Poland: extended data exclusivity period for pharmaceuticals

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.