-phase system that contains medicinal agents, in which one liquid is dispersed through another liquid in the form of small droplets.

 

Topical

Enema

A solution introduced into the rectum to promote evacuation of feces or as a means of administering medicinal substances.

 

Rectal

Floss

A thread (waxed or unwaxed) that contains medicinal agents and is used for cleaning between the teeth.

 

Dental

Fluid extract

An alcoholic or hydro-alcoholic preparation generally providing a dry or fresh herb strength ratio of 1:1 or 1:2.

Liquid extract

Oral

Gel

A semi-solid pharmaceutical form that contains medicinal agents and consists of liquids gelled by means of suitable gelling agents.

Jelly

Topical, oral, vaginal, rectal

Gel, extended release

A gel formulated to release the medicinal agents in such a manner to allow a reduction in dosing frequency as compared to that of the medicinal agents presented as a conventional dosage form.

Sustained release, prolonged release, controlled release, timed release

Topical, oral, vaginal, rectal

Globules

A small globular mass made of pure sucrose, lactose or other appropriate polysaccharides that are medicated through a drug attenuation process.

Pellets, pillules

For homeopathic products only

Granule

A small particle or grain that contains medicinal agents. They are intended for oral administration. Some are swallowed as such, some are chewed and some are dissolved or dispersed in water or another liquid before being administered.

 

Oral

Granule, effervescent

A granule in a dry mixture usually composed of sodium bicarbonate, citric acid and tartaric acid that, when in contact with water, has the capability to release gas, resulting in effervescence.

 

Oral

Granule, delayed release

A granule formulated to release the medicinal agents at any time other than promptly after administration.

Enteric coated

Oral

Gum, chewing

A solid, single-dose preparation that contains medicinal agents, with a base consisting mainly of gum. It is intended to be chewed but not swallowed.

 

Oral

Jam

A sweet, thick mixture of fruit and sugar that contains medicinal agents.

 

Oral

Kit

A package that contains a collection of two or more drug products having separate drug identification numbers.

or

A combination of one or more drug products and non-drug products (e.g. empty, pre-packaged syringes, swabs, tourniquet).

 

Drug/device combinations and drug/delivery system products are not considered kits

Lotion

A broad term to describe a liquid or semi-liquid preparation that contains medicinal agents, with solid materials suspended in an aqueous vehicle. Lotions are usually a suspension of solids in an aqueous medium, but may also be emulsions or solutions.

 

Topical, transdermal, vaginal, rectal, otic, ophthalmic

Lozenge

A disc-shaped, solid pharmaceutical form that contains medicinal agents and sometimes flavouring in a hard candy or sugar base. It is intended to be slowly dissolved in the oral cavity, usually for localized effects, although some may be formulated for systemic absorption.

Pastilles, troche

Oral, sublingual

Mouthwash/gargle

An aqueous solution that contains medicinal agents that are swished in the mouth or held in the throat and gargled and subsequently expectorated.

 

Buccal

Ointment

A semi-solid pharmaceutical form that contains medicinal agents consisting of a single-phase base in which solids or liquids may be dispersed.

 

Topical, vaginal, rectal, nasal, transdermal

Pad

A cushion-like mass of soft material that contains medicinal agents.

Pledglet

Topical, transdermal

Paste

A semi-solid pharmaceutical form of thick or stiff consistency that contains medicinal agents and large proportions of solids finely dispersed in the base.

 

Topical, transdermal



Not to be used for toothpaste

Patch

A drug delivery system that contains an adhesive backing and that permits the medicinal agents to diffuse from some portion of it (e.g. the backing itself, a reservoir, the adhesive, or some other component) into the body from the site where it is applied.

 

Transdermal , topical

Patch, extended release

A patch formulated to release the medicinal agents in such a manner to allow a reduction in dosing frequency as compared to that of the medicinal agents presented as a conventional dosage form.

Sustained release, prolonged release, controlled release, timed release

Transdermal , topical

Pellet

A small, sterile and solid mass consisting of a highly purified medicinal agent (with or without excipients) made by the formation of granules, or by compression and moulding.

