ePI IG for APAC markets, published by Gravitate Health Project. 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/cander2/aseanepi/ and changes regularly. See the Directory of published versions

Terminology

Controlled terminology is a key part of FHIR since it provides a consistent and standardized method for naming identified terms.

Each Resource contains a set of elements and attributes. Some elements are bound to a controlled terminology. The bindings offer various degrees of flexibility:

• Required: Required to comply with this specific set of terms.
• Extensible: Required to comply with this specific set of terms but additional terms can be added.
• Preferred: Not required but encouraged to use these terms to facilitate international harmonization.
• Example: Not required. Terms are optional and only presented as an example.

The following is a list of controlled terminologies that are preferred because they support international harmonization. Refer to Appendix XX for a complete list in-scope elements and their corresponding terminologies.

Topic	Type of standard	Preferred Standard
Language	International	ISO 639-1 (Two letter)
Country code	International	ISO 3166-1 alpha-2 (Two letter)
Pack Type	EU	EDQM Standard Terms
Pack Material	EU	EDQM Standard Terms
Route of administration	EU	EDQM Standard Terms
Pharmaceutical dose form	EU	EDQM Standard Terms
Combined Pharmaceutical dose form	EU	EDQM Standard Terms
Unit of presentation	EU	EDQM Standard Terms
Units of Measure	International	EDQM Standard Terms
Substance code	US	FDA’s UNII (from Global Substance Registration System (G-SRS))
Substance name	International	WHO INN
Colour	US	FDA SPL Resources
Shape	US	FDA SPL Resources
Flavour	US	FDA SPL Resources