Controls
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.
2. Pharmacovigilance inspections carried out in accordance with Article 123(6) of Regulation (EU) 2019/6 may be performed as on-site or remote inspections.
Pharmacovigilance inspections
1. Marketing authorisation holders shall be prepared for inspections of their pharmacovigilance system and the corresponding pharmacovigilance system master file in accordance with Article 123(6) and Article 126 of Regulation (EU) 2019/6 and shall ensure the same for any person mentioned in Article 26(1).
2. Marketing authorisation holders may be inspected on the site where the pharmacovigilance system master file is located or at any other site of those persons inspected in accordance with paragraph 1. With regard to a third party carrying out pharmacovigilance activities, the site to be inspected may be located within or outside the Union.
3. Marketing authorisation holders shall provide the necessary information requested by the competent authorities or the Agency in accordance with Article 79(6) of Regulation (EU) 2019/6 for on-site or remote inspections.
4. Pharmacovigilance inspections may be either routine inspections or targeted inspections; they may be product-specific or inspections of the general pharmacovigilance system. On the occasion of an inspection, marketing authorisation holders shall:
(a)
present proof that they have personnel, systems and facilities in place to meet their pharmacovigilance obligations and that they are ready for inspection at any time;
(b)
present proof in regard to their contractual arrangements, including a clear description of the roles and responsibilities of third parties to whom pharmacovigilance activities are subcontracted and provisions for their inspection and audit;
(c)
demonstrate that the pharmacovigilance system is in compliance with legislation or relevant pharmacovigilance guidelines;
(d)
provide information on the corrective and preventive action plan management and demonstrate the functionality and the implementation of any change management.
5. Marketing authorisation holders may be required by the competent authority or the Agency to communicate the corrective and preventive action plan in accordance with Article 9(2).
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
It shall apply from 28 January 2022.
