Page 26 - Packaging News Magazine Sep-Oct 2018

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PHARMA PACKAGING
www.packagingnews.com.au
September-October 2018
A new prescription
Changes to medicine labelling rules will require greater clarity on packaging. Michael De Bari from Schawk Australia shares his tips for preparing to comply with the new regulations.
OVER the next two years, pre- scription and over-the-counter medicine labels in Australia and New Zealand will change.
Due to consumers’ demand for more informed choices about their medicines, the Therapeutic
Goods Administration is requiring new regulations to align with international best practice, and medicine labels are required to comply with the new rules by 1 September 2020.
Active ingredients will need to be more prominent on medicine labels, with larger print sizes on the front label, and active ingredients will be positioned on the package under the brand name on the front label.
This will ensure consumers are not mixing medicines that could al- ter the effectiveness, and assist con- sumers in making informed choices.
Consumers can expect to see these changes on sunscreen and vitamin supplements too.
Along with larger font sizes, the new medicine packaging will also include critical health information to increase clarity on what a particu- lar product is to be used for.
For prescription drugs, the new rules indicate there will need to be extra space for pharmacists to attach their dispensing labels without cov- ering up other information.
ABOVE: Active ingredients will need to be more prominent on medicine labels, with larger print sizes on the front label.
BELOW: Schawk Australia’s Michael De Bari.
In Australian and New Zealand all medicine labels will soon be required to include details about:
• Storage conditions: To reduce the
risk of storing medicine incorrectly, labels will be required to include directions on how to store a product.
• Expiration date: Consumers are familiar with the use-by date on food products – now medicine labels in Australia will be required to include the expiry date, to protect consumer from expired or unsafe medicines.
• Batch number and company address: The batch number, name, and address of the supplier will be included – to be used to trace medicine and easily manage recall efforts. Medicines sold in Australia will display either an AUST R number or an AUST L number. AUST R (registered) medicines include all prescription-only medicines and many over-the-counter medicines. AUST L (listed) medicines are lower risk, self-medication products, such as fish oils, multivitamins, and herbal and homeopathic products.
• Allergens: Under the new labelling rules, more allergens (fish, eggs, soy, milk, and tree nuts) will need to be disclosed on non-prescription med- icine labels. For prescription drugs, this callout must appear on the label or in the Consumer Medicine leaflet with a prompt on the pack.
WHAT DOES THIS MEAN FOR BRANDS?
To turn this mandatory regulation into a competitive advantage, follow t1hese four steps:
Engage with a business partner that can enable development of packaging that is compliant and ensures brand guardianship – with compliance and speed to market as the basis of the
2 GMP-compliant process. Review your current brand architecture and apply a revised strategy to promote the brand, application, efficacy, claims,
3 and on-pack communications. Use connected services so you can develop Rx and OTC com- pliance packaging with activa- tion of digital communications
4 as part of the overall strategy. Ensure an effective project plan is in place, identifying all SKUs to be developed in order to ensure compliance to meet the 2020 regulations. This informa- tion will help to identify and manage the process steps of development, submission and print-to-pack timelines.
A pharmaceutical marketing business partner such as SGK Health can support the process with subject matter experts to en- gage and deliver a complete end-to- end solution. ■