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TRACKING AND MONITORING WEB SERVICE DEFINITIONS DOCUMENT DOCUMENT

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TRACKING AND MONITORING WEB SERVICE DEFINITIONS DOCUMENT DOCUMENT

Revision Number: 1.51

Compatible with ÜTS Version 7.6.x.

(2)

1.0.13 16/02/2016 Name, parameters taken and changed notifications of the return data structure were updated.

Eren ŞENELMİŞ

14/03/2016 The deficiencies in the parameters taken by the notifications were eliminated.

Packet notifications and other services related to the packet were added.

Eren ŞENELMİŞ

1.0.20 01/07/2016 REST addresses were updated. Ahmet Çağrı ŞİMŞEK

Murat NARMANLI 12/10/2016 Services, service parameters and service messages were

updated.

Kerim ÖZTÜRK

08/11/2016 Missing inquiry services were added. Kerim ÖZTÜRK

13/12/2016 The Barcode Agency Field was removed from Inquiries.

Missing inquiry services were added.

Ahmet Çağrı Şimşek

1.0.26 20/12/2016 Medula – ÜTS integration services were added. Missing inquiry services and messages were added.

Kerim ÖZTÜRK

1.0.27 27/12/2016 All services related to the packet were deleted. Kerim ÖZTÜRK

1.0.28 09/02/2017 System packet services were added. Emre ÇİLESİZ

1.0.30 15/02/2017 Notification services for purchase/return receipts done with individual product information and unique device identifier were added. The inquiry request and response fields were updated.

Nurseda ÖZDEMİR

1.0.31 23/03/2017 Sample request structures for each notification and inquiry were added. The request and response fields for notifications made with unique device identifier were added.

The temporary notification name change was updated as

"borrowed". Medula – ÜTS integration services were removed.

Kerim ÖZTÜRK

1.0.33 24/04/2017 Borrowed return, cancellation, borrowed retrieval notification services were added, the individual product and notifications that went out of the system were added.

Kerim ÖZTÜRK

1.0.34 13/06/2017 The data fields that changed as a result of VEDOP inquiries being done instead of MERSIS for Delivery Notifications to places Undesignated on ÜTS and deliver packet notifications for place Undesignated on ÜTS.

Ahmet Çağrı Şimşek

1.0.35 21/09/17 The UDI and unique device identifier fields explanations were corrected, the Delivery to Consumer and Usage

Ahmet Çağrı Şimşek

(3)

1.0.36 18/10/2017 Data fields were added as needed for different companies to make Retrieve from Consumer Notifications, error messages were added and updates were made in some error messages.

Kerim ÖZTÜRK

1.0.37 23.11.2017 1) A field was added for the "Destroy/Disposal Document Number" required in Destroy/Disposal Notification.

2) The "Company Number" (KUN) field that is required in Borrowed Return Notification was removed.

3) Where "Delivery to Consumer Cancellation Notification"

was written has been updated as “Cancel Delivery to Consumer Notification".

4) The required date field "Delivery to Consumer Date" for Delivery to Consumer Notification was added,

The date field "Use Date" required for Usage Notification was added,

The date field "Loan Out Date" required for Loan Out Notification was added,

The date field "Provision for Temporary Use Date" required for Providing for Temporary Usage Notification was added, The date field "Date of Removal from Patient Body" required for Removal from Patient Body Notification was added, The common JSON name for these is "GIT" (Actual Transaction Date).

5) The "Voluntary Tracking Scope" (GTK) which is not required has been added to Production and Import Notifications.

6) "Field Company Name" (AKU), "Brand Model Label Name" (MME) has been added to the pending individual product inquiries. "Sender Company Name" (GKU), "Brand Model Label Name" (MME) has been added to the individual product inquiries to be accepted. "Brand Model Label Name" (MME) has been added to the individual product inquiries. "Notifier Company Name" (BKU), "Other Company Name" (DKU) and "Brand Model Label Name" (MME) has been added to notification inquiries. 4. The "Actual Transaction Date" (GIT) added in article 4 was added to the necessary inquiries. "Manufacturer Importer Company No"

(UIK) was added to the necessary inquiries.

7) The warning messages added to the system were added to the document.

Kerim Öztürk

1.0.51 18/12/2017 Product Inquiry service was added. Akif BOYNUEĞRİ

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1.3 TERMS AND ABBREVIATIONS ...14

2 THE GENERAL STRUCTURE OF WEB SERVICES ...15

2.1 INTEGRATION OF THE ÜTS WITH OTHER INFORMATION SYSTEMS ...15

3 WEB SERVICES...16

3.1 ACTION NOTIFICATION SERVICES ...16

3.1.1.1 Production Notification Service Address ... 16

3.1.1.2 Production Notification Data Fields ... 16

3.1.1.3 Production Notification Sample Request ... 18

3.1.2.1 Import Notification Service Address ... 19

3.1.2.2 Import Notification Data Fields ... 20

3.1.2.3 Import Notification Sample Request ... 22

3.1.3.1 Delivery Notification Service Address ... 24

3.1.3.2 Delivery Notification Sample Request ... 25

3.1.3.3 Delivery Notification Service Address with Unique Device Identifier Information ... 26

3.1.3.4 Delivery Notification Data Fields with Unique Device Identifier Information ... 26

3.1.3.5 Delivery Notification with Unique Device Identifier Information Sample Request ... 26

3.1.4.1 Receive notification Service Address ... 27

3.1.4.2 Receive notification Data Fields ... 27

3.1.4.3 Receive notification Sample Request ... 29

3.1.4.4 Receive notification Service Address with Unique Device Identifier Information ... 29

3.1.4.5 Receive notification Data Fields with Unique Device Identifier Information ... 29

3.1.4.6 Receive notification with Unique Device Identifier Information Sample Request ... 30

3.1.5.1 Delivery Notification to a Place Undesignated on ÜTS Service Address ... 31

3.1.5.2 Delivery Notification to a Place Undesignated on ÜTS Data Fields ... 31

3.1.5.3 Delivery Notification to a Place Undesignated on ÜTS Sample Request ... 32

3.1.5.4 Delivery Notification with Unique Device Identifier to a Place Undesignated on ÜTS Service Address .... 32

3.1.5.5 Delivery Notification with Unique Device Identifier to a Place Undesignated on ÜTS Data Fields ... 32

3.1.5.6 Delivery Notification with Unique Device Identifier to a Place Undesignated on ÜTS Sample Request .... 34

3.1.1 PRODUCTION NOTIFICATION ...16

3.1.2 IMPORT NOTIFICATION ...19

3.1.3 DELIVERY NOTIFICATION ...24

3.1.4 RECEIVE NOTIFICATION ...27

3.1.5 DELIVERY NOTIFICATION TO A PLACE UNDESIGNATED ON ÜTS ...31

ÜTS

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3.1.6.1 Retrieve from undesignated place on ÜTS Notification Service Address ... 34

