MIL-OSI Australia: Data protection scheme for assessed listed medicines


Source: Australian Department of Health

The TGA has implemented a Data Protection Scheme for Assessed listed medicines. This Scheme was developed in response to Recommendation 50 of the Medicines and Medical Devices Regulation (MMDR) review and is enabled under section 26AF of the Therapeutic Goods Act 1989.

The purpose of the Scheme is to:

  • Incentivise innovation by protecting the results of investment in the development of new works and technology.
  • Prevent competitors seeking market authorisation of generic forms of an L(A) medicine by preventing competitors from relying on clinical trials that were generated and used by the sponsor of the originator medicine to obtain market authorisation.
  • Encourage further research and development activities by preventing others from capitalising on a sponsor’s investment and innovation.

Guidance document

This guidance describes:

  • How the Data Protection Scheme for assessed listed medicines works
  • How to submit an application and make a restricted information certification

List of assessed listed medicines with data protection

There is no information for inclusion in this table. The text is an example of what information might be added in these fields

Medicine Name and AUST L(A) Active Ingredient(s) New intermediate indication Unique Clinical Trial number/UTN Journal article Protection expiry

Medicine Name

AUST L(A) xxxxxx

AAN of active ingredient

Novel intermediate indication

CTN: ACTRN12345678901234

UTN: U1234-5678-9012

N/A if not published or

Clinical study report ABC012021: Evaluation of the efficacy of X (containing 20mg Z) for alleviation of Y. Author.