Paragraph 30 Existing data and marketing exclusivity and global marketing authorisationsF1
Sub-paragraph (2) applies in relation to a UK marketing authorisation which, immediately before IP completion day, is part of a global marketing authorisation with one or more EU marketing authorisations or marketing authorisations granted by the competent authority of an EEA state.
Where this sub-paragraph applies, the provisions of regulation 48(5) (definitions for Part 5), in so far as they describe a global marketing authorisation by reference to UK marketing authorisations only, do not affect the periods of data and marketing exclusivity to which the holder of a UK marketing authorisation to which this paragraph applies is entitled immediately before IP completion day.
Annotations
Textual amendments
- F1
Sch. 33A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 7 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 193); 2020 c. 1, Sch. 5 para. 1(1)