3.1.6.2 Retrieve from undesignated place on ÜTS Notification Data Fields ... 34

3.1.6.3 Retrieve from undesignated place on ÜTS Sample Request ... 36

3.1.6.4 Retrieve from undesignated place on ÜTS Notification with Unique Device Identifier Service Address.... 36

3.1.6.5 Retrieve from undesignated place on ÜTS Notification with Unique Device Identifier Data Fields ... 36

3.1.6.6 Retrieve from undesignated place on ÜTS Notification with Unique Device Identifier Sample Request ... 37

3.1.7.1 Usage Notification Service Address ... 37

3.1.7.2 Usage Notification Data Fields ... 37

3.1.7.3 Import Notification Sample Request ... 39

3.1.7.4 Usage Notification with Unique Device Identifier Information Service Address ... 39

3.1.7.5 Usage Notification with Unique Device Identifier Information Data Fields ... 39

3.1.7.6 Usage Notification with Unique Device Identifier Information Sample Request ... 41

3.1.8.1 Delivery to Consumer Notification Service Address ... 41

3.1.8.2 Delivery to Consumer Notification Data Fields ... 41

3.1.8.3 Delivery to Consumer Notification Sample Request ... 43

3.1.8.4 Delivery to Consumer Notification with Unique Device Identifier Information Service Address ... 43

3.1.8.5 Delivery to Consumer Notification with Unique Device Identifier Information Data Fields ... 43

3.1.8.6 Delivery to Consumer Notification with Unique Device Identifier Information Sample Request ... 45

3.1.9.1 Retrieve from Consumer Notification Service Address ... 45

3.1.9.2 Retrieve from Consumer Notification Data Fields ... 45

3.1.9.3 Retrieve from Consumer Notification Sample Request ... 47

3.1.9.4 Retrieve from Consumer Notification with Unique Device Identifier Information Service Address ... 48

3.1.9.5 Retrieve from Consumer Notification with Unique Device Identifier Information Data Fields ... 48

3.1.9.6 Retrieve from Consumer Notification with Unique Device Identifier Information Sample Request ... 49

3.1.10.1 Delivery for Temporary Usage Notification Service Address ... 49

3.1.10.2 Delivery for Temporary Usage Notification Data Fields ... 49

3.1.10.3 Delivery for Temporary Usage Notification Sample Request ... 50

3.1.10.4 Delivery for Temporary Usage Notification with Unique Device Identifier Information Service Address.... 51

3.1.10.5 Delivery for Temporary Usage Notification with Unique Device Identifier Information Data Fields ... 51

3.1.10.6 Delivery for Temporary Usage Notification with Unique Device Identifier Information Sample Request ... 52

3.1.11.1 Retrieve from Usage Notification Service Address ... 52

3.1.11.2 Retrieve from Usage Notification Data Fields ... 52

3.1.11.3 Retrieve from Usage Notification Sample Request ... 54

3.1.7 USAGE NOTIFICATION ...37

3.1.8 DELIVERY TO CONSUMER NOTIFICATION ...41

3.1.9 RETRIEVE FROM CONSUMER NOTIFICATION ...45

3.1.10 DELIVERY FOR TEMPORARY USAGE NOTIFICATION ...49

3.1.11 RETRIEVE FROM USAGE NOTIFICATION ...52

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3.1.12.3 Reprocessing Notification Sample Request ... 56

3.1.12.4 Reprocessing Notification with Unique Device Identifier Information Service Address ... 56

3.1.12.5 Reprocessing Notification with Unique Device Identifier Information Data Fields ... 56

3.1.12.6 Reprocessing Notification with Unique Device Identifier Information Sample Request ... 57

3.1.13.1 Export Notification Service Address ... 57

3.1.13.2 Export Notification Data Fields ... 57

3.1.13.3 Export Notification Sample Request ... 58

3.1.13.4 Export Notification with Unique Device Identifier Information Service Address ... 59

3.1.13.5 Export Notification with Unique Device Identifier Information Data Fields ... 59

3.1.13.6 Export Notification with Unique Device Identifier Information Sample Request ... 59

3.1.14.1 Return to Country of Origin Notification Service Address ... 60

3.1.14.2 Return to Country of Origin Data Fields ... 60

3.1.14.3 Return to Country of Origin Notification Sample Request ... 60

3.1.14.4 Return to Country of Origin Notification with Unique Device Identifier Information Service Address... 61

3.1.14.5 Return to Country of Origin Notification with Unique Device Identifier Information Data Fields ... 61

3.1.14.6 Return to Country of Origin Notification with Unique Device Identifier Information Sample Request ... 61

3.1.15.1 SOU / Loss Notification Service Address ... 62

3.1.15.2 SOU / Loss Notification Data Fields ... 62

3.1.15.3 SOU / Loss Notification Sample Request ... 63

3.1.15.4 SOU / Loss Notification with Unique Device Identifier Information Service Address ... 63

3.1.15.5 SOU / Loss Notification with Unique Device Identifier Information Data Fields ... 63

3.1.15.6 SOU / Loss Notification with Unique Device Identifier Information Sample Request ... 64

3.1.16.1 Recall/Withdrawal Delivery Notification Service Address ... 64

3.1.16.2 Recall/Withdrawal Delivery Notification Data Fields ... 64

3.1.16.3 Recall/Withdrawal Delivery Notification Sample Request ... 65

3.1.16.4 Recall/Withdrawal Delivery Notification with Unique Device Identifier Information Service Address ... 65

3.1.16.5 Recall/Withdrawal Delivery Notification with Unique Device Identifier Information Data Fields ... 66

3.1.16.6 Recall/Withdrawal Delivery Notification with Unique Device Identifier Information Sample Request ... 66

3.1.13 EXPORT NOTIFICATION ...57

3.1.14 RETURN TO COUNTRY OF ORIGIN NOTIFICATION ...60

3.1.15 SOU/ LOSS NOTIFICATION ...62

3.1.16 RECALL/WITHDRAWAL DELIVERY NOTIFICATION ...64

3.1.17 RECALL/WITHDRAWAL RECEIVE NOTIFICATION ...67

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3.1.17.1 Recall/Withdrawal Receive Notification Service Address ... 67

3.1.17.2 Recall/Withdrawal Receive Notification Data Fields ... 67

3.1.17.3 Recall/Withdrawal Receive Notification Sample Request ... 68

3.1.17.4 Recall/Withdrawal Receive Notification with Unique Device Identifier Information Service Address ... 69

3.1.17.5 Recall/Withdrawal Receive Notification with Unique Device Identifier Information Data Fields ... 69

3.1.17.3 Recall/Withdrawal Delivery Notification with Unique Device Identifier Information Sample Request ... 70

3.1.18.1 Improvement / Corrective Action Notification Service Address ... 70

3.1.18.2 Improvement / Corrective Action Notification Data Fields ... 70

3.1.18.3 Improvement / Corrective Action Notification Sample Request ... 71

3.1.18.4 Improvement / Corrective Action Notification with Unique Device Identifier Information Service Address 71 3.1.18.5 Improvement / Corrective Action Notification with Unique Device Identifier Information Data Fields ... 72

3.1.18.6 Improvement / Corrective Action Notification with Unique Device Identifier Information Sample Request 72 3.1.19.1 Destruction / Disposal Notification Service Address ... 73

