1naEqka
1naEqka
1naEqka
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
Elements within<br />
the Medicinal<br />
Product Types<br />
element<br />
AP.XX<br />
medicinalproductty<br />
pe<br />
AP.12.MPTs medicinalproducttype Medicinal<br />
Product<br />
Types<br />
Elements within<br />
the Authorised<br />
Product –<br />
Presentation Name<br />
element<br />
AP.13<br />
presentationname<br />
AP.13.1 productname Full<br />
Presentatio<br />
n Name<br />
AP.13.2 productshortname Product<br />
Short<br />
Name<br />
AP.13.3 productgenericname Product<br />
INN/Comm<br />
on Name<br />
M<br />
New element applicable<br />
from June 2014<br />
M* 1.2.12.14.<br />
M<br />
M 1.2.13.1.<br />
M* 1.2.13.2.<br />
M* 1.2.13.3.<br />
EV Web Field label<br />
changed from “Product<br />
Generic Name” to<br />
“Product INN/Common<br />
Name”<br />
AP.13.4 productcompanynam<br />
e<br />
Product<br />
Company<br />
Name<br />
AP.13.5 productstrength Product<br />
Strength<br />
Name<br />
AP.13.6 productform Product<br />
Form Name<br />
AP.13.7 packagedesc Package<br />
Description<br />
Elements within<br />
the Authorised<br />
Pharmaceutical<br />
Forms element<br />
AP.XX<br />
authpharmforms<br />
M* 1.2.13.4.<br />
M* 1.2.13.5.<br />
M* 1.2.13.6.<br />
O 1.2.15.<br />
M<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 24/163