Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

## ValueSet: PQCMC Name Part Terminology

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology | Version: 2.0.0
Standards status: Trial-use | Maturity Level: 2 | Computable Name: PqcmcNamePartTerminology
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.48.14

Terminology used to qualify the information pertaining to Name Part data in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

References

- Batch Formula Drug Product Identification
- Drug Product Description
- Drug Product Handle
- Drug Product Impurities

### Logical Definition (CLD)

- Include these codes as defined in `http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2`

  Code | Display | Definition
  CON | container name | **Description:** This refers to the container if present in the medicinal product name. EXAMPLES: * For Optaflu suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell culture) (2007/2008 season): pre-filled syringe
  DEV | device name | **Description:** This refers to the qualifiers in the name for devices and is at the moment mainly applicable to insulins and inhalation products. EXAMPLES: * For the medicinal product Actrapid FlexPen 100 IU/ml Solution for injection Subcutaneous use: FlexPen.
  FLAV | FlavorName | **Description:** This refers to a flavor of the medicinal product if present in the medicinal product name. **Examples:** * For 'CoughCure Linctus Orange Flavor', the flavor part is "Orange" * For 'Wonderdrug Syrup Cherry Flavor', the flavor part is "Cherry"
  FORMUL | FormulationPartName | **Description:** This refers to the formulation of the medicinal product if present in the medicinal product name. **Examples:** * For 'SpecialMed Sugar Free Cough Syrup', the formulation name part is "Sugar Free" * For 'QuickCure Gluten-free Bulk Fibre', the formulation name part is "gluten-free"
  FRM | form name | **Description:** This refers to the pharmaceutical form/ if present in the medicinal product name. EXAMPLES: * For Agenerase 50 mg soft capsules: Soft Capsules * For Ludiomil 25mg-Filmtabletten: Filmtabletten * For Optaflu suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell culture) (2007/2008 season): suspension for injection
  INV | invented name | **Description:** This refers to the product name without the trademark or the name of the marketing authorization holder or any other descriptor reflected in the product name and, if appropriate, whether it is intended e.g. for babies, children or adults. EXAMPLES: * Agenerase * Optaflu * Ludiomil
  POPUL | TargetPopulationName | **Description:** This refers to the target population for the medicinal product if present in the medicinal product name **Examples:** * For 'Broncho-Drug 3.5 mg-capsules for children', the target population part is "children" * For 'Adult Chesty Cough Syrup', the target population part is "adult"
  SCI | scientific name | **Description:** This refers to the product common or scientific name without the trademark or the name of the marketing authorization holder or any other descriptor reflected in the product name. EXAMPLES: * For Agenerase: N/A * For Optaflu: Influenza vaccine (surface antigen, inactivated, prepared in cell culture) (2007/2008 season) * For Ludiomil: N/A
  STR | strength name | **Description:** This refers to the strength if present in the medicinal product name. The use of decimal points should be accommodated if required. EXAMPLES: * For Agenerase 50 mg soft capsules: 50mg * For Ludiomil 25mg-Filmtabletten: 25 mg * For Optaflu suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell culture) (2007/2008 season): N/A
  TIME | TimeOrPeriodName | **Description:** This refers to a time or time period that may be specified in the text of the medicinal product name **Example:** * For an influenza vaccine 'Drug-FLU season 2008/2009', the time/period part is "2008/2009 season"
  TMK | trademark name | **Description:** This refers to trademark/company element if present in the medicinal product name. EXAMPLES: * for Insulin Human Winthrop Comb 15: Winthrop
  USE | intended use name | **Description:** This refers to the intended use if present in the medicinal product name without the trademark or the name of the marketing authorization holder or any other descriptor reflected in the product name. **Examples:** * For 'Drug-BI Caplets - Heartburn Relief', the intended use part is: "Heartburn Relief" * For 'Medicine Honey Syrup for Soothing Coughs' the intended use part is "Soothing Coughs"

### Expansion

Expansion performed internally based on codesystem EntityNamePartQualifierR2 v3.0.0 (CodeSystem)

This value set contains 12 concepts

Code | System | Display (en-US) | Definition
CON | http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | container name | Description: This refers to the container if present in the medicinal product name. EXAMPLES: For Optaflu suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell culture) (2007/2008 season): pre-filled syringe
DEV | http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | device name | Description: This refers to the qualifiers in the name for devices and is at the moment mainly applicable to insulins and inhalation products. EXAMPLES: For the medicinal product Actrapid FlexPen 100 IU/ml Solution for injection Subcutaneous use: FlexPen.
FLAV | http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | FlavorName | Description: This refers to a flavor of the medicinal product if present in the medicinal product name. Examples: For 'CoughCure Linctus Orange Flavor', the flavor part is "Orange" For 'Wonderdrug Syrup Cherry Flavor', the flavor part is "Cherry"
FORMUL | http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | FormulationPartName | Description: This refers to the formulation of the medicinal product if present in the medicinal product name. Examples: For 'SpecialMed Sugar Free Cough Syrup', the formulation name part is "Sugar Free" For 'QuickCure Gluten-free Bulk Fibre', the formulation name part is "gluten-free"
FRM | http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | form name | Description: This refers to the pharmaceutical form/ if present in the medicinal product name. EXAMPLES: For Agenerase 50 mg soft capsules: Soft Capsules For Ludiomil 25mg-Filmtabletten: Filmtabletten For Optaflu suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell culture) (2007/2008 season): suspension for injection
INV | http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | invented name | Description: This refers to the product name without the trademark or the name of the marketing authorization holder or any other descriptor reflected in the product name and, if appropriate, whether it is intended e.g. for babies, children or adults. EXAMPLES: Agenerase Optaflu Ludiomil
POPUL | http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | TargetPopulationName | Description: This refers to the target population for the medicinal product if present in the medicinal product name Examples: For 'Broncho-Drug 3.5 mg-capsules for children', the target population part is "children" For 'Adult Chesty Cough Syrup', the target population part is "adult"
SCI | http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | scientific name | Description: This refers to the product common or scientific name without the trademark or the name of the marketing authorization holder or any other descriptor reflected in the product name. EXAMPLES: For Agenerase: N/A For Optaflu: Influenza vaccine (surface antigen, inactivated, prepared in cell culture) (2007/2008 season) For Ludiomil: N/A
STR | http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | strength name | Description: This refers to the strength if present in the medicinal product name. The use of decimal points should be accommodated if required. EXAMPLES: For Agenerase 50 mg soft capsules: 50mg For Ludiomil 25mg-Filmtabletten: 25 mg For Optaflu suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell culture) (2007/2008 season): N/A
TIME | http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | TimeOrPeriodName | Description: This refers to a time or time period that may be specified in the text of the medicinal product name Example: For an influenza vaccine 'Drug-FLU season 2008/2009', the time/period part is "2008/2009 season"
TMK | http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | trademark name | Description: This refers to trademark/company element if present in the medicinal product name. EXAMPLES: for Insulin Human Winthrop Comb 15: Winthrop
USE | http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | intended use name | Description: This refers to the intended use if present in the medicinal product name without the trademark or the name of the marketing authorization holder or any other descriptor reflected in the product name. Examples: For 'Drug-BI Caplets - Heartburn Relief', the intended use part is: "Heartburn Relief" For 'Medicine Honey Syrup for Soothing Coughs' the intended use part is "Soothing Coughs"

Explanation of the columns that may appear on this page:

Level | A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies
System | The source of the definition of the code (when the value set draws in codes defined elsewhere)
Code | The code (used as the code in the resource instance)
Display | The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application
Definition | An explanation of the meaning of the concept
Comments | Additional notes about how to use the code