3.1.19.2 Destruction / Disposal Notification Data Fields ... 73

3.1.19.3 Destruction / Disposal Notification Sample Request ... 74

3.1.19.4 Destruction / Disposal Notification with Unique Device Identifier Information Service Address ... 75

3.1.19.5 Destruction / Disposal Notification with Unique Device Identifier Information Data Fields ... 75

3.1.19.6 Destruction / Disposal Notification with Unique Device Identifier Information Sample Request ... 76

3.1.20.1 Removal from Patient’s Body Notification Service Address ... 77

3.1.20.2 Removal from Patient’s Body Notification Data Fields ... 77

3.1.20.3 Removal from Patient’s Body Notification Sample Request ... 78

3.1.20.4 Removal from Patient’s Body Notification with Unique Device Identifier Information Service Address ... 79

3.1.20.5 Removal from Patient’s Body Notification with Unique Device Identifier Information Data Fields ... 79

3.1.20.6 Removal from Patient’s Body Notification with Unique Device Identifier Information Sample Request ... 80

3.1.21.1 Lend Notification Service Address ... 80

3.1.21.2 Lend Notification Data Fields ... 81

3.1.21.3 Lend Notification Sample Request ... 81

3.1.21.4 Lend Notification with Unique Device Identifier Information Service Address ... 82

3.1.21.5 Lend Notification with Unique Device Identifier Information Data Fields ... 82

3.1.21.6 Lend Notification with Unique Device Identifier Information Sample Request ... 82

3.1.22.1 Borrow Notification Service Address ... 83

3.1.22.2 Borrow Notification Data Fields ... 83

3.1.22.3 Borrow Notification Sample Request ... 84

3.1.18 IMPROVEMENT /CORRECTIVE ACTION NOTIFICATION ...70

3.1.19 DESTRUCTION /DISPOSAL NOTIFICATION ...72

3.1.20 REMOVAL FROM PATIENTS BODY NOTIFICATION ...77

3.1.21 LEND NOTIFICATION ...80

3.1.22 BORROW NOTIFICATION ...83

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3.1.23.3 Borrow Return Notification Sample Request ... 87

3.1.23.4 Borrow Return Notification with Unique Device Identifier Information Service Address ... 87

3.1.23.5 Borrow Return Notification with Unique Device Identifier Information Data Fields... 87

3.1.23.6 Borrow Return Notification with Unique Device Identifier Information Sample Request ... 88

3.1.24.1 Borrow Retrieve Notification Service Address ... 88

3.1.24.2 Borrow Retrieve Notification Data Fields ... 88

3.1.24.3 Borrow Retrieve Notification Sample Request ... 90

3.1.24.4 Borrow Retrieve Notification with Unique Device Identifier Information Service Address ... 90

3.1.24.5 Borrow Retrieve Notification with Unique Device Identifier Information Data Fields ... 91

3.1.24.6 Borrow Retrieve Notification with Unique Device Identifier Information Sample Request ... 92

3.2 CANCELLATION NOTIFICATIONS...92

3.2.1.1 Cancellation Notification Data Fields ... 93

3.2.1.2 Cancellation Notifications Sample Request ... 94

3.3 NOTIFICATION RESPONSE ...94

3.4 INQUIRING SERVICES ...95

3.4.1.1 Individual Product Inquiry Service Address ... 95

3.4.1.2 Individual Product Inquiry Request Data Fields ... 95

3.4.1.3 Individual Product Inquiry Response Data Fields ... 95

3.4.1.4 Individual Product Inquiry Sample Request ... 98

3.4.1.5 Individual Product Inquiry with Unique Device Identifier Service Address ... 98

3.4.1.6 Individual Product Inquiry with Unique Device Identifier Data Fields ... 98

3.4.1.7 Individual Product Inquiry with Unique Device Identifier Sample Request ... 98

3.4.2.1 Producer/Importer Individual Product Inquiry Service Address ... 99

3.4.2.2 Producer/Importer Individual Product Inquiry Request Data Fields ... 99

3.4.2.3 Producer/Importer Individual Product Inquiry Response Data Fields ... 99

3.4.2.4 Producer/Importer Individual Product Inquiry Sample Request ... 101

3.1.24 BORROW RETRIEVE NOTIFICATION ...88

3.2.1 CANCELLATION NOTIFICATIONS SERVICE ADDRESSES ...92

3.3.1 NOTIFICATION RESPONSE DATA FIELDS ...94

3.4.1 INDIVIDUAL PRODUCT INQUIRY ...95

3.4.2 PRODUCER/IMPORTER INDIVIDUAL PRODUCT INQUIRY ...99

3.4.3 PRODUCERS /IMPORTERS QUERY SERVICE FOR AN INDIVIDUAL PRODUCT THAT WENT OUT OF THE SYSTEM .101

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3.4.3.1 Producer’s / Importer’s Query Service for an Individual Product That Went Out of the System Service Address 102

3.4.3.2 Producer’s / Importer’s Query Service for an Individual Product That Went Out of the System Request

Data Fields ... 102

3.4.3.3 Producer’s / Importer’s Query Service for an Individual Product That Went Out of the System Response Data Fields ... 102

3.4.3.4 Producer’s / Importer’s Query Service for an Individual Product That Went Out of the System Sample Request 106 3.4.4.1 Pending Individual Product Inquiry Service Address ... 106

3.4.4.2 Pending Individual Product Inquiry Request Data Fields ... 106

3.4.4.3 Pending Individual Product Inquiry Response Data Fields ... 107

3.4.4.4 Pending Individual Product Inquiry Sample Request ... 109

3.4.5.1 Borrowed Individual Product Inquiry Service Address ... 110

3.4.5.2 Borrowed Individual Product Inquiry Request Data Fields ... 110

3.4.5.3 Borrowed Individual Product Inquiry Request Data Fields ... 110

3.4.5.4 Borrowed Individual Product Inquiry Sample Request ... 113

3.4.6.1 Query Notification Service Address ... 113

3.4.6.2 Query Notification Request Data Fields ... 113

3.4.6.3 Query Notification Response Data Fields ... 114

3.4.6.4 Query Notification Sample Request ... 119

3.4.7.1 Query Individual Product to be Accepted Service Address ... 119

3.4.7.2 Query Individual Product to be Accepted Request Data Fields ... 119

3.4.7.3 Query Individual Product to be Accepted Response Data Fields ... 120

3.4.7.4 Individual Product to be Accepted Inquiry Sample Request ... 122

3.4.8.1 Individual Product to be Borrowed Inquiry Service Address ... 122

3.4.8.2 Individual Product to be Borrowed Inquiry Request Data Fields ... 122

3.4.8.3 Individual Product to be Borrowed Inquiry Request Data Fields ... 123

3.4.8.4 Individual Product to be Borrowed Inquiry Sample Request ... 126

3.4.9.1 Query Withdrawn Individual Product to be Accepted Service Address ... 126

3.4.9.2 Query Withdrawn Individual Product to be Accepted Request Data Fields ... 126

3.4.9.3 Query Withdrawn Individual Product to be Accepted Request Data Fields ... 126

3.4.9.4 Query Withdrawn Individual Product to be Accepted ... 128

3.4.4 PENDING INDIVIDUAL PRODUCT INQUIRY ...106

3.4.5 QUERY BORROWED INDIVIDUAL PRODUCT ...110

3.4.6 QUERY NOTIFICATION ...113

3.4.7 QUERY INDIVIDUAL PRODUCT TO BE ACCEPTED ...119

3.4.8 QUERY INDIVIDUAL PRODUCT TO BE BORROWED ...122

3.4.9 QUERY WITHDRAWN INDIVIDUAL PRODUCT TO BE ACCEPTED ...126

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3.5.2.1 Delete Packet Service Address ... 132

