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Prescription medicines registration process
Phase 8: Post-decision
During the post-decision phase, administrative and regulatory activities are completed.
5.8.2 Milestone 8
Administrative and regulatory activities are completed. Any outstanding payments are finalised (if applicable) and the ARTG entry is finalised.
5.8.3 Key dates
The post-decision phase commences when the applicant is notified of the delegate's decision.
The post-decision phase is completed by the end of the month following the delegate's decision.
Note: If an appeal is lodged prior to milestone 8, the milestone will be delayed until all appeal activities are complete. Under section 60 of the Act, an appeal by the applicant must be lodged within 90 days of notification of the decision.
5.8.4 ARTG registration
A new Register entry3 can only be included on the ARTG once the applicant provides a patent certificate or notice (section 26B(1) of the Act) to the TGA (see section 25(4) of the Act).
The TGA will check that the provisional ARTG record (originally provided by the applicant at dossier lodgement and updated during evaluation) matches the approved product details. The provisional ARTG record will become the ARTG Record of Registration.
The applicant must notify the TGA of the actual date of marketing commencement and meet other conditions of registration outlined in the delegate's decision letter.
3A new registration (or new Register entry) is one that requires a new ARTG entry by reason of being 'separate and distinct goods' under s.16 of the Therapeutic Goods Act 1989. This includes new chemical entities, new strengths, new dosage forms, different directions for use, formulation changes, changes in trade name, and extensions of indication. However, not all new registrations will result in the allocation of a new AUST R number if they are taken to be grouped by reason of the Therapeutic Goods (Groups) Order 2001.
5.8.5 Medicines information
After registration medicines information about the product and the decision process will be made available to the public through the TGA website. This information will be published as:
- an Australian Public Assessment Report (AusPAR)
The AusPAR provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application. The AusPAR is drafted during the post-decision phase and sent to the applicant for review prior to publication on the TGA website. Details of the contents, rules, and activities associated with an AusPAR are provided in Australian public assessment report for prescription medicines guidance, accessible on the TGA website
- an Australian Prescription Medicine Decision Summary
The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the ARTG. Australian Prescription Medicine Decision Summaries are drafted during the post-decision phase and published on the TGA website.
- product information (PI)
Product information document(s) in the approved form must be lodged by the applicant with the TGA within 2 weeks of the date of registration of the product(s).
- consumer medicines information (CMI)
CMI document(s) must be lodged with the TGA:
- for new product(s) - prior to first supply of the product(s)
- for variations to existing products - within 2 weeks of the date of approval of the variation.
5.8.6 What happens if an applicant misses a key date?
The post-decision phase for new register entries cannot be completed unless the section 26B(1) Certificate required in relation to patents is provided by the applicant.