This section has no associated Explanatory Memorandum
6. The references to “the Eudravigilance database” in regulation 188(1)(a) and (d) (reporting obligations on holders) shall be read as follows—U.K.
(a)in regulation 188(1)(a) and (d) in relation to serious adverse reactions that occur within the EEA, as a reference to the competent authority of each EEA State in whose territory the reaction occurred; and
(b)in regulation 188(1)(a) and (d) in relation to serious adverse reactions that occur within a third country, as a reference to—
(i)the EMA, and
(ii)the relevant competent authorities insofar as each of those competent authorities has requested that serious adverse reaction reports for third countries are submitted to it.