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Listed and assessed listed medicines: Application and submission user guide

24 July 2019

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Preparing to make an application

Useful information for preparing your application can be found in the TBS portal under 'Public TGA information'. These include:

  • Code Tables
  • Ingredients
  • Ingredients – Proprietary
  • Indications for Listed Medicines

The code tables provide terminology for use in product applications. Data in certain drop-down lists in a listed medicine application is populated from Code Tables. Sponsors can view this information prior to creating an application by selecting the 'Code Tables' in the TBS navigation panel.

screenshot showing Code Tables under Public TGA Information in the TBS portal

Codes Tables that are most useful for preparing a listed medicine application are:

  • Product Code
  • Dosage Form Group
  • Dosage Forms
  • Manufacturing Steps
  • Manufacturing Steps Group

Note: The Code Tables display information for all type of applications e.g. Listed medicines, Non-Prescription Medicines and Prescription Medicines. Therefore some of the information found in the Code Tables is not applicable to a Listed Medicine application.

Product Code

Select the product code that best describes the type of product being submitted from the drop down list. Product codes that can be used in a listed medicine application are:

Type Description Requirements

Other Products

The most commonly used product code which is subject to all the standard requirements under section 26A and 26AB of the Act.

There are no specific exemptions. Used to list products that only contain standard active ingredients, standard excipients and proprietary ingredients.

Must not contain homoeopathic ingredients.

Sunscreens Only

Must only contain active ingredients which are specifically permitted for use in sunscreen preparations.

Must comply with the sunscreen standard

Homoeopathic Products Only

There are no specific exemptions.

Used to list products that only contain homoeopathic ingredients.

Must not contain standard active ingredients.

Homoeopathic / Other Combination Products

There are no specific exemptions.

Used to list products that contain both homoeopathic and standard active ingredients.

Permitted to contain both homoeopathic and standard active ingredients.

Medicated Soap - Bar

As per Item 16 of Schedule 7 of the Regulations, medicated soaps other than liquid medicated soaps

Exempt from the operation of Part 3 3 of the Act unless supplied as pharmaceutical benefits

Homoeopathic ingredients are not permitted

Medicated Space Spray

As per Item 16 of Schedule 7 of the Regulations, medicated space sprays where the medication consists only of volatile oils and their constituents

Exempt from the operation of Part 3‑3 of the Act unless supplied as pharmaceutical benefits

Only permitted for use when dosage form is 'Nasal Drops – Solution' and route of administration is 'nasal'

Homoeopathic ingredients are not permitted

Medicated Throat Lozenge

As per Item 15 of Schedule 7 of the Regulations, medicated throat lozenges, where the medication consists only of volatile oils and their constituents either alone or in combination with ascorbic acid or its salts

Exempt from the operation of Part 3‑3 of the Act unless supplied as pharmaceutical benefits

Only permitted for use when dosage form 'lozenge' and route of administration 'buccal, oral, or sublingual'

Homoeopathic ingredients are not permitted

Uncompounded BP Substances

When used as a standard active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia as in force or existing from time to time.

Cannot be combined with other ingredients and must comply with a monograph of the British Pharmacopoeia that does not related to a compounded substance.

Manufacturers

Listed medicines must be manufactured in accordance with Good Manufacturing Practice (GMP) (unless they are exempt from manufacturing requirements).

You must ensure that your manufacturer has a licence or clearance for the steps of manufacture required for your type of medicine and dosage form.

Manufacturing steps

There are six manufacturing steps that can be undertaken for a listed medicine application. Five of these steps are mandatory. Each step can be undertaken by more than one manufacturer but all five steps must be covered by a manufacturer.

Manufacturing step Mandatory

Manufacture of dosage form

Yes

Packaging and labelling

Yes

Release for supply

Yes

Secondary packaging

No

Testing chemical and physical

Yes

Testing microbial

Yes

The system will not validate and consequently not allow the medicine to be listed if the manufacturer does not hold a valid licence/certificate with the exact manufacturing step match, unless they have been licenced for a manufacturing step group which contains the specific step.

