7 Generate E2B(R3) reports for non-standard terms

Follow these steps to create and process cases using non-standard terms. These cases include terms that are not part of the EDQM terminology for Routes of Administration and Dose Form:

1. Book-in a case with the information received as per Source documents.
2. Verify that Dose Formulation and Routes of Administration are not part of the EDQM Standard List.
3. Save the case and ensure that 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.9.1> element is populated with free text associated with Dose Formulation.

The <G.k.4.r.10.1> and <G.k.4.r.11.1> elements are populated with free text 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>
	<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>
				<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">
			<originalText>Dental use</originalText>
		</value>
	</observation>
</inboundRelationship>

Note:

If you already use a custom profile for reporting to EMA or MFDS, then you can recreate a new custom profile based on the respective template if you want to use updated mappings or other EDQM related settings. You might encounter issues during report generation if you try to re-use an existing profile without all changes set in the Out-of-the-box (OOTB) profile.

Note:

E2B(R2), eVAERS, PMDAR3 do not populate EDQM TERM ID, but they populate data according to the existing logic.