The data exclusivity period applicable to pharmaceuticals for
human use is to be extended by the introduction of an 8+2+1 rule to
replace the current 6-year exclusivity period.
The changes are required under EU law and are being introduced as
part of the health pack currently being prioritized by the Polish
Parliament.
This means that:
- For eight years from the date a product first receives marketing authorisation in an EU member state, applicants to register a generic drug may not refer to the information of the original marketing authorisation holder relating to (pre-) clinical testing
- For those eight years plus a further two years, a generic product may not be marketed, even if it has been authorised
- There is additional protection for a further year after that if in the meantime a new indication is registered.
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Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.
The original publication date for this article was 25/10/2010.