 

For homeopathic products, use globule

Pencil

A solid paste containing medicinal agents, compacted into a tapered cylinder form imitating a common pencil in shape. It is intended for topical application on the skin or skin adnexa.

 

Topical

Piece, chewable

A solid or semi-solid pharmaceutical form of various shapes (e.g. cube ) that contains medicinal agents and is intended to be chewed and swallowed. It is smaller than a chewable bar, does not qualify as a chewable tablet and is not a gum.

Soft chew, gummy bear, candy

Oral

Plaster

A solid or semi-solid adhesive mass that contains medicinal agents and is spread on a backing material of paper, fabric, moleskin or plastic. Plasters are intended to afford protection and to support and furnish an occlusion and macerating action, and to bring medication into close contact with the skin.

 

Topical

Powder

An intimate mixture of dry, finely divided medicinal agents intended for internal or external use.

 

Oral, topical, inhalation, transdermal

Powder, effervescent

An intimate mixture of dry, finely divided medicinal agents in a dry mixture, usually composed of sodium bicarbonate, citric acid and tartaric acid, that when put in contact with water has the capability to release gas, resulting in effervescence.

 

Oral

Powder, delayed release

An intimate mixture of dry, finely divided medicinal agents formulated to release the medicinal agents at any time other than promptly after administration.

 

Oral, topical, transdermal

Powder for gel

An intimate mixture of dry, finely divided medicinal agents that upon the addition of suitable vehicles yields a gel.

 

Topical, oral

Powder for solution

An intimate mixture of dry, finely divided medicinal agents that upon the addition of suitable vehicles yields a solution.

Drops

Oral, topical, sublingual, rectal, vaginal, transdermal, nasal, otic, ophthalmic, irrigation

Powder for suspension, extended release

An intimate mixture of dry, finely divided medicinal agents that upon the addition of a suitable vehicle yields a suspension (a liquid preparation containing solid particles dispersed in the liquid vehicle). It is formulated to release the medicinal agents in such a manner to allow a reduction in dosing frequency as compared to that of the medicinal agents presented as a conventional dosage form.

Sustained release, prolonged release, controlled release, timed release

Oral, topical

Powder for suspension

An intimate mixture of dry, finely divided medicinal agents that upon the addition of a suitable vehicle yields a suspension (a liquid preparation containing solid particles dispersed in the liquid vehicle).

 

Oral, topical, sublingual, rectal, vaginal, transdermal, nasal, otic, ophthalmic

Powder, metered dose

A powder containing medicinal agents that is situated inside a container that has a mechanism to deliver a specified quantity.

 

Oral, inhalation

Shampoo

A liquid soap or detergent that contains medicinal agents and is used to clean the hair and scalp.

 

Topical

Soap, bar

A solid dosage form in the shape of a bar that contains medicinal agents and is used to cleanse the skin.

 

Topical

Soap, liquid

A liquid dosage form that contains medicinal agents and is used to cleanse the skin.

 

Topical

Solution

A liquid preparation that contains one or more chemical substances dissolved (i.e. molecularly dispersed) in a suitable solvent or mixture of mutually miscible solvents.

Drops

Oral, topical, ophthalmic, nasal, rectal, vaginal, transdermal

Solution, extended release

A liquid preparation containing one or more chemical substances dissolved (i.e. molecularly dispersed) in a suitable solvent or mixture of mutually miscible solvents that is formulated to release the medicinal agents in such a manner to allow a reduction in dosing frequency as compared to that of the medicinal agents presented as a conventional dosage form.

Sustained release, prolonged release, controlled release, timed release

Oral, topical

Sponge

An absorbent pad of folded gauze or cotton that contains medicinal agents.

 

Topical, vaginal

Spray

An aqueous or oleaginous solution, suspension or emulsion that contains medicinal agents in the form of coarse droplets or as finely divided solids to be applied topically, most usually to the nasal-pharyngeal tract or skin.

Aerosol (without propellant)

Inhalation, nasal, topical

Spray, metered dose

An aqueous or oleaginous solution that contains medicinal agents in the form of coarse droplets or as finely divided solids, and consists of a metered dose valve that allows for the delivery of a uniform quantity of spray upon each spray.

