Secondary and tertiary packaging: after the bottle, the carton and the case
A medicine reaches the pharmacy in three nested packages: the bottle that touches it, the carton that bears its name, the case that carried it. Each has a role, and they are not all governed by the same rules.
By Tecmom editorial team · 2 min read
Three levels, three roles
Primary packaging is in contact with the product: bottle, pill container, tube, blister. It protects the medicine from moisture, oxygen or light; see our article on primary packaging.
Secondary packaging groups or surrounds the sales unit: the folding carton, the leaflet, sometimes an insert. It does not touch the medicine. Tertiary packaging is for transport and storage: shipping cases, pallets, stretch film.
The carton, carrier of information
European medicines law distinguishes immediate packaging from outer packaging. Most of the mandatory particulars appear on the latter: name of the medicine, composition, batch number, expiry date, method of administration.
For most prescription medicines, the Union has also required since 2019 two safety features on the outer packaging: a unique identifier, printed in a DataMatrix code, and a device that shows whether the carton has been opened. See our articles on counterfeit medicines and tamper-evident packaging.
The case, which protects during the journey
Tertiary packaging never meets the patient. Yet it has to withstand shocks, stacking and sometimes temperature. Good distribution practice requires medicines to be transported in conditions that preserve their quality, and it is first the case and the pallet that ensure this.
A well-designed bottle can lose its seal if it travels on its side under too heavy a load. The choice of bottle and the choice of case are made together.
What this means for the bottle
The bottle is drawn to fit the carton that will hold it: diameter, height, shoulder shape. A carton that is too wide lets the bottle move; one that is too tight damages the cap during cartoning.
The European packaging regulation, the PPWR, also covers these three levels, as sales, grouped and transport packaging, with narrower exemptions for the last two; see our article on the PPWR.
The bottle protects the medicine, the carton names it, the case carries it. Good packaging is packaging whose three levels were designed in conversation.
Glossary
- Primary packaging
- Packaging in direct contact with the medicine.
- Outer packaging
- The packaging in which the immediate packaging is placed, often a carton.
- Tertiary packaging
- Transport and storage packaging: shipping case, pallet.
- Unique identifier
- A code specific to each pack, printed in a DataMatrix, used to check its authenticity.