The study's purpose is stated as follows:
The contracted study shall evaluate whether a new European SPC title, with the current or broader scope within the field of pharmaceutical and plant protection products, with improved provisions, is required to meet the requirements of current and expected innovative market developments in the EU.Details of the tender can be found here.
With this primary purpose, the study shall evaluate the current SPC framework in terms of its legal efficiency in meeting its stated objectives given the development of directly affected and related product markets.
It shall also suggest whether the existing SPC rules need to be recalibrated given identified limitations.
The results could serve as a basis for an impact assessment for a future proposal by the Commission to recalibrate the existing EU SPC rules.
1 comment:
Please be aware that as EU law fully applies until the UK actually leaves -UK firms etc are fully entitled to bid.
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