The Office of Drug Control (ODC) has recently announced changes to the cost recovery arrangements for the Medicinal Cannabis Scheme as the result of amendments to the Narcotic Drugs (Licence Charges) Regulations 2016. The changes came into effect from 15th July 2020. What is the Medicinal Cannabis Cost Recovery Framework? The Medicinal Cannabis Scheme implements…
To comply with the requirements of GMP, manufacturers must ensure that any material or service providers that they use are able to meet strict quality standards. This is due to the potential impact of materials or services on the quality of a final therapeutic product. Achieving this standard requires that a number of procedures are…
The TGA recently announced an update to the Uniform Recall Procedure for Therapeutic Goods (URPTG) has been implemented, taking effect on 30 June 2022. The URTPG: instructs sponsors about how to efficiently and effectively remove marketed therapeutic products that pose a potential risk to users from the distribution chain outlines a consistent approach for undertaking…
Certain medical devices utilize animal materials in their manufacture to provide performance characteristics that are more advantageous than non-animal-based materials. The use of animal material, however, carries the risk of transmitting infectious diseases when it is improperly collected, stored or processed (e.g. prion diseases). Transmissible Spongiform Encephalopathy (TSE) is a prion disease that can affect…
Every year, the Therapeutic Goods Administration (TGA) undertakes a comprehensive targeted consultation by engaging with peak therapeutic industry bodies in regard to the TGA fees and charges being proposed for the upcoming financial year, including TGA application fees for pharmaceutical products/biologicals, chemicals, and medical devices. The TGA is required to recover its costs for all…
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