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Copyright and Registered Trademark Uses

IG © 2025+ HL7 International. Package hl7.fhir.uv.rtq-ig#0.1.0 based on FHIR 5.0.0. Generated 2025-12-09 Links: Table of Contents | QA Report ( src )
hl7.fhir.us.hai: Healthcare Associated Infection Implementation Guide ®© HL7 | CC0 ( src )
Response to Regulatory Questions (RTQ), published by HL7 International. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/rtq-ig/ and changes regularly. See the Directory of published versions ( src )
The (c) symbol should NOT be included in this string. It will be added by software when rendering the notation. Full details about licensing, restrictions, warrantees, etc. goes in the more general 'copyright' element. ( src )

External References

Type	Reference	Content
web	github.com	Response to Regulatory Questions (RTQ), published by HL7 International. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/rtq-ig/ and changes regularly. See the Directory of published versions
web	www.sciencedirect.com	This aligns with the broader strategy defined in the APIX Implementation Guide : moving towards the "Real-time algorithmic exchange" envisioned in the 2023 International Journal of Pharmaceutics framework (click to read) .
web	www.iso20022.org	Just as ISO 20022 harmonized global payments, RTQ + APIX harmonizes the regulatory dialogue—standardizing the content (RTQ) and the exchange (APIX) to unlock sub-second decision making.
web	www.ema.europa.eu	See EMA Fee Guidance for payment confirmation requirements.
web	www.ich.org	Reference: ICH Q1A(R2)
web	www.who.int	Note: Confirm coverage for Zone IVb (30°C/75% RH) per WHO TRS 1010
web	www.ich.org	Threshold: >0.10% per ICH Q3B(R2)
web	www.ema.europa.eu	See EMA Fee Guidance for payment confirmation requirements.

Type

Reference

Content

web

github.com

Response to Regulatory Questions (RTQ), published by HL7 International. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/rtq-ig/ and changes regularly. See the Directory of published versions

web

www.sciencedirect.com

This aligns with the broader strategy defined in the APIX Implementation Guide : moving towards the "Real-time algorithmic exchange" envisioned in the 2023 International Journal of Pharmaceutics framework (click to read) .

web

www.iso20022.org

Just as ISO 20022 harmonized global payments, RTQ + APIX harmonizes the regulatory dialogue—standardizing the content (RTQ) and the exchange (APIX) to unlock sub-second decision making.

web

www.ema.europa.eu

See EMA Fee Guidance for payment confirmation requirements.

web

www.ich.org

Reference: ICH Q1A(R2)

web

www.who.int

Note: Confirm coverage for Zone IVb (30°C/75% RH) per WHO TRS 1010

web

www.ich.org

Threshold: >0.10% per ICH Q3B(R2)

web

www.ema.europa.eu

See EMA Fee Guidance for payment confirmation requirements.

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