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S38 guidelines for Australian manufacturing licences covering multiple manufacturing sites

13 October 2021

The Therapeutic Goods (Multi-Site Manufacturing Licences) Guidelines of 2020 provides guidance on when a manufacturing site can be included as a secondary site for the manufacture of blood, blood components, plasma, haematopoietic progenitor cells or human tissue, or other therapeutic goods (not medical devices). The guidelines set out the criteria which must be met for any additional manufacturing sites to be included as secondary sites on new or existing manufacturing licences.