This note follows from GNL 24, which sets out the basics of data and market exclusivity and how long it lasts. It explains the additional exclusivity periods potentially available for well-established substances, combinations and where there is a change of legal classification.

Note: the regulations discussed in this note may be subject to change after the expiry of the transition period that follows the UK’s exit from the EU on 31 January 2020. The transition period currently expires on 31 December 2020, but may be extended.

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