Download (XEVMPD) Bulk Update Manager

9. Quick reference guide............................................................................ 44
9.1. Quick Guide ....................................................................................................... 44
9.2. FAQs................................................................................................................. 44
9.2.1. User Access .................................................................................................... 44
9.2.2. Filters ............................................................................................................ 44
9.2.3. Requesting an Product set ................................................................................ 45
9.2.4. Monitoring an request to create a product set ..................................................... 45
9.2.5. Bulk Update Operations .................................................................................... 45
10. Annex .................................................................................................. 46
10.1. Step by Step Guide – Change of "QPPV" .............................................................. 46
10.2. Step by Step Guide – Change of "MAH" and "MedDRA version"............................... 50
10.3. Step by Step Guide – Addition of an "Authorised Pharmaceutical Form" and change of
the "Administrable Pharmaceutical Form" ..................................................................... 56
eXtended EudraVigilance Medicinal
Product Dictionary (XEVMPD) Bulk
Update Manager
EMA/623491/2014
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