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4 Steps to Achieve Compliant Packaging for Mandatory Regulations

Posted By: SGK August 13, 2018

Over the next two years, prescription 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 pharmaceutical labelling regulations to align with international best practice.

Medicine labels are required to comply with the new rules by 1 September 2020.

What packaging and labelling details are changing?

Active ingredients will need to be more prominent on medicine labels with larger print sizes on the front label. The 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 alter the effectiveness, and to assist consumers in making informed choices. Consumers can expect to see these changes on sunscreen and vitamin supplements too.

READ: 7 Challenges Facing Pharmaceutical Packaging Today

Along with larger font sizes, the new medicine packaging will also include critical health information to increase clarity on what a particular 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 covering up other information.

Australian and New Zealand 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 labeling rules, more allergens (fish, eggs, soy, milk, and tree nuts) will need to be disclosed on non-prescription medicine labels. For prescription drugs, this callout must appear on the label or in the Consumer Medicine Information leaflet with a prompt on the pack.

What does this mean for brands?

To turn these pharmaceutical labelling requirements into a competitive advantage, follow these four steps:

1. 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 process which is GMP compliant.

2. Review your current brand architecture and apply a revised strategy to promote the brand, application, efficacy, claims, and on pack communications.

3. Utilise connected services to develop Rx and OTC compliance packaging with activation of digital communications as part of the overall strategy.

4. Ensure an effective project plan is in place, identifying all SKUs to be developed to ensure compliance to meet the 2020 regulations. This information 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 engage and deliver a complete end-to-end solution. Creative strategy and consultation with regulatory experts within the business enables us to develop clear, concise communications that support brand, regulatory compliance, and technical print aspects.

SGK serves seven of the Top 10 Global Pharma Companies —from design to print, we’re well-versed to develop compliant medication packaging for the mandatory regulatory requirements.

To learn more about the new Australian medicine label regulations, visit the Therapeutic Goods Administration website.