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account the comments raised. The PRAC was invited to submit further comments by 20/03/2015 and a
revised proposal from the drafting group will be presented at the April 2015 PRAC.
13.2. Pharmacovigilance programme and revised implementation
governance
At the organisational matters teleconference held on 26 March 2015, the EMA Secretariat presented
the Pharmacovigilance Programme Update (third edition from March 2015).
13.3. Product Information: revision of the review process for initial
marketing authorisation
At the organisational matters teleconference held on 26 March 2015, the EMA Secretariat presented
the revision of the product information review process for initial marketing authorisation applications.
Earlier identification of issues, greater consistency and a simplified process were the aim of this review.
These process changes will be reflected in the relevant SOP/WIN 26 and guidance documents. Training
for the network is planned in March 2015 to present these changes and the implementation plan. The
revised process has been presented to all the relevant committees (CHMP, PRAC and CAT) in March
2015 and it will start being implemented for initial marketing authorisation applications in April 2015.
13.4. Type II variations: revised procedural timetables
The EMA Secretariat presented some changes to the monthly-start type II variations timetables. As
some clarifications were requested by the PRAC, this proposal was further discussed at the
organisational matters teleconference held on 26 March 2015. It was agreed to further discuss this
proposal at the April 2015 PRAC.
26 Standard operating procedure(s)/work Instructions
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/257790/2015 Page 61/89