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Prescription medicines registration process

12 August 2021

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Version history

Version history of Prescription medicines registration process
Version Description of change Author Effective date
V1.0 First version Office of Prescription Medicines 1/02/2010
V2.0 Second version to reflect outcomes from the public and stakeholder consultation, the introduction of a separate workflow for generic medicines and the opportunity for applicants to consider all evaluation reports at milestone 3 Office of Prescription Medicines 1/05/2013
V2.1 Addition of link to guidance on orphan drug designations Office of Medicines Authorisation 09/09/2014
V2.2 Update to reflect new legislation Prescription Medicines Authorisation Branch 01/07/2017
V2.3 Updated to reflect Provisional approval pathway Prescription Medicines Authorisation Branch 20/03/2018
V2.4 Minor updates to Submissions Prescription Medicines Authorisation Branch August 2020

Updates to expert advisory review phase

  • Use of the phrase ACM/ACV rather than only ACM
  • Provide additional details regarding the Pre-ACM/ACV responses (within
  • Update timeframes for provision of ACM/ACV minutes in line with current practice (within 5.6.3 &
  • Removal of the Pharmaceutical subcommittee information
  • Expectation for reviewing evaluation reports combined for both applications that attend ACM/ACV and that do not attend ACM/ACV (within
  • Inclusion of information about Decision Summaries (within 5.8.5)
  • Minor edits to increase readability
Prescription Medicines Authorisation Branch August 2021

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