Supplement sample and trial packs: sizes, labels and the rules

What a small pack's label must carry

A sample pack of a listed medicine is labelled to TGO 116, the TGA's labelling standard for non-prescription medicines, in force since 30 September 2026. Its main label carries what any main label does: the name, each active ingredient and its quantity, the dosage form and the quantity in the pack. Our labelling guide covers the full list.

Two of TGO 116's rules matter most for small packs:

• Small containers. A container of 25 mL or less inside a primary pack. Its label must carry, in text at least 1.5 mm high, the name of a listed medicine, the name and quantity of each active, the dosage form, the quantity, the batch number, the expiry date and the sponsor's name as on the primary pack, or a registered trade mark that readily identifies the sponsor.
• Blister and strip packs. They carry the name, the actives and their quantities, the batch, the expiry and the sponsor (or a registered trade mark that readily identifies it). A listed medicine with two or more actives can leave the actives off. Where segments tear off, at least every second segment carries the name, plus the active and its quantity if there is only one active.

A large tablet or capsule usually needs a "Swallow with water" direction and, on many packs, an image at actual size. None of that applies when the primary pack is a small container.

Sampling and the advertising rules

Advertising a listed medicine is governed by the Therapeutic Goods Advertising Code. Under section 25, an advertisement can't contain or offer a free sample, except for the goods the Code names. Before a sample pack is made, we look at how and where it will be given: at an event, in a practitioner's clinic, with an order, or as a paid trial size. Our TGA advertising guide covers the Code, including the rules on incentives and influencers.

The pack in the stability program

The shelf life on a label rests on stability data for the product in its pack. TGA guidance says ongoing stability testing is of the finished packed product, that products grouped in one study should share the same primary packaging materials, and that a change to a product needs a risk assessment to decide whether a new study is needed. A different pack, such as a glass bottle, a particular plastic bottle, a blister or a laminated tube, may need its own study. So a sample pack in a different material from the full size is planned into the stability protocol from the start. More in our stability testing guide.

Child-resistant packaging by pack size

TGO 95 sets child-resistant packaging requirements by substance and, for some, by the total in the pack. Iron, for example, triggers them when a pack holds more than 250 mg of elemental iron, unless it is a divided preparation in which the iron is combined with other actives and each dose has 5 mg or less. Because the thresholds are per pack, each pack size is checked on its own. More in packaging and labelling.

Choosing the format

• A smaller count of the same capsule or tablet. The simplest trial pack: the same product in a smaller bottle or blister, made in the same run as the full size.
• Sachets and stick packs. One dose each, nothing to measure. They need large minimums from the packaging supplier, typically around 150,000 sachets, so they suit an established product more than a launch (powders and sachets).
• A short-course pouch. A pouch sized to a course of use, such as a 14-day travel pack.

We quote the formats side by side, so the choice rests on the cost per pack as well as the customer.

From our records

• Arxi's preconception supplement: a TGA-listed preconception capsule. We later added a 7-day sample pack for events and sampling. Three production orders since 2024.
• An eye-health formula: a 60-count pack and a trial pack to drive trial, both manufactured in both production runs. Design to production order in under seven weeks, and reordered a year later.
• The Belly Solution: a travel gut-health powder in a 14-day pouch, with a 36-month stability program. More than 30 new pharmacy stockists in the first week of a national distribution trial.