6 Generate E2B(R3) reports for EMA, MFDS and NMPA

Follow these steps to create or process cases using EDQM terminology for Routes of Administration and Dose Form:

1. Book-in a case with the information received according to source documents.
2. Verify if Dose Formulation and Routes of Administration is part of the EDQM Standard List.
3. Save the case and ensure all the mandatory data required for E2B(R3) submission are entered.
4. Perform Auto-scheduling so that the system schedules an E2B report to the agency using 3.0 DTD Profile.
5. Click the Draft link to preview the report in XML view.

The <G.k.4.r.9.2b> element is populated with the value indicating the corresponding EDQM TERM ID associated with Dose Formulation.

The <G.k.4.r.10.2b> and <G.k.4.r.11.2b> elements are populated with the values that indicate the corresponding EDQM TERM ID associated with Routes of Administration.

The EDQM details data are embedded within the drug block pertaining to the product as below.

<!--G.k.4.r.10.2a: Route of Administration TermID Version Date / Number-->
<!--G.k.4.r.10.2b: Route of Administration TermID-->
<routeCode code="ROA-20001000" codeSystem="0.4.0.127.0.16.1.1.2.6" codeSystemVersion="1">
	<originalText>Auricular use</originalText>
</routeCode>
<consumable typeCode="CSM">
	<instanceOfKind classCode="INST">
		<kindOfProduct classCode="MMAT" determinerCode="KIND">
			<!--G.k.4.r.9.1: Pharmaceutical form (Dosage form)-->
			<!--G.k.4.r.9.2a: Pharmaceutical Dose Form TermID Version Date / Number -->
			<!--G.k.4.r.9.2b: Pharmaceutical Dose Form TermID -->
			<formCode code="BDF-0051" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemVersion="2">
				<originalText>Capsule</originalText>
			</formCode>
		</kindOfProduct>
	</instanceOfKind>
</consumable>
<inboundRelationship typeCode="REFR">
	<observation moodCode="EVN" classCode="OBS">
		<code code="28" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" />
		<!--G.k.4.r.11.2a: Parent Route of Administration TermID Version Date / 
       Number-->
		<!--G.k.4.r.11.2b: Parent Route of Administration TermID-->
		<value xsi:type="CE" code="ROA-20004000" 
       codeSystem="0.4.0.127.0.16.1.1.2.6" codeSystemVersion="1">
			<originalText>Dental use</originalText>
		</value>
	</observation>
</inboundRelationship>