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Pharmaceutical Serialization Data Interface
May 2015
1
※ This document was developed as training material and is subject to revision in the future, in accordancewith related laws and regulations.
ContentsContents
Pharmaceutical Serialization Data Interface0101
E-document Preparation for Pharmaceutical Data Interface0202
Pharmaceutical Serialization Flowchart0303
2
Pharmaceutical Serialization Flowchart0303
Pharmaceutical SerializationData InterfacePharmaceutical SerializationData Interface
1. Pharmaceutical Serialization Data Interface1. Pharmaceutical Serialization Data Interface
Interface to Distributors’ Systems0202
Interface to Distributors that Use ASP
Data Gathering Flowchart0101
4
Interface to Distributors that Use ASP0303
Interface to Distributors without Systems0404
Data Gathering FlowchartData Gathering Flowchart
Supply Supply
Health Insurance Review &Assessment Service (KPIS) Manufacturer/i
mporter
Supply data (serial number) reporting (at shipment)
Serial numbers001 ~ 006
Supply data ( serial number) reporting & supply
Serial number006
Supply
1
2
3
58
4
7
5
§ Secure real-time distribution framework of individual medical supplies at the minimum distribution unit level
§ Achieve transparency and stability of pharmaceutical products distribution based on ‘Track and Trace’ structure
Wholesaler A
Supply
Sanitarium Wholesaler B
Supply
Supply data (serial number) reporting & supply
Serial Numbers001~005
Serial numbers 001, 002
Serial numbers003, 004
Serial number001
58
6
- Data interface to distributors’ systems such as Medical Supply Management System & ERP (Enterprise Resource Planning) system
Distributors Health Insurance Review & Assessment Service (KPIS)
Interface system Medical Supply Mgmt. system
Legacy systems,ERP system 1
Interface server
Medical Supply Serialization system
Interface to Distributors’ SystemsInterface to Distributors’ Systems
Agent(provided by
Health Insurance Review &
Assessment Service, HIRA )
ESB Engine
Interface ESB
6
Repository
Medical Supply Serialization system
DB
E-document on medical supplies serialization(File to File)
File to DB
Legacy system, ERP system n
…
Real-time monitoring
Agent(provided by
Health Insurance Review &
Assessment Service, HIRA )
Agent(provided by HIRA)
ESB Engine
Agent
※ ERP (Enterprise Resource Planning): All corporate operations are closely related to each other, requiring integrated management of operations and resources at the enterprise level.
EAI (Enterprise Application integration): An environment to organically link, consolidate, manage and use mutually related applications within an enterpriseESB (Enterprise Service Bus): Advanced data interface technology, supporting message transmission, EAI, Web service and standard data interface
technologies
Distributors ASPHealth Insurance Review & Assessment Service (KPIS)
Interface system Medical Supply Mgmt. System
distributor 1Medical Supply
Serialization system
Interface server
- Data interface between distributors that use ASP happens via ASP agents
Interface to Distributors that Use ASPInterface to Distributors that Use ASP
Interface ESB
7
distributorn
Medical Supply Serialization system
DBFile to DB
Repository
Real-time monitoring
…
APS interface system
File to DB
< E-document on medical supplies serialization>
AgentAgent
(provided by HIRA)
ESB Engine
※ ASP (Application Service Provider): a company that distributes and manages software-based services, solutions, etc. via data centers
Interface to Distributors without SystemsInterface to Distributors without Systems
Distributor
Health Insurance Review & Assessment Service (KPIS)
Interface system Medical Supply Mgmt. System
Interface server
Medical supply serialization system
- Data interface between distributors who do not have Medical Supply Management System - Data interface between distributors in the event of interface system failure (common)
interface ESB
8
※ CSV: Comma Separated Value, text files with commas
Identify current status
< access HIRA portal to directly enter and prepare CSV file >View current status
Medical supply serialization system
DB
Repository
Real-time monitoring
Agent
ESB Engine
interface ESB
PCAgent
Upload CSV File
Enter serial numbers of medical supplies in
Portal
E-document Preparation for Medical Supply Data Interface
E-document Preparation for Medical Supply Data Interface
2. E2. E--document Preparation for Medical Supply Data Interface document Preparation for Medical Supply Data Interface
Supply Data Reporting Template 0101
E-document for Supplier Reporting 0202
E-document Provided to Supplier
10
E-document Provided to Supplier 0303
Supply Data Reporting TemplateSupply Data Reporting Template
Report no. Reportingdate Issuancedate Period
①
Seq
uenti
al no.