3.5.2.2 Delete Packet Request Data Fields ... 132

3.5.2.3 Delete Packet Response Data Fields ... 132

3.5.2.4 Delete Packet Sample Request ... 133

3.5.3.1 Query Packet Service Address ... 133

3.5.3.2 Query Packet Request Data Fields ... 134

3.5.3.3 Query Packet Response Data Fields ... 134

3.5.3.4 Query Packet Sample Request ... 135

3.5.4.1 Mark as Read the Packet that Arrived at the Organization Service Address ... 135

3.5.4.2 Mark as Read the Packet that Arrives at the Organization Request Data Fields ... 135

3.5.4.3 Mark as Read the Packet that Arrives at the Organization Response Data Fields ... 136

3.5.4.4 Mark as Read the Packet that Arrived at the Organization Sample Request ... 137

3.5.5.1 Bring the Packet that Arrived at the Organization Service Address ... 137

3.5.5.2 Bring the Packet that Arrived at the Organization Request Data Fields ... 137

3.5.5.3 Bring the Packet that Arrived at the Organization Response Data Fields ... 137

3.5.5.4 Query Packet that Arrived at Organization Sample Request ... 139

3.5.6.1 Query the Packets that Arrived at the Organization Service Address ... 139

3.5.6.2 Query the Packet that Arrived at the Organization Request Data Fields ... 139

3.5.6.3 Query the Packets that Arrived at the Organization Response Data Fields ... 140

3.5.6.4 Query Packets that Arrived at Organization Sample Request... 141

3.6 QUERY COMPANY SERVICE ...141

3.7 SEARCH PRODUCT DEFINITION SERVICE ...143

3.5.2 DELETE PACKET ...132

3.5.3 QUERY PACKET ...133

3.5.4 MARK AS READ THE PACKET THAT ARRIVED AT THE ORGANIZATION ...135

3.5.5 BRING THE PACKET THAT ARRIVED AT THE ORGANIZATION ...137

3.5.6 QUERY PACKETS THAT ARRIVED AT ORGANIZATION ...139

3.6.1 QUERY COMPANY SERVICE ADDRESS ...142

3.6.2 QUERY COMPANY SERVICE DATA FIELDS ...142

3.6.3 PRODUCT INQUIRY SERVICE SAMPLE REQUEST ...142

3.7.1 SEARCH PRODUCT DEFINITION SERVICE ADDRESS ...143

3.7.2 SEARCH PRODUCT DEFINITION SERVICE DATA FIELDS ...143

3.7.3 SEARCH PRODUCT DEFINITION SERVICE SAMPLE REQUEST ...143

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4 ANNEXES ...145

4.1 ANNEX-A SERVICE MESSAGES ...145

TABLES

Table 1. Production Notification Data Fields ... 16

Table 2. Import Notification Data Fields ... 20

Table 3. Delivery Notification Data Fields ... 24

Table 4. Delivery Notification Data Fields with Unique Device Identifier Information ... 26

Table 5. Receive notification Data Fields ... 27

Table 6. Receive notification Data Fields with Unique Device Identifier Information ... 29

Table 7. Delivery Notification to a Place Undesignated on ÜTS Data Fields ... 31

Table 8. Delivery Notification with Unique Device Identifier to a Place Undesignated on ÜTS Data Fields ... 32

Table 9 .Retrieve from undesignated place on ÜTS Notification Data Fields ... 34

Table 10. Retrieve from undesignated place on ÜTS Notification with Unique Device Identifier Data Fields ... 36

Table 11.Usage Notification Data Fields ... 37

Table 12. Usage Notification with Unique Device Identifier Information Data Fields ... 39

Table 13.Delivery to Consumer Notification Data Fields ... 41

Table 14. Delivery to Consumer Notification with Unique Device Identifier Information Data Fields ... 43

Table 15 .Retrieve from Consumer Notification Data Fields ... 45

Table 16. Retrieve from Consumer Notification with Unique Device Identifier Information Data Fields ... 48

Table 17 . Delivery for Temporary Usage Notification Data Fields ... 49

Table 18. Delivery for Temporary Usage Notification with Unique Device Identifier Information Data Fields ... 51

Table 19. Retrieve from Usage Notification Data Fields ... 52

Table 20. Retrieve from Usage Notification with Unique Device Identifier Information Data Fields ... 54

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Table 27 .SOU / Loss Notification Data Fields ... 62

Table 28. SOU / Loss Notification with Unique Device Identifier Information Data Fields ... 63

Table 29. Recall/Withdrawal Delivery Notification Data Fields ... 64

Table 30. Recall/Withdrawal Delivery Notification with Unique Device Identifier Information Data Fields ... 66

Table 31. Recall/Withdrawal Receive Notification Data Fields ... 67

Table 32. Recall/Withdrawal Receive Notification with Unique Device Identifier Information Data Fields ... 69

Table 33 .Improvement / Corrective Action Notification Data Fields ... 70

Table 34. Improvement / Corrective Action Notification with Unique Device Identifier Information Data Fields ... 72

Table 35. Destruction / Disposal Notification Data Fields ... 73

Table 36. Destruction / Disposal Notification with Unique Device Identifier Information Data Fields ... 75

Table 37. Removal from Patient’s Body Notification Data Fields ... 77

Table 38. Removal from Patient’s Body Notification with Unique Device Identifier Information Data Fields ... 79

Table 39 . Lend Notification Data Fields ... 81

Table 40. Lend Notification with Unique Device Identifier Information Data Fields ... 82

Table 41. Borrow Notification Data Fields ... 83

Table 42. Borrow Notification with Unique Device Identifier Information Data Fields ... 85

Table 43. Borrow Return Notification Data Fields ... 86

Table 44. Borrow Return Notification with Unique Device Identifier Information Data Fields ... 87

Table 45. Borrow Retrieve Notification Data Fields ... 88

Table 46. Borrow Retrieve Notification with Unique Device Identifier Information Data Fields... 91

Table 47. Cancellation Notifications Service Addresses ... 92

Table 48. Cancellation Notification Data Fields ... 93

Table 49. Notification Response Data Fields ... 94

Table 50. Individual Product Inquiry Request Data Fields ... 95

Table 51. Individual Product Inquiry Response Data Fields ... 95

Table 52. Individual Product Inquiry with Unique Device Identifier Data Fields ... 98

Table 53. Producer/Importer Individual Product Inquiry Request Data Fields ... 99

Table 54. Producer/Importer Individual Product Inquiry Response Data Fields ... 99

Table 55. Producer’s / Importer’s Query Service for an Individual Product That Went Out of the System Request Data Fields ... 102

Table 56. Producer’s / Importer’s Query Service for an Individual Product That Went Out of the System Response Data Fields ... 102

Table 57. Pending Individual Product Inquiry Request Data Fields ... 106

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Table 59. Borrowed Individual Product Inquiry Request Data Fields ... 110

Table 60. Borrowed Individual Product Inquiry Request Data Fields ... 110

Table 61. Query Notification Request Data Fields ... 113

Table 62. Query m Notification Response Data Fields ... 114

Table 63. Query Individual Product to be Accepted Request Data Fields ... 119

Table 64. Query Individual Product to be Accepted Response Data Fields ... 120

Table 65. Individual Product to be Borrowed Inquiry Request Data Fields ... 122

Table 66. Individual Product to be Borrowed Inquiry Request Data Fields ... 123

Table 67. Query Withdrawn Individual Product to be Accepted Request Data Fields ... 126

