1naEqka
1naEqka
1naEqka
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@ PP.AR.1..1 (@)resolutionmode M See Chapter 3.I of the<br />
Detailed guidance:<br />
Extended EudraVigilance<br />
product report message<br />
(XEVPRM) technical<br />
specifications<br />
M<br />
Elements within<br />
the Authorised<br />
Product – ATC<br />
element<br />
AP.ATC productatc<br />
AP.ATC.1 atccode ATC Code M 1.2.18.<br />
@<br />
AP.ATC.1..1<br />
(@)resolutionmode M See Chapter 3.I of the<br />
Detailed guidance:<br />
Extended EudraVigilance<br />
product report message<br />
(XEVPRM) technical<br />
specifications<br />
M*<br />
The Pharmaceutical<br />
Product – Medical<br />
Device elements<br />
PP.MD.1 medicaldevicecode Medical M 1.2.17.12.<br />
Device<br />
M<br />
The Authorised<br />
Product<br />
– Printed Product<br />
Information<br />
Attachment<br />
element<br />
AP.PPI<br />
ppiattachment<br />
AP.PPI.1 attachmentcode Product M 1.2.21.1.<br />
Attachment<br />
@<br />
AP.PPI.1..1<br />
(@)resolutionmode M See Chapter 3.I of the<br />
Detailed guidance:<br />
Extended EudraVigilance<br />
product report message<br />
(XEVPRM) technical<br />
specifications<br />
AP.PPI.2 validitydeclaration Validity<br />
Declaration<br />
M* 1.2.21.2.<br />
Detailed guidance on the electronic submission of information on medicinal products<br />
for human use by marketing authorisation holders to the European Medicines Agency in<br />
accordance with Article 57(2) of Regulation (EC) No. 726/2004<br />
EMA/135580/2012 Page 30/163