②
Supplier
busines
s type
③
Contr
act
meth
od
④
suppl
y
type
⑤
Supply
Customer ⑨
Stan
dard
cod
e
nam
e
⑩
Stand
ard
code
⑪
Product
total Qty.
⑫
Supp
ly
Qty.
⑬
Suppl
y date
⑭
Supp
ly
amo
unt
⑮
Supply
unit
price
⑯
Sub
missi
on
num
ber
⑰
Retur
n
reaso
n
code
⑲
Lot
no.
⑳
Shelf
-life
⑱
Serial
numb
er
㉑
Bundl
e
no.
㉒
RFID tag code
㉓
com
men
t
⑥
Name
⑦
Business
Registrati
on no.
⑧
Sanitarium
ID
.This is to reportmedical supplies supplydata, inaccordancewithArticle45 of EnforcementRule , thePharmaceutical AffairsAct.
Enforcement rule of the Pharmaceutical Affairs Act [Annexed Template] : Supply data status
11
Year month date
㉔ Supplier :
㉕ Business registration
number :
㉖ Representative
(contact)(Signature or stamp)
Cover template
Ø Template no.Ø ㉔ Supplier nameØ ㉕ Supplier business registration no.Ø ④ Supply typeØ ⑦ Buyer’s business registration number
Template ‘A’
Ø Template typeØ ① Sequential number~⑰ Return reason code / ⑲ Lot No., ⑳Shelf-lifeØ Serial no. type
Template ‘B’
Ø Template typeØ ① Sequential number Ø ⑨ Standard codeØ ⑱Serial number Ø ㉑Bundle no~㉓ Comment
1 2 3
EE--document for Supplier Reportingdocument for Supplier Reporting
E-document for supplier reporting to KPIS
Item MODE Description
Template No. an(3)◾ Sent/received template no.
S01: Serialization report template
Supplier name an(100) ◾ State the supplier’s name
Supplier’s Business
Registration No.n(10) ◾ State the supplier’s business registration number
Cover template : Serialization report template (S01)1
12
Supplier’s Business
Registration No.n(10) ◾ State the supplier’s business registration number
Contact (Representative) an(20) ◾ State the supplier contact person (representative)
Supply type n(1)
◾ Indicate the supply type of medical supplies
1: Ship 2: Return 3: Scrap
- If the existing report is to be revised or canceled
4: Correct errors 5: Cancel
Buyer’s Business Registration
No.n(10)
◾ Indicate buyer’s business registration number
- If supply purpose is 1 (for export), 3 (for military supply), 7 (sample) or if supply
type is 3 (scrap), fill in the blank
- If supply purpose is 4 (personal), state the first 7 digits of Resident ‘s Registration no.
EE--document for Supplier Reportingdocument for Supplier Reporting
Template ‘A’
Item MODE Description
Template type n(1) ◾ State the template type as A/B - 1: A 2: B
: Serialization report template (S01)2
①
Seque
ntial
no.
②
Supply
busines
s type
③
Conta
ct type
④
Supply
type
⑤
Suppl
y
purp
ose
Buyer ⑨
Standard code
name
(product name)
⑩
Standard
code
(product
code)
⑪
Package total
count
(size)
⑫
Suppl
y Qty.
⑬
Supply
date
⑭
Supply
amount
(VAT
included)
⑮
Supply unit
price
(VAT
included)
⑯
Submis
sion
numbe
r
⑰
Return
reason
code
⑲
Lot no.
⑳
Shelf-
life
㉓
Comm
ent
⑥
Name
⑦
Business
registration
number
⑧
Sanitarium ID
13
Template type n(1) ◾ State the template type as A/B - 1: A 2: B
Sequential
numbern(6)
◾ State the serial number sequentially (this should not overlap)
- Normal reports: 1,2,3,4,...
☞ requiring revised reporting for returns, error correction, cancellation : Specify the sequential number in
question
Supplier business
typen(1)
◾ State approved item and approved industry type 1: Manufacturing, 2: Import, 3: Wholesale, 4: Manufacturing+import , 5: Manufacturing +wholesale , 6: Import +wholesale, 7: Manufacturing + import+wholesale
Contract type n(1)◾ Indicate contract type
1: Private contract (including donation and scrap ) 2: Competitive bidding
Supply type n(1)◾ Indicate the supply type of medical supplies
1: Ship 2: Return 3: Scrap 4: Correct error 5: Cancel - If the existing report is to be modified or canceled
Supply purpose n(1)
◾ State the supply purpose of medical supplies
1: Export 2: Donation 3: For military 4: Personal use 5: For sanitarium
6: Supplier of medical supplies 7: Sample 8: Emergency medicine seller
9: For special medical facility, academic institution, etc.