Table 68. Query Withdrawn Individual Product to be Accepted Request Data Fields ... 126

Table 69. Add Packet Request Data Fields ... 129

Table 70. Add Packet Response Data Fields ... 130

Table 71. Delete Packet Request Data Fields ... 132

Table 72. Delete Packet Response Data Fields ... 132

Table 73. Query Packet Request Data Fields ... 134

Table 74. Query Packet Response Data Fields ... 134

Table 75. Mark as Read the Packet that Arrives at the Organization Request Data Fields ... 135

Table 76. Mark as Read the Packet that Arrives at the Organization Response Data Fields... 136

Table 77. Bring the Packet that Arrived at the Organization Request Data Fields ... 137

Table 78. Bring the Packet that Arrives at the Organization Response Data Fields ... 137

Table 79. Query the Packet that Arrived at the Organization Request Data Fields ... 139

Table 80. Query the Packets that Arrived at the Organization Response Data Fields ... 140

Table 81. Query Company Service Data Fields ... 142

Table 82. Query Product Service Data Fields ... 143

Table 83. Service Messages ... 145

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their information systems according to the web service definitions with ÜTS. The purpose of this document is to provide the information that organizations or companies may need to use the web services provided by ÜTS 1.2 SCOPE

The services that are used for transactions in the scope of both normal actions and return actions for individual products have been described in this document. By using these services companies or organizations will be able to report changes in ownership of individual products, amounts or use figures.

The purpose of each service has been briefly explained in the document; the access address for the service, the parameters necessary to call the service and the data structure of the response returned by the service have been defined.

1.3 TERMS AND ABBREVIATIONS

Term / Abbreviation Definition

BİLGEM Informatics and Information Security ReQuery Center

Action Notification

This is the notification that is made for the action of each lot/party/batch of each individual product. Each action notification has a format that has been pre-assigned by the ÜTS.

Administration TİTCK

JSON JavaScript Object Notation

REST Representational State Transfer

System Product Tracking System

Individual Product The individual unit of each product. For example; each blood pressure gauging instrument or each perfume bottle is an individual product.

TİTCK T.R. Ministry of Health Medicines and Medical Devices Agency TÜBİTAK Scientific and Technological Research Council of Turkey

MERSİS Central Registration System

UDI Unique Device Identification

URL Uniform Resource Locator

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Term / Abbreviation Definition that are registered in the ÜTS.

ÜTS Product Tracking System

YTE Software Technologies ReQuery Institute

2 THE GENERAL STRUCTURE OF WEB SERVICES

2.1 INTEGRATION OF THE ÜTS WITH OTHER INFORMATION SYSTEMS

All of the functions that the ÜTS provides to users are in standard REST services form. These functions can be used through the user interfaces provided by ÜTS and are also open to integration with other information systems.

In order for users to integrate their own information systems to ÜTS they must obtain an integration key by using the PTS interfaces. The integration key is a code produced using e-signature. This is called a code system token.

The purpose of the system code is to verify the identity of information systems that wish to send notification to ÜTS and to determine the limits of their authority.

After the user information system obtains the system token they must add the system token's value with the utsToken label to the header section of each web service call they make. Otherwise when the system token is not added to the header section of the REST call with the utsToken label a PTS authorization error will appear and will not complete the transaction.

Users can obtain the system token they will use to integrate their own information systems to ÜTS by following the below steps (The users that will be following these steps must have signature authority in their company / organization). Whether or not users have signature authority shall be automatically searched from MERSIS.).

1. With a user in the authorized user group the address “https://utsuygulama.saglik.gov.tr1” can be used to enter ÜTS. If necessary the user must use the “Change Account” link to enter the relevant account of the organization / company they want to do a transaction on.

2. The user will choose the “User  System User Assignment Transactions” option from the menu.

3. The user will sign the text that appears on the screen using e-signature.

4. The PTS will create a system token for the user and the user will copy this token to their own information system.

1 The Product Actions and Product Call Back Modules also provide service in the PTS test setting (https://utstest.saglik.gov.tr). Companies can also use the test setting to do a trial. The data in the test setting will

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When evaluated in terms of individual product actions the ÜTS is a closed system. Individual products start to be in the System (ÜTS) with their Production or Import notification. Individual products change hands between organizations/companies assigned on the System with their Delivery and Receive notifications. When an individual product is given to an organization/company that is not assigned to the ÜTS the "Delivery to Undesignated Place Notification" is used on ÜTS. The individual product will go off the System with this notification. The "Delivery to Consumer Notification" is used for individual products that are given to patients or consumers for a fee or free of charge. The individual product will go off the System with the "Delivery to Consumer Notification".

The actions of individual products with a recall on them can be restricted. Specialized services have been designated for individual products with restricted action.

Each notification has been explained in a separate section. The address of the service to which the notification will be called and fields that must be sent with the service call have been specified.

The data structures that the service rotates as a result of all action notifications are common. This data structure has been explained under the heading number 3.2.1.2.

3.1.1 Production Notification

The Producer makes a Production Notification for each individual product they produce.

3.1.1.1 Production Notification Service Address

Real Setting: https://utsuygulama.saglik.gov.tr/UTS/uh/rest/bildirim/uretim/ekle Test Setting: https://utstest.saglik.gov.tr/UTS/uh/rest/bildirim/uretim/ekle 3.1.1.2 Production Notification Data Fields

Table 1. Production Notification Data Fields

Name JSON

Code Data Type

Maximum Length (Characte

r)

Require

d? Explanation

Product Number UNO Text 23 Yes The product's product number/barcode

number.

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Name JSON

Code Data Type

Maximum Length (Characte

r)

Require

d? Explanation

Lot/Batch

Number LNO Text 20 Condition

al

Required to submit for products tracked by lot.

Serial/Order

Number SNO Text 20 Condition

al

Required to submit for products tracked individually.

Production Date URT Date 10 Yes In YYYY-MM-DD format. Y: Year, M:

Month, D: Day.

Expiry Date SKT Date 13 No

In YYYY-MM-DD TT format. Y: Year, M:

Month, D: Day, T: Time.

Time is not given for GS1 products.

Time and day fields may not be given according to HIBCC product properties.

Item ADT Number - Condition

al

Not given for products tracked individually.

Specifies how many were produced from the same lot/series/batch for products tracked by lot.

Required to submit for products tracked by lot.

Unique Device

Identifier UDI Text - Condition

al

If available the Unique Device Identifier of an individual product known as Unique Device Identifier (UDI) or Datamatrix can be given.

System and Procedure

Packs

SIP

List (BRK, UNO,

LNO, SNO, ADT)

- Condition al

Required if the individual product has a System and Procedure Packs and there is at least one product in it that is in the scope of tracking.

The information provided in the list is sub individual product information.

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Cosmetic

Product Set KUS

List (BRK, UNO,

LNO, SNO, ADT)

- Condition al

Required if the individual product is a cosmetic product set and there is at least one product in it that is in the scope of tracking.

The information provided in the list is sub individual product information.

Voluntary

Tracking Scope GTK Single Option

List 5 No

Required field for voluntary tracking by companies of products that do not have any tracking configuration.

