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The PRAC endorsed the final versions of the above mentioned document that will be published on the
EMA website.
12.2.2. Pharmacovigilance audits
12.2.2.1. Pharmacovigilance Audit Facilitation Group (PAFG)
Standardisation for preparing, performing and reporting pharmacovigilance audits to European
Commission
J Pallos (HU), member of the PAFG, reminded the PRAC how GVP Module IV – Pharmacovigilance
audits requires the development by NCAs of an audit strategy, a high-level document which describes
how the audit activities will be delivered over a period of time. The audit strategy includes a list of
audits that could be performed, outlines areas highlighted for audit, the audit topics as well as the
methods and assumptions (including e.g. risk assessment) on which the audit programme is based.
The PRAC discussed a draft proposal for NCA audit strategies including draft risk ratings for frequency
of audits of pharmacovigilance system activities. The PRAC provided various comments and proposed
that a questionnaire will be circulated to the members to collect structured feedback. Follow-up
discussion will take place at the April 2014 PRAC meeting.
Post-meeting note: a questionnaire was circulated for replies by 1/4/2014.
12.3. Periodic Safety Update Reports & Union Reference Date (EURD) List
12.3.1. Union Reference Date List
12.3.1.1. Consultation on the draft List, version March 2014
The PRAC endorsed the draft revised EURD list version March 2014 reflecting the PRAC comments
impacting DLP and PSUR submission frequencies of the substances / combinations. This also includes
upcoming PSUR single assessment (PSUSA) 26 procedures with allocated PRAC Rapporteur MS and
Rapporteurs’ names in accordance with the principles previously endorsed by the PRAC (see PRAC
Minutes April 2013). The handling of PSURs for substances contained in Nationally Approved Products
(NAPs) is due for discussion at the EMA Management Board on 19-20 March 2014. The PRAC will be
updated accordingly.
Post-meeting note: following the PRAC meeting in March 2014, the updated EURD list was adopted by
the CHMP at its March 2014 meeting and published on the EMA website on 01/04/2014 (see:
Home>Regulatory>Human medicines>Pharmacovigilance>EU reference date and PSUR submission).
12.4. Signal Management
12.4.1. Signal Management
12.4.1.1. Feedback from Signal Management Review Technical (SMART) Working Group
The PRAC heard the monthly update on the work of the SMART Working Group. Feedback received
from the European Generic medicines Association on the implementation of recommendations of the
PRAC for the product information was brought to the attention of the group who will reflect on
26 Referring to procedures with CAP, NAP
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/253432/2014 Page 39/64