EE--document for Supplier Reporting document for Supplier Reporting
Template ‘A’ : Serialization report template (S01)
Item MODE Description
Buyer name an(100)◾ State Buyer’s business title or name
- Fill in the blank if supply type is 1 (for export ) or 3 (for military ).
Buyer’s business registration
number n(10)
◾ State Buyer’s business registration number
- Fill in the blank if supply purpose is 1 (for export), 3 (for military) or 7 (sample).
- If supply purpose is 4 (personal use), state the first 7 digits of Resident’s registration
number.
- Fill in the blank, if supply type is 3 (scrap).
2
14
◾ State Buyer’s business registration number
- Fill in the blank if supply purpose is 1 (for export), 3 (for military) or 7 (sample).
- If supply purpose is 4 (personal use), state the first 7 digits of Resident’s registration
number.
- Fill in the blank, if supply type is 3 (scrap).
Sanitarium ID n(8)◾ If supply purpose is 5 (sanitarium), specify sanitarium ID.
- State “99999999” for those sanitariums without IDs.
Standard code name an(300) ◾ State standard code name assigned based on the minimum packaging unit.
Standard code n(13) ◾ State medical supply standard code assigned based on the minimum packaging unit.
Total count in package n(8) ◾ Total product unit count of packaged medical supplies in the list of KD code
Supply qty. n(8) ◾ State supply Qty. based on standard code unit (positive number).
Supply date n(8)◾ Indicate the supply date of the transaction statement.
- YYYYMMDD (e.g. 20100213)
EE--document document for Supplier Reporting for Supplier Reporting Template ‘A’ : Serialization report template (S01)
Item MODE Description
Supply amount n(12) ◾ Supply amount including VAT (supply unit price × supply Qty.)
Supply unit price n(10) ◾ State unit price including VAT, based on standard code unit (positive number only)
Receipt no.(requiring revised
reporting )n(14)
◾ State the receipt no. of the original report. If supply type is 4 (correct error),
5(cancel) or return report is subject to revised reporting
◾ If the existing return needs to be updated, state the reason code in the original
report
(Example)
* Reason code: DC: (covered by insurance) Prescription medicine unit price error / DH:
(covered by insurance) Over-the-counter medicine unit price error
FH: transfer code error/ FG: representative code error/
DE: (not covered) unit price error / FI: license cancellation code error
Number of digits
1 2 3 4 5 6 7 8 9 0 1 2
Reason code D C D H F H F G D E F I
2
15
Return reason code an(12)
◾ If the existing return needs to be updated, state the reason code in the original
report
(Example)
* Reason code: DC: (covered by insurance) Prescription medicine unit price error / DH:
(covered by insurance) Over-the-counter medicine unit price error
FH: transfer code error/ FG: representative code error/
DE: (not covered) unit price error / FI: license cancellation code error
Manufacture no. (Lot) an(20)◾ Provide Manufacture no. (Number to provide all information of a certain manufacture
unit in terms of manufacturing management and shipping).
Shelf-life n(6)◾ Indicate maximum shelf-life (expiration dates)
- YYMMDD
Serial number type n(1)
◾ Indicate serial number type
0: No serial number, 1: Serial numbers available for all supply Qty.
2: Serial numbers available for a certain quantity
comment an(200) ◾ State comments
Reason code D C D H F H F G D E F I
EE--document for Supplier Reporting document for Supplier Reporting
Template ‘B’ : Serialization report template (S01)
Item MODE Description
Template type n(1) ◾ State template A/B - 1: A 2: B.
Template A
Sequential no.n(6) ◾ State Template A’s sequential number.
3
①
Sequential number
⑩
Standard code (product code)
⑱
Serial number
㉑
Bundle no.
㉒
RFID tag code
16
Template A
Sequential no.n(6) ◾ State Template A’s sequential number.
Standard code n(13) ◾ Indicate standard code.
Serial number an(20)◾ State serial number (unique number assigned for the identification of individual medical
supplies).
Bundle no. an(200)
◾ State up to 5 logistics codes of packaging unit, using ‘/’ as separator.
