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Pharmaceutical products: "each Party shall protect such data against disclosure"

February 17 2014 at 3:09 PM
As in: Paroxetine 329, Zyprexa docs, et al? 


Response to TPPs 'wide-ranging effects on medicines...who may produce drugs or transmit information'

https://wikileaks.org/tpp/#QQE20

"...1. Where a Party requires, as a condition of marketing, regulatory or sanitary approval for pharmaceutical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, that Party shall protect such data against unfair commercial use. In addition, each Party shall protect such data against disclosure, except where necessary to protect the public or unless steps are taken to ensure that the data is protected against unfair commercial use.

  1. Each Party may provide that the protection of data under paragraph 1, inter alia:

    1. is limited to undisclosed test or other data, the origination of which involves a considerable effort;

    2. is limited to pharmaceutical products that do not contain a new chemical entity that has been previously approved for marketing in the Party;

    3. is limited to pharmaceutical products which utilize a new chemical entity;

    4. is available only once per pharmaceutical product;

    5. is not available for new uses or indications, new dosage forms or methods of making a pharmaceutical product;

    6. is limited to a period of time as determined by the Party; or

    7. may be waived to facilitate the marketing, regulatory or sanitary approval of a pharmaceutical product that is the subject of a voluntary or compulsory license, or a licence otherwise issued pursuant to the TRIPS Agreement..."




 
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