Further information about what is covered by a particular manufacturing step group or dosage form group can be found in the relevant TBS Code Table.

The following product codes are exempt from including manufacturers in the entry on the Register under Schedule 7 of the Therapeutic Goods Regulations 1990:

  • Medicated space spray;
  • Medicated throat lozenge;
  • Medicated soap bar.
Manufacturer's licence or clearance – Product details

The product details of the manufacturer's licence/clearance will designate the dosage form, product category and manufacturing step.

For listed medicines and assessed listed medicines:

  • The product category can be either Registered Therapeutic Good or Listed Therapeutic Good;
  • The manufacturing step must be one of the six described in the above manufacturing step table or be a manufacturing step group that includes one of the six described steps.

    For example, the 'Finished Product Manufacturer' group includes the following individual manufacturing steps: 'Release for supply', 'Secondary packaging', 'Manufacturer of dosage form', 'Testing chemical and physical', 'Testing microbial' and 'Packaging and labelling';

  • The Dosage Form must be one of the Dosage forms described in the below Dosage forms table or it can be a dosage form group which includes the dosage form that you intend to use in your listed medicine application.

Dosage forms

The dosage form is the pharmaceutical form in which a product is presented for therapeutic administration, e.g. tablet or cream. Select the dosage form that best suits the application being submitted from the drop down list.

In an application for a GMP licence or GMP clearance, single or group items can be selected. For example, the single dosage form 'Liquids' or the group dosage form 'Liquids Group'.

Dosage forms that can be used in a listed medicine application are:

Short description Long description

Application

A liquid or semi-liquid preparation containing one or more active ingredients intended for application to the skin.

Bar, soap

A solid preparation derived from the action of a solution of alkali on fats or oils of animal or vegetable origin and containing one or more active ingredients in bar form.

Block

A solid (food) substance usually chocolate, serving as a vehicle for one or more active ingredients.

Capsule, enteric

A capsule prepared in such a manner that the shell, or the pelletised contents, resists the action of the gastric fluid but is attacked by the intestinal fluid to release the contents.

Capsule, hard

A capsule with a hard shell consisting of two prefabricated cylindrical sections one of which fits over the other. The active ingredients are usually in solid form.

Capsule, modified release

A capsule in which the rate or place of release of the active ingredients in the gastrointestinal tract has been modified.

Capsule soft enteric

A capsule, the contents of which are liquid or semi-liquid. The shells are usually thicker than those of hard capsules and consist of a single part with an enteric coating.

Capsule, soft

A capsule, the contents of which are liquid or semi-liquid. The shells are usually thicker than those of hard capsules and consist of a single part.

Cream

A homogeneous, viscous or semi-solid preparation, usually an emulsion, consisting of a solution or dispersion of one or more active ingredients in low proportions in a suitable base.

Collodion

A liquid preparation usually containing pyroxylin and one or more active substances in a mixture of volatile solvents, usually ether and ethanol, intended for application to the skin. When allowed to dry, a flexible film is formed at the site of application.

Ear Drops, emulsion

A dispersion of an oily liquid in an aqueous liquid either of which may contain dissolved solids, in which the aqueous liquid forms the continuous phase. Solids may be suspended in the emulsion.

Ear Drops, powder for

One or more active ingredients in a dry form to be reconstituted for use as ear drops

Ear Drops, solution

A liquid preparation composed of or containing one or more active ingredients dissolved in a suitable vehicle.

Ear Drops, suspension

A liquid preparation containing one or more active ingredients dispersed as solid particles throughout a liquid phase. In addition it may contain other active ingredients which are dissolved.

Enema

A liquid preparation composed of, or containing, one or more active ingredients for rectal administration.

Essential Oil

Essential oil

Gel

A semi-solid preparation usually consisting of a solution or dispersion in a suitable base, prepared with the aid of a suitable gelling agent.