It can take on one of the values below.

 INDIVIDUAL

 LOT

3.1.1.3 Production Notification Sample Request Sample 1 product with lot tracking:

{

"UNO" : "1111111110324",

"LNO" : "250515186001",

"ADT" : 100,

"UDI" : "011111111110324111603021719030210250515186001",

"URT" : "2016-03-02",

"SKT" : "2019-03-02"

}

Sample 2 product with individual tracking:

{

"UNO" : "1111111110010",

"SNO" : "KYY012345678999",

"UDI" : "011111111110010111603021719030221KYY012345678999",

"URT" : "2016-03-02",

"SKT" : "2019-03-02"

}

(19)

NOTE: On individually tracked products the “ADT” information must be entered as “1” or o field should not be entered.

Sample 3 individually tracked System and Procedure Packs:

{

"UNO" : "9321502013475",

"SNO" : "112212345678MM9",

"UDI" : "019321502013475111603021719030221112212345678MM9",

"ADT" : 1,

"URT" : "2016-03-02",

"SKT" : "2019-03-02",

"SIP" : [

{

"UNO" : "2451643000038",

"SNO" : "B8NN12345678999"

}, {

"UNO" : "2451643000007",

"LNO" : "250515186001", "ADT" : 10

} ]

}

Sample 4 production by voluntarily tracking a product without a tracking configuration individually:

{

"UNO" : "1111111110010",

"SNO" : "KYY012345678999",

"UDI" : "011111111110010111603021719030221KYY012345678999",

"URT" : "2016-03-02",

"SKT" : "2019-03-02",

"GTK" : "INDIVIDUAL"

}

3.1.2 Import Notification

An Importer makes an Import Notification for the individual products they import.

3.1.2.1 Import Notification Service Address

Real Setting: https://utsuygulama.saglik.gov.tr/UTS/uh/rest/bildirim/ithalat/ekle Test Setting: https://utstest.saglik.gov.tr/UTS/uh/rest/bildirim/ithalat/ekle

(20)

Name

Code Data Type

(Characte r)

d? Explanation

Product Number UNO Text 23 Yes The product's product number/barcode

number.

Lot/Batch

Number LNO Text 20 Condition

al

Required to submit for products tracked by lot.

Serial/Order

Number SNO Text 20 Condition

al

Required to submit for products tracked individually.

Production Date URT Date 10 Yes

In YYYY-MM-DD format. Y: Year, M:

Month and D: Means day.

If an import date has been provided for cosmetic products the production date can be omitted.

Expiry Date SKT Date 13 No

In YYYY-MM-DD TT format. Y: Year, M:

Month, D: Means Day and T means time.

Time is not given for GS1 products.

Time and day fields may not be given according to HIBCC product properties.

Import Date ITT Date 10 Condition

al

In YYYY-MM-DD format. Y: Year, M:

Month and D: Means day.

The import date must be provided for cosmetic products when the production date is not known.

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Name JSON

Code Data Type

Maximum Length (Characte

r)

Require

d? Explanation

Item ADT Number - Condition

al

Not given for products tracked individually.

Specifies how many were imported from the same lot/series/batch for products tracked by lot.

Required to submit for products tracked by lot.

Unique Device

Identifier UDI Text - Condition

al

If available the Unique Device Identifier of an individual product known as Unique Device Identifier (UDI) or Datamatrix can be given.

Imported

Country IEU Number 3 Yes The country code. *

Origin Country MEU Number 3 Yes The country code. *

Customs Declaration

Number

GBN Text 16 Yes -

System and Procedure

Packs

SIP

List (BRK, UNO,

LNO, SNO, ADT)

- Condition al

Required if the individual product has a System and Procedure Packs and there is at least one product in it that is in the scope of tracking.

The information provided in the list is sub individual product information.

Cosmetic

Product Set KUS

List (BRK, UNO,

LNO, SNO, ADT)

- Condition al

Required if the individual product is a cosmetic product set and there is at least one product in it that is in the scope of tracking.

The information provided in the list is

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Voluntary

Tracking Scope GTK Single Option

List 5 No

Required field for voluntary tracking by companies of products that do not have any tracking configuration.

It can take on one of the values below.

 INDIVIDUAL

 LOT

* The codes published by the Risk Management and Directorate General of Control are used.

3.1.2.3 Import Notification Sample Request

Sample 1 product with lot tracking:

{

"UNO" : "1111111110058",

"LNO" : "250515186001",

"ADT" : 100,

"UDI" : "011111111110058111603021719030210250515186001",

"URT" : "2016-03-02",

"SKT" : "2019-03-02",

"IEU" : "038",

"MEU" : "452",

"GBN" : "15343100IM003176"

}

Sample 2 product with individual tracking:

{

"UNO" : "1111111110065",

"SNO" : "KYY012345678999",

"UDI" : "011111111110065111603021719030221KYY012345678999",

"URT" : "2016-03-02",

"SKT" : "2019-03-02",

"IEU" : "716",

(23)

"GBN" : "15343100IM003176"

}

NOTE: On individually tracked products the “ADT” information must be entered as “1” or o field should not be entered.

Sample 3 individually tracked System and Procedure Packs:

{

"UNO" : "851479856540",

"SNO" : "112212345678MM9",

"UDI" : "01851479856540111603021719030221112212345678MM9",

"ADT" : 1,

"URT" : "2016-03-02",

"SKT" : "2019-03-02",

"IEU" : "400",

"MEU" : "400",

"GBN" : "15343100IM003176",

"SIP" : [

{

"UNO" : "1111111110065",

"SNO" : "KYY012345678999"

}, {

"UNO" : "1111111110058",

"LNO" : "250515186001", "ADT" : 1

} ]

}

Sample 4 importing by voluntarily tracking a product without a tracking configuration individually:

{

"UNO" : "1111111110065",

"SNO" : "KYY012345678999",

"UDI" : "011111111110065111603021719030221KYY012345678999",

"URT" : "2016-03-02",

"SKT" : "2019-03-02",

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3.1.3 Delivery Notification

When the organization/company gives the individual products they own to another organization/company they make a Delivery Notification. Delivery Notifications are made for sales, donations, returns, etc.

3.1.3.1 Delivery Notification Service Address

Real Setting: https://utsuygulama.saglik.gov.tr/UTS/uh/rest/bildirim/verme/ekle

Test Setting: https://utstest.saglik.gov.tr/UTS/uh/rest/bildirim/verme/ekleDelivery Notification Data Fields Table 3. Delivery Notification Data Fields

Name JSON

Code Data Type

Maximum Length (Characte

r)

Require

d? Explanation

Product Number UNO Text 23 Yes The product's product number/barcode

number.

Lot/Batch

Number LNO Text 20 Condition

al

Required to submit for products tracked by lot.

Serial/Order

Number SNO Text 20 Condition

al

Required to submit for products tracked individually.

Item ADT Number - Condition

al

Not given for products tracked individually.

Specifies how many were given from the same lot/series/batch for products tracked by lot.

Required to submit for products tracked by lot.

Organization No KUN Number - Yes

The number of the

organization/company assigned on the ÜTS that the individual product was given to.

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Name JSON

Code Data Type

Maximum Length (Characte

r)

Require

d? Explanation

Free Sample BEN Single Option

List 5 No

Specifies whether the given individual products were free samples or not.

