General preparations

ICH recommends providing the following data to represent EDQM terminology for Dose Form and Route of Administration.

The E2B(R3) DTD report populates the following data for Standard Terms for the ICH, EMA, MFDS and NMPA profiles:

Number	Element ID	Element Description
1	G.k.4.r.9.2b	Pharmaceutical Dose Form TermID
2	G.k.4.r.10.2b	Route of Administration TermID
3	G.k.4.r.11.2b	Parent Route of Administration TermID (in case of a parent child/fetus report)

The following elements are not required for Dose Form and Route of Administration as they are optional. Argus populates the following data in order to be consistent with codeSystem and codeSystemVersion implementation for HL7:

Number	Element ID	Element Description
1	G.k.4.r.9.2a	Pharmaceutical Dose Form TermID Version Date/Number
2	G.k.4.r.10.2a	Route of Administration TermID Version Date/Number
3	G.k.4.r.11.2a	Parent Route of Administration TermID Version Date/Number

As part of the Argus release, the following actions touch on factory data:

• Factory data is provided for RoA and DF codelists in Argus to match EDQM Standard list as of July 2021.
• The Routes of Administration codelist in Argus is updated to incorporate the corresponding mapping of E2B(R2) Routes of Administration to EDQM Routes of Administration as published in the ICH User Guide.
• The formulation codelist is updated in Argus to incorporate the corresponding mapping of E2B(R2) Dose Formulations to EDQM Dose Formulations as published on the EAM website.
• Data cleanup for existing factory data for the Routes of Administration and Formulation codelists is done for the terms not used in E2B(R2), eVAERS, eMDR and PMDA reporting by setting the Display attribute as unchecked.