Granules, effervescent

Granules which evolve carbon dioxide when added to water. They are intended to be dissolved or dispersed in water before administration.

Granules, enteric-coated

Granules which resist the action of gastric fluid but are attacked by intestinal fluid to release the active ingredients.

Granules, modified release

Granules in which the rate or place of release of active ingredients in the gastrointestinal tract has been modified.

Granules

A preparation of one or more active ingredients usually in the form of irregular particles 2mm to 4mm in diameter. Some granules are intended to be dissolved or dispersed in water before issuing or before taking; others are chewed or placed on the tongue and swallowed with a draught of water.

Gum, chewing

A preparation containing one or more active ingredients in a gum base, to be chewed and subsequently discarded.

Herb, dried

Dried plant or parts of plants including mixtures of such, used for the extemporaneous preparation of infusions, decoctions or similar preparations for therapeutic use by oral administration.

Inhalation, conventional

A preparation composed of, or containing, active ingredient(s) which when vaporised or dispersed in a suitable manner (eg. hand actuated pump, nebuliser etc.) is intended to release the constituents for inhalation.

Inhalation, powder for

A powder preparation composed of, or containing, active ingredients which when dispersed in a suitable manner is intended to be self-administered by inhalation via the nasal or the oral route for local or systemic effect. It is usually inhaled in controlled amounts.

Inhalation, pressurised

A metered dose preparation usually consisting of a solution, suspension or emulsion of one or more active ingredients held under pressure with a suitable propellant or a suitable mixture of propellants. They are intended to be inhaled in controlled amounts and are delivered by the actuation of an appropriate metering valve.

Inhalation

A preparation composed of, or containing, active ingredients which, when vaporised or dispersed in a suitable manner, is intended to be administered into the lungs or into the nasal, paranasal or ethmoid sinuses via the nasal or oral respiratory route. Inhalations may be intended for local or systemic effect.

Insufflation

A powder containing one or more active ingredients usually diluted with a suitable inert powder. It is intended for introduction into the ear, nose, throat, body cavities or wounds.

Liquid, multipurpose

A liquid (or oily) preparation composed of, or containing one or more active ingredients intended for multipurpose use, e.g. aroma therapy oils can be used for inhalation, topically or orally.

Liquids

liquids

Liniment

A liquid or semi-liquid preparation composed of or containing one or more active ingredients intended to be applied to the unbroken skin with friction.

Lotion

A liquid or semi-liquid preparation composed of or containing one or more active ingredients usually intended to be applied to the unbroken skin without friction.

Lozenge

Lozenge: a hard, solid, single-dose preparation intended to dissolve or disintegrate slowly in the mouth when sucked. They contain one or more active substances usually in a flavoured base containing sweeteners.

Mouthwash

An aqueous solution of one or more active ingredients intended, usually after dilution with warm water, for use in contact with the mucous membranes of the oral cavity, including gargling.

Nasal Drops, emulsion

A dispersion of an oily liquid in an aqueous liquid either of which may contain dissolved solids, in which the aqueous liquid forms the continuous phase. Solids may be suspended in the emulsion.

Nasal Drops, powder for

One or more active ingredients in a dry form to be reconstituted for use as nasal drops

Nasal Drops, solution

A liquid preparation composed of or containing one or more active ingredients dissolved in a suitable vehicle.

Nasal Drops, suspension

A liquid preparation containing one or more active ingredients dispersed as solid particles throughout a liquid phase. In addition it may contain other active ingredients which are dissolved.

Ointment

A semi-solid preparation intended for topical use, usually consisting of a solution or dispersion of one or more active ingredients in low proportions in a suitable base, usually non-aqueous.

Oral Liquid, powder for

One or more active ingredients in a dry form to be reconstituted for use as an oral liquid.

Oral Liquid, solution

A liquid preparation composed of or containing one or more active ingredients dissolved in a suitable vehicle.

Oral Liquid, suspension

A liquid preparation containing one or more active ingredients dispersed as solid particles throughout a liquid phase. In addition it may contain other active ingredients which are dissolved.

