Global: Controlled Vocabulary updated for RPS R2 DSTU by HL7

Health Level 7 international (HL7) has released an updated version of the controlled vocabulary for the "next-generation" electronic submission standard RPS (Regulated Product Submission). The vocabulary concerns the current Release 2 Draft Standard for Trial Use (R2 DSTU).

The updated list contains changes in the vocabulary tables for the "Submitter Category Event" and the "FDA Category Event":

Submitter Category Event:

• For the Category Event "RPS-Sub-Quality", a new entry has been added for Manufacture Information (RPS-Sub-Quality-Manuf)
• For the Category Event "RPS-Sub-Labeling", a new entry "RPS-Sub-Labeling-Final" has been added for the "Final" versions of the Labeling
• Furthermore a new Category Event "Supplement" has been added with code "RPS-Sub-Suppl" and "RPS-Sub-Suppl-PAS" as new entry for "Prior Approval"

FDA Category Event:

• RPS code "RPS-FDA-Ackn-PAS" added for the acknowledgment of a "Prior Approval Supplement" as new entry for the "Acknowledgement" Category Event
• Category Event "RPS-FDA-Info-Req" added to address "Information Request / Advice" with the newly added entry "RPS-FDA-Info-Label" adressing requests/advices regarding "Labeling"
• Category Event "RPS-FDA-Admin" added for "Administrative" reasons with "RPS-FDA-Admin-Appl" addressing the "Applicant"

The new list is available for download in MS Excel format from the HL7wiki RPS website (see link at the bottom of this article). The last update has been published end of July this year (see our related News article).

[Source: HL7wiki]

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