diff --git a/ISO/ISO11615-MedicinalProducts.rdf b/ISO/ISO11615-MedicinalProducts.rdf
index ac41a947..5b6ba70b 100644
--- a/ISO/ISO11615-MedicinalProducts.rdf
+++ b/ISO/ISO11615-MedicinalProducts.rdf
@@ -2774,6 +2774,13 @@ d) the assignment of a unique medicinal product batch identifier (BAID2) to reli
1
+
+
+
+
+ 1
+
+
@@ -2781,6 +2788,20 @@ d) the assignment of a unique medicinal product batch identifier (BAID2) to reli
1
+
+
+
+
+ 1
+
+
+
+
+
+
+ 0
+
+
@@ -2853,15 +2874,15 @@ d) the assignment of a unique medicinal product batch identifier (BAID2) to reli
-
-
- 1
+
+ 0
+
-
-
+
+
1
@@ -2906,8 +2927,8 @@ d) the assignment of a unique medicinal product batch identifier (BAID2) to reli
-
-
+
+
medicinal product
@@ -3189,6 +3210,28 @@ g) therapeutic indication(s) as authorized for the medicinal product.master file holder (organization)
+
+
+
+
+
+
+
+
+
+ additional monitoring indicator
+ medicinal product monitoring indicator
+ ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated medicinal product information, Figure 6 and clause 9.2.2.2.4
+ classifier for medicinal products, specifying whether a given product is subject to additional monitoring
+ If the medicinal product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary.
+
+
+
+
+ ISO/TS 20443:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, clause A.2.4
+ No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.
+
+
@@ -3291,6 +3334,60 @@ g) therapeutic indication(s) as authorized for the medicinal product.If the value for orphan designation status on the medicinal product is non-empty (i.e., the product has such a status), then from a business rule perspective, at least one instance of this classifier should be present.
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+ 1
+
+
+ other product characteristic
+ ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, Figure 11, clause 9.6.2.22
+
+ aspect of a manufactured item, package item, or medical device that describes that product
+ Where applicable for a package item, a manufactured item or a device, other characteristics can be specified. This facility is useful for capturing unusual details not explicitly catered for in the other attributes.
+
+
+
+ ISO/TS 20443:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, clause C.3.15
+ other characteristic
+
+
+
+
+
+
+
+
+
+
+ other product characteristic code
+ ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, Figure 11, clause 9.6.2.22
+ value for an aspect of a manufactured item, package item, or medical device that describes that product, derived from a controlled vocabulary
+
+ ISO/TS 20443:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, clause C.3.15
+ No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.
+
+
@@ -3456,6 +3553,13 @@ g) therapeutic indication(s) as authorized for the medicinal product.0
+
+
+
+
+ 0
+
+
@@ -3470,6 +3574,23 @@ g) therapeutic indication(s) as authorized for the medicinal product.1
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
@@ -3563,6 +3684,25 @@ g) therapeutic indication(s) as authorized for the medicinal product.ISO/TS 20443:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, clause 9.7
+
+
+
+
+
+
+
+
+
+ paediatric use indicator
+ pediatric use indicator
+ ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated medicinal product information, Figure 6 and clause 9.2.2.2.6
+ classifier for medicinal products, specifying whether a given product is authorized for use in children
+
+
+ ISO/TS 20443:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, clause A.2.6
+ No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.
+
+
@@ -3686,7 +3826,7 @@ g) therapeutic indication(s) as authorized for the medicinal product.
-
+
@@ -3743,12 +3883,6 @@ g) therapeutic indication(s) as authorized for the medicinal product.
-
-
-
-
-
-
pharmaceutical product characteristic status
ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, Figure 13, clause 9.8.4.4
classifier for an aspect of a pharmaceutical product that describes that product, such as its onset of action, indicating the state of the characteristic in question
@@ -5356,6 +5490,18 @@ g) therapeutic indication(s) as authorized for the medicinal product.ISO/TS 20443:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, clause 9.6.2.11.2
+
+
+ has special measures
+ ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated medicinal product information, Figure 6 and clause 9.2.2.2.5
+
+ indicates whether a medicinal product is subject to specific special measures
+
+
+ ISO/TS 20443:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, clause A.2.5
+ No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.
+
+
has special precautions for storage