Medicine example – multiple medicinal product

Product Type: Medicine

This is an oral contraceptive, commonly known as a "birth control pill”. These tablets contain two hormones (levonorgestrel and ethinylestradiol) in different dosage represented by the different coloured tablets.

The container is a single blister pack (Component 1 or C1).

The content of the blister pack is mixed.

There are 4 categories of pills (with different ingredients).

These will be represented as component details (D1-D4) further on.

Note:

Data provided as an example on how the healthcare attributes can be populated for a similar product and not meant to represent any product or manufacturer. This is an example and not advice on actual product regulatory information.

Pricing data has not been included on examples

Trade Item Description

GS1 Oral Contraceptive Tablets 28

Trade Item Channel Code

HEALTHCARE

If the UNSPSC Segment level code = 51000000 (Drugs and Pharmaceutical Products), 41000000 or 42000000 (Medical Devices) THEN Trade item Trade Channel Code must be "HEALTHCARE".

Additional Trade Item Classification Code / Description

51181800

UNSPSC Code list can be found in the NPC Cookbook under Product Classifications. Please use version 19.

GPC Category Code

10005845

GPC Code list can be found in the NPC Cookbook under Product Classifications.

Is Trade Item Considered Generic

Y

The generic description of the trade item should be provided for ethical or proprietary medicines only and is made up of the active ingredient, format, and strength.

Generic Description

Ethinyl Estradiol + levonorgestrel

AMT Containered Trade Product Pack Code

700020071000000000

AMT Containered Trade Product Pack (CTPP) is required to be provided for all medicinal/pharmaceutical products both branded and generic. GS1 Oral Contraceptive 30mcg/50mcg + 40cmg/75mcg + 30mcg/125mcg capsule, 28, blister pack. For more information, refer to the Australian Digital Health Agency Webpage.

Label Description

Oral Contraceptive 28

Word-for-word what appears on the packaging label.

Does Trade Item Require Mixing

N

This attribute is used to determine how the product is priced within the Pharmaceutical Benefits Scheme (PBS).

Routes of Administration

ORAL

Routes of Administration expresses the method(s) of administering the product. In pharmacology and toxicology, a route of administration is the path by which a drug, fluid, or other substance is brought into contact with the body.

Healthcare Component Type C1

M (Medicine)

Where Healthcare Component Type is M - Medicine or D – Device, there must be at least 1 component detail (C1D1) for the base unit. These attributes are used to distinguish medications or devices within a multi component or multi medications item e.g., Ingredient(s) plus Strength(s).

Medicine Container Type Code C1

BKLPK - Blister Pack

The type of packaging that immediately surrounds the product.

No of Identical Medicine Containers or Devices C1

 1

For Medicines: The number of times the same container type appears in the packaged product. 
For Devices: The number of times the same device type appears in the packaged product.

Medicine/Device Unit Name (C1D1 – C1D3)

Ingred1/12mg, ingred2/20mg, green

Ingred1/10mg, ingred2/40mg, blue

Ingred1/25mg, ingred2/10mg, light blue

Ingred1/25mg, ingred2/10mg, white

Used to distinguish medications or devices within a multi component or multi medications item.

Unit of Use GTIN (C1D1 – C1D3)

Product Specific Application

Product Specific Application

Product Specific Application

Product Specific Application

There may be multiple components to the actual product which maybe intended for individual issue at point of use. If available, the unit of use GTIN should be provided if available.

Medication Form Code (C1D1 – C1D3)

TAB

TAB

TAB

TAB

The physical structure of the medicine (code list).

Proprietary Medication Dose Form (C1D1 – C1D3)

The name, owned by a company/organization, that describes the physical structure of the medicine. e.g. Caplet

Countable Items (C1D1 – C1D3)

6

5

10

7

Where Healthcare Component Type is M - Medicine or D – Device, there must be at least 1 component detail for the base unit. 

Volume/Weight Unit C1D1 (C1D1 – C1D3)

Volume or mass of a single unit of medication.
Note: If countable items is not used, then Volume/Weight Amount is Mandatory for each component detail.

Referenced Trade Item Type Code

SUBSTITUTED_BY

This attribute maybe used to capture a replacement, substitute, primary alternative or equivalent medicine or device (code list).

Referenced Trade Item GTIN

09322380000000

Manufacturer Declared Reusability Type

SINGLE_USE

Determines if the product is intended for single or multiple uses (code list).