- e.g. bundle no. 1 / bundle no. 2 / bundle no. 3 / bundle no. 4 / bundle no. 5 : use GTIN14+serial, SSCC
codes
RFID Tag code an(13)◾ Assign RFID Tag code.
- County code(3) + company code(4) + logistics identifier(1) + item code (5) = 13 digits
EE--document for Supplier Reporting document for Supplier Reporting
Template
Cover template
Template A
Template B
S01 Honggildong Pharmaceutical 1122334455 Honggildong16677889900
10000011216 Shimpyeong Pharmaceutical 667788990099999999 Anti-biotics880123456789033201504012997999… …1
200000188012345678901QX987201803310088064111234567891/1880641112345912345 ……200000188012345678902QX987201803310088064111234567891/1880641112345912345 ……200000188012345678903QX987201803310088064111234567891/1880641112345912345 ……
On Apr. 1st, Supplied to Shimpyeong Pharmaceutical 1234567890 or Qty. 3 of 2,997
Serialization and non-serialized report (Example 2)Template On Apr. 1st, Supplied to Shimpyeong Pharmaceutical 1234567890 at unit price 999 Qty. 3 amount 2,997
Serialization report (Example 1)
17
Template
Cover template
Template A
Template B
S01 Honggildong Pharmaceutical 1122334455 Honggildong16677889900
10000011216 c667788990099999999 Anti-biotics 880123456789033201504012997999… …2
200000188012345678901QX987201803310088064111234567891/1880641112345912345 ……200000188012345678902QX987201803310088064111234567891/1880641112345912345 ……
On Apr. 1st, Supplied to Shimpyeong Pharmaceutical 1234567890 at unit price 999 Qty. 3 amount 2,997
Non-serialized and Over-the-counter supply report (Example 3)Template
Cover template
Template A
S01 Honggildong Pharmaceutical 1122334455Honggildong16677889900
10000011216 Shimpyeong Pharmaceutical 667788990099999999anti-biotics 880123456789033201504012997999… …0
On Apr. 1st, Supplied to Shimpyeong Pharmaceutical 1234567890 at unit price 999 Qty. 3 amount 2,997
EE--document for Supplier Reporting document for Supplier Reporting
Cover template : Medical supply RFID Tag request template (S04)
Item MODE Description
Template no. an(3)◾Received/sent template no.
S04: Request RFID tag data
Business registration no. n(10) State requestor’s business registration number
18
Item MODE Description
RFID Tag code n(13)◾Medical supply codes in RFID Tag
- Country code(3)+companycode(4)+logisticsID(1)+itemcode(5)
Serial number an(20)State serial number (unique number assigned for individual identification of medical
supplies )
Data template : Medical supply RFID Tag request template (S04)
EE--document provided to Suppliersdocument provided to Suppliers
E-document that Health Insurance Review & Assessment (KPIS) provides to suppliers
Serialization Notice Template (R01)
E-document for Supplier’s reporting (S01)
Cover template/ Template A / Template B
E-document provided to buyers (R01)
Cover template/ Template A/ Template B 1 2 3 1 2 3
19
• Refer to Serialization report template (S01) for detailed item description
Cover template/ Template A / Template B Cover template/ Template A/ Template B
Supply Type ☞ Buyer KD Code ☞ Lot No. ☞ Shelf-Life
File Generation
(Sequential No.)
EE--document provided to Suppliersdocument provided to Suppliers
Data template : Receipt template (R02)
Item MODE Description
Template no. an(3)◾ Sent/received template no.
R02: Receipt template
Receipt
No.
Receipt date n(6)◾ KPIS receipt date
- YYMMDD (Year Month Date)
Sequential No. n(8) ◾ Numbers assigned by KPIS
20
Supplier’s business registration no. n(10) State supplier’s business registration number.
Buyer’s business registration no. n(10) State buyer’s business registration number.
Supply type n(1)
◾ State supply type of medical supplies.
1: Ship 2: Return 3: Scrap
- If the existing report needs to be modified or canceled
4: Correct error 5: Cancel
Receipt count n(8) Total receipt count
Receipt amount n(12) Total supply amount received
EE--document provided to Supplier document provided to Supplier
Cover template: Return notice template (R03)
Item MODE Description
Template no. an(3)◾ Sent/received template no.
