Registered medicines are those that are required to be sterile or contain ingredients or indications not permitted for listed medicines. This category typically encompasses both over-the-counter (OTC) and prescription products.
The Australian registered medicine category typically encompasses both over-the-counter (OTC) and prescription products. Registered medicines are not subject to the strict compositional and marketing limitations for listed medicines, but pre-marketing assessment of the safety, efficacy, and quality of the product is required before a registered medicine may be sold. NHP Consulting can prepare/submit applications for registered medicines to the TGA, including the assembly of evidence packages for health claim substantiation, safety and efficacy. We can also review promotional materials (labels, packaging, website, radio/TV advertisements) to ensure compliance with the Therapeutic Goods Advertising Code.
NHP Consulting will provide all regulatory documentation to achieve market compliance for the Australian marketplace.