Oral Liquid

A preparation usually consisting of a solution, a suspension or an emulsion of one or more active ingredients in a suitable vehicle. They are intended to be swallowed either undiluted or after dilution.

Paint, concentrated

A liquid which must be diluted with another liquid in order to prepare a paint.

Paint, powder for

One or more active ingredients in a dry form to be reconstituted for use as a paint.

Paint

A liquid preparation containing one or more active ingredients for application to broken skin or mucous surfaces.

Paste

A semi-solid preparation for external application usually containing a high proportion of finely powdered active ingredients mixed with soft or liquid paraffin or with a non-greasy base made with glycerol, mucilage or soap.

Pastille

Pastille: a soft, flexible, solid, single-dose preparation intended to dissolve slowly in the mouth when sucked. It contains one or more active substances in a flavoured base containing natural or synthetic polymers or gums and sweeteners.

Patch, dermal

A system containing active ingredients which is affixed to the skin and is intended to produce a local effect by diffusion of the active ingredients to the skin.

Pessary, compressed

A solid preparation, generally similar to an uncoated tablet, but intended for vaginal administration. Also known as vaginal tablet.

Pessary, modified release

A pessary in which the rate of release of active ingredients in the vagina has been modified.

Pessary, moulded

A solid preparation, prepared by allowing a liquefied mass to cool in a mould of suitable size and shape. It contains one or more active ingredients and is intended for vaginal administration.

Pessary, shell

A solid preparation, similar to a soft capsule, but intended for vaginal administration. Also known as vaginal capsule.

Pessary

A solid preparation containing one or more active ingredients intended for vaginal administration.

Pill

A spherical or ovoid solid preparation containing a unit dose of one or more active ingredients for oral administration.

Powder, dusting

A finely divided powder composed of or containing one or more active ingredients intended for application to the skin, mucous membranes or wounds.

Powder, oral

A finely divided powder composed of, or containing one or more active ingredients for oral or nasogastric administration, generally with water. The dose is obtained either by measuring a volume of the powder or from an individual container e.g. sachet, paper tube or vial.

Powder

A mixture of solid, finely divided substances containing one or more active ingredients intended for internal or external use.

Slice

A thin piece cut from a larger portion of bulk raw material, usually of herbal or biological origin.

Solution, powder for

One or more active ingredients in a dry form to be reconstituted in a suitable liquid for use as a solution.

Solution

A liquid preparation composed of, or containing, one or more active substances dissolved in a suitable vehicle.

Spray, nasal

Spray, nasal

Spray, pressurised

A liquid preparation usually consisting of a solution, suspension or emulsion containing one or more active ingredients held under pressure with a suitable propellant or a suitable mixture of propellants. They are intended for local application and are delivered by the actuation of an appropriate valve.

Spray, solution

A liquid preparation for application after dispersion with a suitable device other than aerosol.

Spray, suspension

A liquid preparation containing one or more active ingredients dispersed as solid particles throughout a liquid phase. In addition it may contain other active ingredients which are dissolved.

Spray

A liquid preparation for application after dispersion with a spraying device.

Stick, lip

A solid preparation containing one or more active ingredients in stick form for application to the lips.

Stick

A solid preparation containing one or more active ingredients in stick form.

Suppository, compressed

A solid preparation generally similar to an uncoated tablet, but intended for rectal administration.

Suppository, moulded

A solid preparation, prepared by allowing a liquefied mass to cool in a mould of suitable size and shape. It contains one or more active ingredients and is intended for rectal administration, usually as a single dose.

Suppository, shell

A solid preparation, similar to a soft capsule, but intended for rectal administration, also known as a rectal capsule.

Suppository

A solid preparation containing one or more active ingredients intended for rectal administration, usually as a single dose.

Suspension, powder for

A finely divided powder composed of, or containing, one or more active ingredients to be reconstituted in a suitable liquid for use as a suspension.

