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Consultation: Minor variations to prescription medicines: guidance and application forms

10 December 2012

This consultation closed on 22 February 2013.

Consultation documents

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Guidance: Minor variations to registered prescription medicines: chemical entities

Guidance: Minor variations to registered prescription medicines: biological medicines

Application form: Request to correct an entry under subsection 9D(1)

Application form: Request to vary an entry under subsection 9D(2) (safety-related request)

Application form: Request to vary an entry under subsection 9D(3) (self-assessable request)

Application form: Request to vary an entry under subsection 9D(3) (Category 3 application)

Application form: Quality-related variation under section 23 (self-assessable request)

Application form: Quality-related variation under section 23 (Category 3 application)

Invitation to comment

The TGA sought comments from interested parties on proposed revisions to guidance documents and proposed new application forms for making minor variations to prescription medicines.

Timetable

Documents were released for consultation on Monday 10 December 2012.

Interested parties responded by close of business Friday 22 February 2013. An extended period was provided for this consultation, in recognition of the overlap with the December/January holiday period, and due to the technical complexity of the draft guidance documents.

About the consultation

The TGA prepared updates to two appendices of the Australian Regulatory Guidelines for Prescription Medicines (Appendix 12 and Appendix 13) in order to increase the useability of the guidelines and to ensure the information provided reflects regulatory requirements. The revised documents differ from the existing guidance in several ways:

  • new material is included about making corrections to ARTG entries and safety-related variations
  • the material about different types of quality-related variations to prescription medicines is enhanced
  • clearer information is included about TGA requirements and decision-making processes
  • information is included about revised business processes implemented in 2013.

New application forms for making different types of minor variations to prescription medicines have been prepared. The purpose of these new forms is:

  • to help sponsors with making the correct type of request
  • to help the TGA to process each request as quickly as possible.

The TGA sought comment from industry and other interested parties on the revised guidance and new application forms. Feedback received through the consultation process will help ensure that the documents are easy to use and contain all the necessary information to help sponsors with making applications and requests to the TGA, and for decisions to be made by the TGA.

Background

On 24 September 2012, the TGA published a review of business processes for making minor variations to prescription medicines.

Revised guidance documents and new application forms were prepared as part of implementing the outcomes of the review.

The review was conducted as part of implementing TGA Reforms: A blueprint for TGA's future.

Confidentiality of submissions

All submissions have been placed on the TGA website unless marked confidential.

In addition, a list of parties making submissions has been published.