Understanding packaging definitions for medicines
Guidance to help manufacturers and sponsors navigate packaging terms across the industry, to meet regulatory requirements.
Purpose
Packaging terms are important to know to ensure sponsors and manufacturers are following the rules when labelling their medicines. Therapeutic goods legislation, GS1 General Specifications, PIC/s guide to GMP and ISO 21067-1:2016 all refer to terms for medicine packaging, but the terms don't always align.
The following is helpful guidance for manufacturers and sponsors to help navigate packaging terms across the industry in order to meet regulatory requirements.
Legislation
How the TGA defines packaging
Container
The Therapeutic Goods Act 1989 defines the container as:
'the vessel, bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack, wrapper, cover or other similar article that immediately covers the goods, but does not include an article intended for ingestion.'
When the TGA talks about the container, we are referring to the packaging that comes into direct contact with the product and holds the medicine.
Other sources such as GS1 and GMP use the term 'primary packaging' when referring to the 'container'. For example, a blister pack of capsules is considered a 'container' or 'primary packaging'.
You may also hear this packaging referred to as product-contact packaging or a unit dose (for example one vial of medicine), but some containers may hold many unit doses such as a blister pack of 10 capsules.
Primary pack
The Act defines primary pack as:
'the complete pack in which the goods, or the goods and their container, are to be supplied to consumers'.
When the TGA refers to the primary pack, we mean the packaging that you see sitting on the shelf that is supplied to customers, for example a box of pain relief tablets. This is sometimes referred to as the 'saleable pack'.
'Primary pack' and 'primary packaging' mean different things.
The primary pack may be what other standards refer to as 'primary packaging' or 'secondary packaging', depending on the goods.
'Primary pack' that is the 'container'
When the 'container' is sold with no further packaging this can also be the 'primary pack'.
Examples include:
- sunscreen not sold in a box
- cream tube not in box
- bottle not stored in a cardboard box.
'Primary pack' that is 'secondary packaging'
Where the 'primary pack' does not directly contact the medicine, it is considered 'secondary packaging'.
Examples include:
- cardboard box containing a bottle or a blister pack of tablets or capsules
- bag containing individually wrapped lozenges.
You may also hear this packaging referred to as:
- the saleable pack
- sales unit packaging
- unit of supply.
Tertiary packaging
Bulk packaging for transport purposes is referred to as tertiary packaging.
You may also hear this packaging referred to as:
- shippers
- pallets
- aggregate packaging
- consignments.
Page history
Original publication.
Original publication.