Suspension

A liquid preparation composed of, or containing one or more active substances suspended in a suitable vehicle. It may also contain dissolved active substances.

Tablet, chewable

A tablet with a palatable formulation designed to be chewed rather than swallowed whole.

Tablet, dispersible

A tablet which rapidly produces a uniform dispersion in water and is intended to be dispersed prior to administration.

Tablet, effervescent

A tablet generally containing acid substances and carbonates or bicarbonates which react rapidly in the presence of water to release carbon dioxide. It is intended to be dissolved or dispersed in water before administration.

Tablet, enteric coated

A tablet covered with one or more layers of coatings intended to resist the gastric fluid but permit disintegration in the intestinal fluid.

Tablet, film coated

A tablet surrounded by a thin layer of various substances usually polymeric in nature.

Tablet, gelatin coated

A tablet surrounded by a layer of gelatin with or without other substances.

Tablet, modified release

A coated or uncoated tablet in which the rate or place of release of the active ingredients in the gastrointestinal tract has been modified.

Tablet, multilayer

A compressed tablet comprising two or more layers of different composition. The layers may be concentric (compressed coated) or parallel.

Tablet, orally disintegrating

A tablet that is intended to disintegrate rapidly on contact with siliva in the mouth. Tablet, orally disintegration approved as a new dosage form in AAN OOS 20/2002 meeting - 18 July 2002.

Tablet, soluble

An uncoated tablet that is intended to be dissolved in water prior to administration. The solution produced may be slightly opalescent due to excipients used in the manufacture of the tablet.

Tablet, sugar coated

A tablet surrounded by a layer of sugar with or without other substances.

Tablet, uncoated

A compressed solid preparation containing a unit dose of one or more active ingredients for oral administration. The tablet is not coated and not multilayer.

All therapeutic goods containing products of animal origin must comply with the Ph. Eur general monograph 1483: Products with risk of transmitting agents of animal spongiform encephalopathies. The assessment for animal derived material must be against the principle and requirements detailed in the Ph. Eur monograph, and can be conducted:

  • For low risk materials, by self-assessment; and
  • For all other materials, by TGA evaluation.

Additional information can be found Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure.

You may need a pre-clearance prior to starting your application.

Subsection 9D(1) of the Act provides for variations to be made to an entry on a set of limited and prescribed circumstances. These circumstances include where information included in the register is incomplete or incorrect as a result of a mistake at the time of listing.

Before you apply, you should review the Guidance on product changes for listed medicines to identify the relevant change type. If the change type is a 'variation' or 'correction' for a general listed medicine, you should consider submitting the change as a standard variation application (rather than a 9D(1) Variation) as this will be approved automatically by the system and the fee will be equal to or less than the fee for a 9D(1) Variation.

Where a listing has been incomplete or incorrect at time of listing, you can apply online through the TBS portal for a 9D(1) variation. Please ensure that all 9D(1) changes are made to your product within this application via the portal.

As part of this application, you will need to provide the following information:

  • A copy of the original signed and dated product specifications showing the formulation of the medicine at the time of listing
  • Evidence of how the mistake happened
  • Advice of whether the product has already been manufactured and sold in Australia.

Once payment has been received, a delegate will review the changes made in the application, the description of changes and the supporting documentation. If your application is approved these changes will be written to the register.

Please note that your application will be assessed to ensure that your changes will not compromise the safety, quality or efficacy of your product. The delegate will also need to be satisfied that the changes do not mean that the good is separate and distinct to the manufactured medicine (as per subsection 16(1A) of the Act).

What if I have other changes to make?

The delegate will only consider changes that meet the definition of subsection 9D(1) of the Act in this application. If you have other changes to make, please submit them separately either:

  • before creating the draft application for the 9D(1) Variation; or
  • after the decision has been finalised for the 9D(1) Variation and has written to the ARTG entry.

Please note: if a second draft variation application is created before the first application has written to the ARTG entry, the second application will overwrite changes in the first application.

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