01 March 2018 EMA/132201/2018 Corporate Stakeholders Department
Agenda – Industry Stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products 23 March 2018, 14:00 -16:00 Chair: Marie-Helene Pinheiro
Item
Preliminary draft agenda
1.
Welcome and introductions
2.
Time
5’
Operational preparedness for Brexit and re-allocation of UK product portfolio in the centralised procedure
15’
Update on EMA-EC Q&As and practical guidance for procedures related 3.
to Brexit for medicinal products for human and veterinary use within
15’
the framework of the centralised procedure Update on EMA Survey to Centrally Authorised Marketing
4.
Authorisation Holders to assess procedural workload resulting from
15’
"Brexit" 5.
Industry update on Brexit preparedness activities
15’
6.
Questions & Answers session
50’
7.
Close of meeting: next steps
5’
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Agenda â Industry stakeholder meeting on Brexit and operation of the
Mar 1, 2018 - the framework of the centralised procedure. 15'. 4. Update on EMA Survey to Centrally Authorised Marketing. Authorisation Holders to assess procedural workload resulting from. "Brexit". 15'. 5. Industry update on Brexit preparedness activities. 15'. 6. Questions & Answers session. 50'. 7. Close of meeting: ...
