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Table 2 - Art 57(2) data element requirements overview for authorised medicinal product<br />
submission<br />
Reference<br />
Code<br />
Schema Field Name<br />
EVWEB<br />
Field<br />
Label<br />
Rules for Art<br />
57(2) submission:<br />
Guidance Link<br />
M - Mandatory<br />
M*- Mandatory<br />
with conditions<br />
O – Optional<br />
Authorised Product<br />
M<br />
elements<br />
M.AP<br />
Authorisedproduct<br />
@ AP..1 (@)operationtype Operation<br />
Type<br />
M<br />
Available operation types<br />
to be used in an XEVPRM<br />
AP.1 localnumber M* 1.2.1.<br />
AP.2 ev_code EV Code M* 1.2.2.<br />
AP.3 newownerid New Owner EMA Use Only 1.2.3.<br />
ID<br />
AP.4 mahcode MAH M 1.2.4.<br />
@ AP.4..1 (@)resolutionmode M<br />
AP.5 qppvcode QPPV M 1.2.5.<br />
AP.6<br />
mflcode<br />
Master File M* 1.2.6.<br />
Location<br />
M* See Chapter 3.I of the<br />
@ AP.6..1 (@)resolutionmode<br />
Detailed guidance:<br />
Extended EudraVigilance<br />
product report message<br />
(XEVPRM) technical<br />
specifications<br />
AP.7 enquiryemail PhV<br />
M 1.2.7.<br />
Enquiry<br />
Email<br />
AP.8 enquiryphone PhV<br />
M 1.2.8.<br />
Enquiry<br />
Phone<br />
AP.9 senderlocalcode Sender O 1.2.9.<br />
Local Code<br />
AP.10 infodateformat O 1.2.10.<br />
AP.11 infodate Info Date M* 1.2.11.<br />
AP.14 comments Comment M* 1.2.16.<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 22/163
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