WC500169468

Background
The CHMP) adopted a negative opinion in January 2014 recommending the refusal of the marketing
authorisation for the medicinal product Nerventra, intended for the treatment of multiple sclerosis.
The MAH requested a re-examination of the CHMP opinion and CHMP asked PRAC advice concerning
aspects relating to the proposed risk management plan.
Summary of advice
The PRAC agreed on the main elements of the risk minimisation programme expected to be put in
place should the CHMP reach a positive opinion on its marketing authorisation. However the PRAC was
not convinced about the effectiveness of the company’s proposed pregnancy prevention measures.
Post-meeting note: after considering the grounds for this request, the CHMP re-examined the initial
opinion, and confirmed the refusal of the marketing authorisation on 22 May 2014. See
EMA/311892/2014.
11. Other Safety issues for discussion requested by the
Member States
None
12. Organisational, regulatory and methodological matters
12.1. Mandate and organisation of the PRAC
12.1.1. PRAC Work Programme
Draft PRAC Work Programme 2014-2015
PRAC discussed a consolidated list of key contributors for some areas of the work programme who will
be working in defining the deliverables for each item, to be completed by the end of 2014/15. Further
discussion will also take place at the informal meeting of the PRACmeeting under the Greek presidency
of the EU. Feedback is planned for the June 2014 meeting of the PRAC.
12.2. Pharmacovigilance audits and inspections
None
12.3. Periodic Safety Update Reports & Union Reference Date (EURD) List
12.3.1. Union Reference Date List
Consultation on the draft list, version May 2014
The PRAC endorsed the draft revised EURD list version May 2014 reflecting the PRAC comments
impacting DLP and PSUR submission frequencies of the substances/combinations. The PRAC endorsed
the newly allocated Rapporteurs for upcoming PSUSAs in accordance with the principles previously
endorsed by the PRAC (see PRAC Minutes April 2013).
Post-meeting note: following the PRAC meeting in May 2014, the updated EURD list was adopted by
the CHMP at its May 2014 meeting and published on the EMA website on 28/05/2014 (see:
Home>Regulatory>Human medicines>Pharmacovigilance>EU reference date and PSUR submission).
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/324055/2014 Page 47/73