They may take on the values below.

The default value is NO.

 YES: Yes

 NO: No

Document

Number BNO Text 50 Yes The invoice and/or Dispatch note

number.

3.1.3.2 Delivery Notification Sample Request {

"UNO" : "2451643000007",

"LNO" : "250515186001",

"ADT" : 25,

"KUN" : 7,

"BEN" : "NO",

"BNO" : "123B"

}

3.1.3.3 Delivery Notification Service Address with Unique Device Identifier Information Real Setting: https://utsuygulama.saglik.gov.tr/UTS/uh/rest/bildirim/verme/ekle/essizKimlik Test Setting: https://utstest.saglik.gov.tr/UTS/uh/rest/bildirim/verme/ekle/essizKimlik 3.1.3.4 Delivery Notification Data Fields with Unique Device Identifier Information

Table 4. Delivery Notification Data Fields with Unique Device Identifier Information

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Unique Device

Identifier UDI Text - Required

This must be provided when you want to make a notification with the individual product unique identity known as the Unique Device Identifier (UDI) or Datamatrix.

Item ADT Number - No

Not given for products tracked individually.

Specifies how many were taken from the same lot/series/batch for products tracked by lot.

Used when an amount of individual products less than what was given is taken.

The item amount information in the default value Delivery Notification.

Organization No KUN Number - Yes

The number of the

organization/company assigned on the ÜTS that the individual product was given to.

Document

Number BNO Text 50 Yes The invoice and/or Dispatch note

number.

3.1.3.5 Delivery Notification with Unique Device Identifier Information Sample Request {

“UDI” : “0151022222233336111603021719030210A213B1211234”,

"KUN" : 7,

"ADT" : 5,

"BNO" : "123"

}

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3.1.4 Receive notification

The organization/company makes a Receive notification to accept individual products given to them. With this notification the individual product ownership passes to the receiving side.

3.1.4.1 Receive notification Service Address

Real Setting: https://utsuygulama.saglik.gov.tr/UTS/uh/rest/bildirim/alma/ekle Test Setting: https://utstest.saglik.gov.tr/UTS/uh/rest/bildirim/alma/ekle 3.1.4.2 Receive notification Data Fields

Table 5. Receive notification Data Fields

Name JSON

Code Data Type

Maximum Length (Characte

r)

Require

d? Explanation

Delivery

Notification ID VBI Number - Condition

al

Shows which Delivery Notification the product is being taken against.

Item ADT Number - No

Not given for products tracked individually.

Specifies how many were taken from the same lot/series/batch for products tracked by lot.

Used when an amount of individual products less than what was given is taken.

The item amount information in the default value Delivery Notification.

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Sending Organization

Number

GKK Number - Condition

al

The number of the notifying

organization that is assigned on the ÜTS.

If Delivery Notifications have been made by different organizations for the individual products that have the same individual product information in an organization this is necessary to specify the Delivery Notification from which organization you want to make a receive notification against.

Unique Device

Identifier UDI Text - Condition

al

This must be provided to make a receive notification with a Unique Device Identifier when a notification code is not provided.

Product Number UNO Text 23 Condition

al

The product's product number/barcode number.

If a notification code or unique device identifier is not provided the product number must be provided when you want to take with the individual product information.

Lot/Batch

Number LNO Text 20 Condition

al

If a notification code or unique device identifier is not provided the product number must be provided when you want to receivewith the individual product information.

Required to submit for products tracked by lot.

(29)

Name JSON

Code Data Type

Maximum Length (Characte

r)

Require

d? Explanation

Serial/Order

Number SNO Text 20 Condition

al

If a notification code or unique device identifier is not provided the product number must be provided when you want to receivewith the individual product information.

Required to submit for products tracked individually.

3.1.4.3 Receive notification Sample Request

Sample 1 receive notification request made with Delivery Notification ID:

{

"VBI" : "5d59e861-0ecc-11e7-a708-f52ed20ddd29",

"ADT" : 15 }

Sample 2 receive notification request made with lot/batch no and series/order no:

{

"UNO" : "1111111110324",

"LNO" : "250515186001",

"ADT" : 5,

“GKK" : 10 }

3.1.4.4 Receive notification Service Address with Unique Device Identifier Information Real Setting: https://utsuygulama.saglik.gov.tr/UTS/uh/rest/bildirim/alma/ekle/essizKimlik Test Setting: https://utstest.saglik.gov.tr/UTS/uh/rest/bildirim/alma/ekle/essizKimlik 3.1.4.5 Receive notification Data Fields with Unique Device Identifier Information

Table 6. Receive notification Data Fields with Unique Device Identifier Information

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Unique Device

Identifier UDI Text - Required

This must be provided to make a receive notification with a Unique Device Identifier when a notification code is not provided.

Item ADT Number - No

Not given for products tracked individually.

Specifies how many were taken from the same lot/series/batch for products tracked by lot.

Used when an amount of individual products less than what was given is taken.

The item amount information in the default value Delivery Notification.

Sending Organization

Number

GKK Number - No

The number of the notifying

organization that is assigned on the ÜTS.

If Delivery Notifications have been made by different organizations for the unique device identified individual products that have the same individual product information in an organization this is necessary to specify the Delivery Notification from which organization you want to make a receive notification against.

3.1.4.6 Receive notification with Unique Device Identifier Information Sample Request {

“UDI” : “0151022222233336111603021719030210A213B1211234”,

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"GKK" : 10 }

3.1.5 Delivery Notification to a Place Undesignated on ÜTS

When an organization/company gives an individual product to a company that is not assigned on the ÜTS they make a Delivery Notification to a Place Undesignated on ÜTS.

3.1.5.1 Delivery Notification to a Place Undesignated on ÜTS Service Address

Real Setting: https://utsuygulama.saglik.gov.tr/UTS/uh/rest/bildirim/utsdeTanimsizYereVerme/ekle Test Setting: https://utstest.saglik.gov.tr/UTS/uh/rest/bildirim/utsdeTanimsizYereVerme/ekle

3.1.5.2 Delivery Notification to a Place Undesignated on ÜTS Data Fields

Table 7. Delivery Notification to a Place Undesignated on ÜTS Data Fields

Name JSON

Code Data Type

Maximum Length (Characte

r)

Require

d? Explanation

Product Number UNO Text 23 Yes The product's product number/barcode

number.

Lot/Batch

Number LNO Text 20 Condition

al

Required to submit for products tracked by lot.

Serial/Order

Number SNO Text 20 Condition

al

Required to submit for products tracked individually.

Item ADT Number - Condition

al

Not given for products tracked individually.

Specifies how many were given from the same lot/series/batch for products tracked by lot.

Required to submit for products tracked by lot.

(32)

Free Sample BEN Single Option

List 5 No

Specifies whether the given individual products were free samples or not.

They may take on the values below.

The default value is NO.

 YES: Yes

 NO: No

Tax

Identification No VKN Number - Yes

It is mandatory to enter the tax

identification number of a company not registered on ÜTS.

Document

Number BNO Text 50 Yes The invoice and/or Dispatch note

number.

