Updated requirements for pharmacovigilance contact person at national level in EU (LCPPV)

Written by Caffeinate

on 5 September 2021

It is difficult to get clear information about the requirements for local contact persons for pharmacovigilance in the EU as these are determined by the individual member states and are not harmonized.

In October 2020 the EMA conducted a survey of all member states to clarify the national requirements which help in the assessment of what is needed even though there are still many unanswered questions where interaction with the individual agency is the only way to determine what is required. For example both Spain and Portugal require a local contact person for pharmacovigilance according to the EU survey but if a product is approved in the EU and not yet put on the market Spain does not require a local contact person for pharmacovigilance – but Portugal does. So the survey does give some guidance but you need to get expert assistance to determine the exact requirements as it is expensive to establish this local representation

You can download the EMA survey here.

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