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Regulatory Focus™ > News Articles > Australia Proposing 12 Month Trial Period for OTC Monograph Process

Australia Proposing 12 Month Trial Period for OTC Monograph Process

Posted 19 June 2013 | By Ansis Helmanis

Australia's Therapeutic Goods Administration (TGA) opened a consultation on 18 June 2013 on the implementation of a 12-month trial period of an Over-the-Counter (OTC) New Product N2 application (or Monograph application) route to market.

N2 applications will involve significantly reduced requirements for data assessment and consequently shorter evaluation timelines. Instead of providing full supporting data with the application, sponsors will only need to confirm that the product meets the specified monograph requirements. 

The proposal includes the publication of three OTC monographs covering the most commonly registered OTC products: those containing aspirin, paracetamol and ibuprofen as single active ingredients. Additional monographs will be developed and implemented during the trial period. 

The deadline for comment is 16 July 2013.

TGA: OTC Consultations

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