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EU: EMA remote pharmacovigilance inspections guide

2020/11/19  EMA

The necessity to be able to perform pharmacovigilance inspections during crisis situations has been identified as an important issue.

Under crisis situations (e.g. pandemic), on-site inspections may not be possible due to multiple factors such as difficulties and restrictions related to travelling between and within the borders of countries (including travel warnings / restrictions, border controls, transportation difficulties), restrictions to accessing facilities justified by health hazards and local authorities’ recommendations / orders, as well as additional health risks for inspectors and inspectees.

Under such circumstances, remote inspections could replace on-site inspections.

The inspectorate, in agreement with the relevant EMA’s scientific committee, when applicable, should decide on a case by case basis whether a remote inspection will prove sufficient to gain an adequate overview of the functioning of the MAH’s PhV system. Otherwise a postponement of the on-site inspection should be considered.

Remote inspections should follow the guidelines and procedures that already exist for coordinating, preparing and conducting PhV inspections, but should take into consideration the limitations imposed by using a remote process. It is the purpose of this document to outline the specificities of remote PhV inspections by identifying the points that should be considered during the preparation, conduct and reporting of such PhV inspections of marketing authorisation holders (MAHs) with centrally authorised products (CAPs) and national authorised products (NAPs).

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