Is Trade Item Cytotoxic

Y

Cytotoxic medications are therapeutic agents known to be highly toxic to cells, mainly through their action on cell reproduction. (e.g., chemotherapy drugs).

Controlled Narcotic Drug Number

Product Specific Application

This number is assigned to products that are classified in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) under Schedule 8 (Controlled Drugs).

Percentage of Alcohol By Volume

Product Specific Application

Percentage of alcohol contained in the base unit trade item.

Trade Item Spirit Class

Product Specific Application

The spirit class determines how a product should be handled and stored.

Alcohol Net Weight + UOM

Product Specific Application

Allergen Type Code

Product Specific Application

Allergen: Level of Containment Code

Product Specific Application

Is Ingredient Active

TRUE

Determines whether the ingredient helps directly in achieving the objectives of the trade item. Repeatable.

Non-food Ingredient Name

Ethinyl Estradiol

Repeatable.

Ingredient Strength + UOM

72 MGM (Milligram)

Used to define the strength of each ingredient in a trade item or unit volume of non-food trade items. Repeatable.

Is Ingredient Active

TRUE

Non-food Ingredient Name

Levonorgestrel

80 MGM (Milligram)

Additional Trade Item Classification System Code = "52"

52

Additional Trade Item Classification Code Value

PBS or RPBS

PBS Formulary Allocation Code

F2

The National Health Act 1953 provides that listed drugs be assigned to formularies identified as F1 or F2. (code list) – Also refer to PBS website.

PBS Item Code

1456P

For more information on the applicable PBS code please refer to the PBS Website. Repeatable.

PBS Manufacturer Code

GS (GS1 for this example)

PBS Manufacturer Codes are created by the Department of Health (DoH) and assigned to manufacturers or suppliers upon their request.

PBS Pack Size

28

The Pack Size(s) associated with the PBS Item.

PBS Schedule Code

GE - General

The PBS schedule that this product appears on. (code list).

PBS Start Date

2021-07-27

The date by which the product becomes available under the PBS.

Additional Trade Item Identification Type Code = "ARTG_ID"

ARTG_ID

Additional Trade Item Identification Type Code > Value

10419

The numeric identifier (ARTG ID) that is allocated to the product by the Australian Therapeutic Goods Administration for a registered or listed product. For more information on the ARTG ID, please visit the Therapeutic Goods Administration Webpage.

Additional Trade Item Classification System Code = "51"

51

Additional Trade Item Classification Code Value

54

The code assigned to a product that reflects its Poison Schedule.

TGA Type

R - Registered

A flag to indicate whether a product is registered or listed with the Therapeutic Goods Administration (code list).

TGA Risk Classification

A category used to gauge the level of potential harm that a patient could experience by using a medical device (code list).

TGA Sponsor

N

A flag to indicate whether the company associated with this catalogue is the registered TGA Sponsor.

Party Role Code = "REGISTERED_AGENT"

REGISTERED_AGENT

Required when the entry for "TGA Sponsor" = No.

Party Name

NPC Pharma Company Pty Ltd

The actual TGA Sponsor’s name, where the company associated with this catalogue is not the TGA sponsor.

Referenced File Type Code = "DRUG_FACT_LABEL"

DRUG_FACT_LABEL

This attribute is used for linking assets like documents, images etc to the product data.

Uniform Resource Identifier

<URL to Drug Fact Label>

Referenced File Type Code = "IFU"

IFU

This attribute is used for linking assets like documents, images etc to the product data.

Uniform Resource Identifier

<URL to Instructions for Use>

Referenced File Type Code = "PRODUCT_IMAGE"

PRODUCT_IMAGE

This attribute is used for linking assets like documents, images etc to the product data.

Uniform Resource Identifier

<URL to your product image or if using GS1 Imaging services>

Referenced File Type Code = "VIDEO”

VIDEO

Uniform Resource Identifier

<URL to your Video>

Suggested Retail Price -> Trade Item Price

30.00

Price as suggested by the manufacturer to end consumer, may or may not appear on packaging

Suggested Retail Price -> Price Basis Quantity + UOM

EA

Suggested Retail Price -> Trade Item Price -> Currency Code

AUD – Australian, Dollars

Suggested Retail Price -> Price Effective End Date

Suggested Retail Price -> Price Effective Start Date

2021-07-27