TGA Process Review

June 13, 2012

THE TGA has launched a process review regarding minor variations to prescription medicines for sponsors. The review applies to changes to an entry of a prescription medicine in the ARTG of the following kinds: corrections to the entry, safetyrelated changes, ‘self-assessable’ quality-related changes and Category 3 quality-related changes. The scope of the review includes: the existing processes that the sponsor undertakes (such as the forms to be filled in), and the existing processes that the TGA undertakes. Extensive consultation with industry about the proposed changes is planned in August and September, and full details of the proposed changes will be made available closer to the consultation period.

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Pharmacy Daily | TGA Process Review

TGA Process Review

Other recent headlines

RACGP slams SA move

PSA’s new vaping criteria

IPA makes room for charity

SEARCH PHARMACY DAILY

Featured video

Recent issues

INDUSTRY JOB VACANCIES