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1. Introduction
1.1. Welcome and declarations of interest of members, alternates and
experts
The Chairperson opened the meeting, welcoming all participants to the 10-13 June 2014 meeting of
the PRAC.
Based on the declarations of interest submitted by the Committee members, alternates and experts
and based on the topics in the agenda of the current meeting, the Committee Secretariat announced
the restricted involvement of some Committee members for the related upcoming discussions; in
accordance with the Agency’s policy on the handling of conflicts of interests, participants in this
meeting were asked to declare any changes, omissions or errors to the already declared interests on
the matters for discussion (see Annex II). No new or additional conflicts were declared.
Discussions, deliberations and voting took place in full respect of the restricted involvement of
Committee members and experts in line with the relevant provisions of the Rules of Procedure.
All decisions taken at this meeting were made in the presence of a quorum of members (i.e. 24 or
more members were present in the room). All decisions, recommendations and advice were agreed
unanimously, unless otherwise specified.
The PRAC noted that Alexandra Martinovic had stepped down as alternate for Austria and thanked her
for her contribution to the work of the PRAC.
1.2. Adoption of agenda of the meeting on 10-13 June 2014
The agenda was adopted with some modifications, upon request from the members of the Committee
and as proposed by the EMA secretariat.
1.3. Minutes of the previous PRAC meeting on 5-8 May 2014
The minutes were adopted with some amendments received during the consultation phase and will be
published on the EMA website.
Post-meeting note: the PRAC minutes of the meeting held on 5-8 May 2014 EMA/PRAC/324055/2014
were published on the EMA website on 1 July 2014.
2. EU Referral Procedures for Safety Reasons: Urgent EU
Procedures
2.1. Newly triggered procedures
None
2.2. Ongoing Procedures
2.2.1. Methadone medicinal products for oral use containing povidone (NAP)
Review of the benefit-risk balance following notification by Norway of a referral under Article
107i of Directive 2001/83/EC, based on pharmacovigilance data
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/438418/2014 Page 11/75