Variations to prescription medicines - excluding variations requiring the evaluation of clinical or bioequivalence data

Guidance

Process

• Variations to prescription medicines - excluding variations requiring the evaluation of clinical or bioequivalence data: Process guidance
  How to make variations to existing ARTG entries for prescription medicines

Chemical entities

• Variations to prescription medicines - excluding variations requiring the evaluation of clinical or bioequivalence data; Appendix 1: Variation types - chemical entities
  Outlines types of variations and changes that can be made to chemically derived (non-biological) prescription medicines currently on the ARTG

Biological medicines

• Variations to prescription medicines; Appendix 2: Variation types - biological medicines
  Outlines types of variations and changes that can be made to biological medicines currently on the ARTG

Forms

• Making variations to registered prescription medicines: The Variation e-form is available through the TBS portal.

Templates

The TGA encourages the use of the prescription medicines variations cover letter template, provided below, although it is not mandatory. The template is designed to guide prescription medicine sponsors and regulatory affairs agents, when drafting cover letters, so they meet the expectations of the TGA’s prescription medicines evaluation sections. Using the template may:

• Assist the TGA in readily identifying information relevant to your application. 

• Result in improved evaluation timeframes. 

• Assist in fulfilling the data requirement for the chosen minor variation codes. 

• Reduce the need for request for information (s31) letters relating to missing data.

The TGA welcomes the use of sponsor’s own cover letter templates or formats. However, if you choose to use your own template it is highly recommended that a detailed summary of changes, such as that shown below, be included in the application form to assist the Evaluator. 

• Cover letter template.pdf
• Cover letter template.docx
• Summary of Changes template.pdf
• Summary of Changes template.docx

An example cover letter is included below.

• Example cover letter

Frequently Asked Questions

• Answers to some frequently asked questions on using the prescription medicines Variation e-form.