 

Inhalation, nasal, topical

Stick

A solid pharmaceutical form that contains medicinal agents dissolved or dispersed in a simple or compound excipient that may dissolve or melt at body temperature. It is intended for local application.

 

Topical

Strip

A long, narrow piece of medicated substance to be applied topically.

 

Topical

Succus

The expressed juice of a plant, for medicinal use.

Juice

Oral

Suppository

A solid body of varying weight and shape adapted for introduction into the rectal, vaginal or urethral orifice of the human body. It usually melts, softens or dissolves at body temperature.

Ovule

Rectal, vaginal

Suppository, extended release

A solid body of varying weight and shape adapted for introduction into the rectal, vaginal or urethral orifice of the human body that is formulated to release the medicinal agents in such a manner to allow a reduction in dosing frequency as compared to that of the medicinal agents presented as a conventional dosage form.

Sustained release, prolonged release, controlled release, timed release

Rectal, vaginal

Suspension

A liquid pharmaceutical form that contains medicinal agents and consists of solid particles dispersed through a liquid phase in which the particles are not soluble.

 

Oral, topical, ophthalmic, otic

Suspension, liposomal

A liquid preparation consisting of an oil phase dispersed throughout an aqueous phase in such a manner that liposomes are formed.

 

Oral, topical, ophthalmic, otic

Syrup

An oral solution containing high concentrations of sucrose or other sugars.

 

Oral

Syrup, extended release

An oral solution containing high concentrations of sucrose or other sugars that is formulated to release the medicinal agents in such a manner to allow a reduction in dosing frequency as compared to that of the medicinal agents presented as a conventional dosage form.

Sustained release, prolonged release, controlled release, timed release

Oral

Tablet

A solid pharmaceutical form that contains medicinal agents and is manufactured by compressing uniform volumes of particles.

Pill, caplet

Oral, sublingual, vaginal

Tablet, chewable

A tablet formulated and manufactured so that it may be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant aftertaste.

 

Oral

Tablet, combined release

A tablet that consists of two or more medicinal agents with different delivery characteristics (e.g. immediate release and extended release).

Tablet, dual release

Oral

Tablet, delayed release

A tablet formulated to release the medicinal agents at any time other than promptly after administration.

Enteric coated, repeat action

Oral

Tablet, effervescent

An uncoated tablet usually composed of sodium bicarbonate, citric acid and tartaric acid that, when in contact with water, has the capability to release gas, resulting in effervescence.

 

Oral

Tablet, extended release

A tablet formulated to release the medicinal agents in such a manner to allow a reduction in dosing frequency as compared to that of the medicinal agents presented as a conventional dosage form.

Sustained release, prolonged release, controlled release, timed release

Oral

Tablet, rapid dissolving

A tablet formulated to disintegrate or dissolve in approximately 15 to 30 seconds in the mouth.

 

Oral

Tea, herbal

Dried herb leaves used to prepare a beverage with therapeutic properties.

 

Oral

Tincture

An alcoholic or hydro-alcoholic solution prepared from vegetable materials or from chemical substances.

 

Oral, topical, otic, ophthalmic

Vapour from liquid

A liquid preparation containing medicinal agents converted into a vapour for administration to the lungs for either a local or systemic effect.

 

Inhalation, nasal

Vapour from solid

A solid preparation containing medicinal agents converted into a vapour for administration to the lungs for either a local or systemic effect.

 

Inhalation, nasal

Wafer

A thin slice of material that contains medicinal agents.

 

Topical

Wipe

A cloth that contains a medicinal agents.

 

Topical

Annex 2. - List of Products Type

  1. Plant, alga or fungus
  2. Non-human animal material
  3. Bacterium (non-living, e.g. tyndallized, spirulina)
  4. Extracts
  5. Isolates
  6. Enzymes
  7. Vitamins
  8. Minerals
  9. Amino acids
  10. Essential fatty acids
  11. Synthetic duplicates
  12. Probiotics
  13. Homeopathic medicines