3.1.5.3 Delivery Notification to a Place Undesignated on ÜTS Sample Request {

"UNO" : "1111111110058",

"LNO" : "250515186001",

"ADT" : 25,

"VKN" : "1234567890",

"BNO" : "123B",

"BEN" : "NO"

}

3.1.5.4 Delivery Notification with Unique Device Identifier to a Place Undesignated on ÜTS Service Address

Real Setting: https://utsuygulama.saglik.gov.tr/UTS/uh/rest/bildirim/utsdeTanimsizYereVerme/ekle/essizKimlik Test Setting: https://utstest.saglik.gov.tr/UTS/uh/rest/bildirim/utsdeTanimsizYereVerme/ekle/essizKimlik

3.1.5.5 Delivery Notification with Unique Device Identifier to a Place Undesignated on ÜTS Data Fields Table 8. Delivery Notification with Unique Device Identifier to a Place Undesignated on ÜTS Data Fields

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Name JSON

Code Data Type

Maximum Length (Characte

r)

Require

d? Explanation

Unique Device

Identifier UDI Text - Required

Must be provided when you want to make a notification with Unique Device Identifier.

Item ADT Number - Condition

al

Not given for products tracked individually.

Specifies how many were given from the same lot/series/batch for products tracked by lot.

Required to submit for products tracked by lot.

Free Sample BEN Single Option

List 5 No

Specifies whether the given individual products were free samples or not.

They may take on the values below.

The default value is NO.

 YES: Yes

 NO: No

Tax

Identification No VKN Number - Yes

It is mandatory to enter the tax

identification number of a company not registered on ÜTS.

MERSİS No MEN Number - Condition

al

Must be provided when the individual product is to be given to a company assigned on MERSİS.

T.R.

Identification No TKN Number - Condition

al

Must be provided when the individual product is to be given to a company assigned on ESBİS.

Vocation Code MEK Number - Condition

al

Must be provided when the individual product is to be given to a company assigned on ESBİS.

(34)

Chamber Code ODK Number - Condition al

Must be provided when the individual product is to be given to a company assigned on ESBİS.

Document

Number BNO Text 50 Yes The invoice and/or Dispatch note

number.

3.1.5.6 Delivery Notification with Unique Device Identifier to a Place Undesignated on ÜTS Sample Request

{

“UDI” : “0151022222233336111603021719030210A213B1211234”,

"ADT" : 5,

"VKN" : "1234567890",

"BNO" : "123B",

"BEN" : "NO"

}

3.1.6 Retrieve from undesignated place on ÜTS Notification

When an organization/company takes back an individual product to a company that is not assigned on the ÜTS they make a Retrieve from undesignated place on ÜTS Notification.

3.1.6.1 Retrieve from undesignated place on ÜTS Notification Service Address

Real Setting: https://utsuygulama.saglik.gov.tr/UTS/uh/rest/bildirim/utsdeTanimsizYerdenIadeAlma/ekle Test Setting: https://utstest.saglik.gov.tr/UTS/uh/rest/bildirim/utsdeTanimsizYerdenIadeAlma/ekle

3.1.6.2 Retrieve from undesignated place on ÜTS Notification Data Fields

Table 9 .Retrieve from undesignated place on ÜTS Notification Data Fields

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Name JSON

Code Data Type

Maximum Length (Characte

r)

Require

d? Explanation

Delivery Notification to a

Place Undesignated

on ÜTS ID

UTI Number - Condition

al

This expresses which Delivery Notification to place Undesignated on ÜTS that the return from place Undesignated on ÜTS is being made against.

Item ADT Number - Condition

al

Not given for products tracked individually.

Specifies how many were given from the same lot/series/batch for products tracked by lot.

Required to submit for products tracked by lot.

Unique Device

Identifier UDI Text - Condition

al

This must be provided to make a receive notification with a Unique Device Identifier when a notification code is not provided.

Product Number UNO Text 23 Condition

al

The product's product number/barcode number.

When you want to make a return with individual product information and the notification code or unique device identifier is not provided, the product number must be provided.

Lot/Batch

Number LNO Text 20 Condition

al

If a notification code or unique device identifier is not provided the product number must be provided when you want to receivea return with the individual product information.

Required to submit for products tracked by lot.

(36)

Serial/Order

Number SNO Text 20 Condition

al

If a notification code or unique device identifier is not provided the product number must be provided when you want to receivea return with the individual product information.

Required to submit for products tracked individually.

3.1.6.3 Retrieve from undesignated place on ÜTS Sample Request

Sample 1 Request for retrieve from undesignated place on ÜTS notification made with retrieve from undesignated place on ÜTS notification ID:

{

"UTI" : "5d59e861-0ecc-11e7-a708-f52ed20ddd29",

"ADT" : 15 }

Sample 2 retrieve from undesignated place on ÜTS notification request made with lot/batch no and series/order no:

{

"UNO" : "1111111110324",

"LNO" : "250515186001",

"ADT" : 5 }

3.1.6.4 Retrieve from undesignated place on ÜTS Notification with Unique Device Identifier Service Address

Real Setting:

https://utsuygulama.saglik.gov.tr/UTS/uh/rest/bildirim/utsdeTanimsizYerdenIadeAlma/ekle/essizKimlik Test Setting: https://utstest.saglik.gov.tr/UTS/uh/rest/bildirim/utsdeTanimsizYerdenIadeAlma/ekle/essizKimlik 3.1.6.5 Retrieve from undesignated place on ÜTS Notification with Unique Device Identifier Data Fields

(37)

Name JSON

Code Data Type

Maximum Length (Characte

r)

Require

d? Explanation

Unique Device

Identifier UDI Text - Required

This must be provided to make a receive notification with a Unique Device Identifier when a notification code is not provided.

Item ADT Number - No

Not given for products tracked individually.

Specifies how many were taken from the same lot/series/batch for products tracked by lot.

Used when an amount of individual products less than what was given is taken.

The item amount information in the default value Delivery Notification.

3.1.6.6 Retrieve from undesignated place on ÜTS Notification with Unique Device Identifier Sample Request

{

"UDI" : "0151022222233336111603021719030210A213B1211234",

"ADT" : 5 }

3.1.7 Usage Notification

When a health organization/application center uses an individual product on a patient/consumer they make a Usage Notification.

3.1.7.1 Usage Notification Service Address

Real Setting: https://utsuygulama.saglik.gov.tr/UTS/uh/rest/bildirim/kullanim/ekle Test Setting: https://utstest.saglik.gov.tr/UTS/uh/rest/bildirim/kullanim/ekle

3.1.7.2 Usage Notification Data Fields

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Product Number UNO Text 23 Yes The product's product number/barcode number.

Lot/Batch

Number LNO Text 20 Condition

al

Required to submit for products tracked by lot.

Serial/Order

Number SNO Text 20 Condition

al

Required to submit for products tracked individually.

Item ADT Number - Condition

al

Not given for products tracked individually.

Specifies how many were used from the same lot/series/batch for products tracked by lot.

Required to submit for products tracked by lot.

Patient Name HAA Text 50 Condition

al

Given if the identification number is necessary when using. (If there is a tracking configuration)

Patient Last

Name HAS Text 50 Condition

al

Given if the identification number is necessary when using. (If there is a tracking configuration)

T.R.

Identification No TKN Number - Condition

al

Given if identification number is needed when using and it is used on a Republic of Turkey citizen. (If there is a tracking configuration)

Foreign

Identification No YKN Number - Condition

al

Given if identification number is needed when using and it is used on a patient with a foreign identification number. (If there is a tracking configuration)

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