What does it mean for Australian Medicine Labels?
In a competitive world of life sciences, releasing a medicine (innovator/reference/generic) means the first step towards success for organizations. Having so much of significance inhered in, organizations must take care of the medicinal information they ought to provide through labels. The information provided on labels should not only ensure the safety and efficacy but should also be clear and accurate. In order to enable patients or end users make informed decisions, labels must provide up-to-date medicinal information that is aligned with the international best practices.
Emphasizing the same, Australian Government Department of Health, the Therapeutic Goods Administration (TGA) has announced new Labeling requirements which are set to be effective from 31st August 2016. With the new labeling requirements for Australian Medicines coming after so many years, a four year transition time has been given to be compliant with the improved standards. That suggests the Sponsors will have enough time for transition and from 1 September 2020, their new medicine labels will need to comply with the new improved regulations.
The new standards will be available on the Federal Register of Legislation on 17th August 2016, thus making it an easy process for the Sponsors to review them before they come into effect.
As furnished on the TGA web portal the significant changes anticipated are:
- Active ingredients are expected to be prominent and easy to find
- Most of the OTC medicines expected to have a Critical Health Information panel to help organizations find important information about their medicines
- Non-prescription medicines: substances, inclusive of crustacea, fish, eggs, soya, milk and tree nuts, which could cause allergic reaction are expected to be listed on labels
- Prescription medicines: required to declare these substances on the label (otherwise a statement linking to the CMIL [Consumer Medicine Information leaflet] should be provided)
- Designated spaces for dispensing labels are expected to be provided for prescription medicines. Having a defined space, these labels are expected to ensure that the other information present on is not covered. The labels applied by the Pharmacists will include important information like name, dosage instructions.
Alongside, the TGA has also announced there are no print formats yet for the upcoming changes and they will be made available in late 2016. Having said that, as the medicine label changes are still being developed, manufacturers are recommended to be abreast with the region-specific Regulatory labeling insights and consult a global labeling partner for updated best practices and compliant Regulatory labeling know-how. Be informed.