Data Exclusivity Hk.
Vietnam provides a 5 data exclusivity period which commences from the date on which a product licence is granted. For the 2012 2014 the focus of our directions will be on enhancing drug accessibility drug safety communications and drug education. The critical paths and end points for key initiatives were also shared.
In the european union data exclusivity is provided per the provisions of article 14 11 of regulation 726 2004 which applies to products submitted for approval via the centralized authorization procedure cap after november 20 2005. The hong kong association of the. Under the pharmaceutical affairs law the japanese regulatory authority re. More far reaching extension of patent term provisions to come. Vietnam provides a 5 data exclusivity period which commences from the date on which a product licence is granted.
Data exclusivity is the period during which no generic drug application can take place. The hong kong association of the. Such an agreement is not legally binding unless it is either executed as a deed or is supported by consideration e g. Data exclusivity is a separate and additional provision to patent protection for the originator medicine. For the 2012 2014 the focus of our directions will be on enhancing drug accessibility drug safety communications and drug education. Under the pharmaceutical affairs law the japanese regulatory authority re. The critical paths and end points for key initiatives were also shared. It provides a form of market exclusivity outside that provided by patent rights. Mutual exclusivity obligations or the payment of consideration. With data exclusivity there can be neither disclosure of regulatory data to a competitor nor regulatory reliance upon the data.
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There are currently no provisions in hong kong for obtaining an extension of term of a patent or for the protection of data submitted to a regulatory authority.
Data exclusivity in european union and european economic area. The critical paths and end points for key initiatives were also shared. Data exclusivity in european union and european economic area. Test data exclusivity refers to protection of clinical trial data required to be submitted to a regulatory agency to prove safety and efficacy of a new drug and prevention of generic drug manufacturers from relying on this data in their own applications. Hong kong law does not imply exclusivity in negotiations and therefore parties seeking exclusivity would normally enter into an exclusivity agreement. With data exclusivity there can be neither disclosure of regulatory data to a competitor nor regulatory reliance upon the data. Data exclusivity refers to a period of protection for data provided by an innovator company to a regulatory agency to prove the safety and efficacy of a new pharmaceutical product. Under the pharmaceutical affairs law the japanese regulatory authority re. For the 2012 2014 the focus of our directions will be on enhancing drug accessibility drug safety communications and drug education. It provides a form of market exclusivity outside that provided by patent rights. Mutual exclusivity obligations or the payment of consideration.