Contents
1.Marketing authorisation holders shall be ready for controls in accordance with Article 123 of Regulation (EU) 2019/6 and shall also ensure the following are ready for those controls:
(a)their qualified person responsible for pharmacovigilance in accordance with Article 77(8) of Regulation (EU) 2019/6; and
(b)their representatives responsible for the reporting of adverse events in accordance with Article 14(1)(a) and (l) and Article 77(3) of Regulation (EU) 2019/6;
(c)any other natural or legal person carrying out pharmacovigilance activities in whole or in part, on behalf of or in conjunction with marketing authorisation holders.
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