R03: return notice template
Supplier name an(100) ◾Reported supplier
1
21
Supplier’s business
registration numbern(10) ◾ Business registration number of the reported supplier
Contact (representative) An(20) ◾Name of supplier contact person (representative)
Supply type n(1) ◾ reported supply type of medical supplies
Buyer’s business registration
numbern(10) ◾ reported buyer’s business registration number
EE--document provided to Suppliers document provided to Suppliers Template ‘A’ : Return notice template (R03)
Item MODE Description
Template type n(1) ◾ A / B template type - 1: A 2: B
Sequential number n(6) ◾ reported sequential number of template A
Supplier sales type n(1) ◾ reported supplier sales type
Contract method n(1) ◾ reported contract type
Supply type n(1) ◾ reported supply type
supply purpose n(1) ◾ reported supply purpose
Buyer name an(100) ◾ reported buyer name
Buyer’s business registration number n(10) ◾ reported buyer’s business registration number
2
22
Buyer’s business registration number n(10) ◾ reported buyer’s business registration number
Buyer’s Sanitarium ID n(8) ◾ reported sanitarium ID
Standard code name an(300) ◾ reported standard code name
Standard code n(13) ◾ reported standard code
Total product Qty. n(8) ◾ reported total product Qty.
Supply Qty. n(8) ◾ reported standard code’s supply Qty.
Supply date n(8) ◾ reported supply date
Supply amount n(12) ◾ reported supply amount including VAT
Supply unit price n(10) ◾ reported supply unit price
Receipt no. (requiring update reporting) n(12) ◾ state report receipt number
Return reason code an(12) ◾ return reason code
Serial number type n(1) ◾ reported serial number type
comment an(200) ◾ reported comment
EE--document provide to Suppliers document provide to Suppliers
Template ‘B’ : Return notice template(R03)
Item MODE Description
Template type n(1)◾ A/B template type
- 1: A 2: B
Sequential number n(6) ◾ reported sequential number of template A
Serial number an(20) ◾ reported serial number
3
23
Serial number an(20) ◾ reported serial number
Manufacture no. (Lot) an(20) ◾ reported manufacture no.
Shelf-life n(6) ◾ reported maximum shelf-life (expiration date)
Bundle no. an(200) ◾ reported bundle no.
RFID Tag code an(13) ◾ reported RFID Tag code
EE--document provided to Suppliersdocument provided to Suppliers
Cover template : Medical supply RFID Tag notice template (R04)
Item MODE Description
Template No an(3)◾ Sent/received template number
R04: Medical supply RFID Tag Data notice template
Business registration number n(10) State requestor’s business registration number.
Data template : Medical supplies RFID Tag notice template (R04)
24
Data template : Medical supplies RFID Tag notice template (R04)
Item MODE Description
RFID Tag code n(13) Requested RFIDTagcode
Serial number an(20) Requested serial number
Standard code n(13) Standard code of the medical supply
Manufacture no. (Lot) an(20) Manufacture no. of the medical supply
Maximum shelf-life n(6) Maximum shelf-life of the medical supply (expiration date)
EE--document provided to Suppliersdocument provided to Suppliers
Serialized return report (example)Template
Cover template
Template A
Template B
R03 Hongkilding Pharmaceutical 1122334455 Hongkildong 16677889900
10000011216Shimpyeong Pharmaceutical 667788990099999999 anti-biotics 880123456789033 … … DCDHFHFGDEFI1
200000188012345678901QX987201803310088064111234567891/1880641112345912345 ……200000188012345678902QX987201803310088064111234567891/1880641112345912345 ……200000188012345678903QX987201803310088064111234567891/1880641112345912345 ……
Request return and provide data for 3 Qty. of medical supply 1234567890
25
Medical supply RFID tag notice (example)
Template
Cover template
RFID data request template
S041122334455
08812341123451234567890
Provide data that company 1122334455 requested for RFID Tag 088112345
RFID data provision template
088123411234512345678908801234567890QX98720180331
Cover template R041122334455
Medical Supply Serialization Flowchart Medical Supply Serialization Flowchart
3. Medical Supply Serialization Flowchart 3. Medical Supply Serialization Flowchart
Supply Data Interface Flowchart 0101
RFID Data Request Flowchart0202
27
Portal-driven Supply Data Flowchart 0303
Supply Data Interface Flowchart Supply Data Interface Flowchart
Supplier(Distributor)
KPISBuyer
(distributor)
자체점검
System
Agent(provided by
HIRA)
Generate supply data
Check errors
ErrorY
System
Agent(provided by
HIRA)
Interface system
Agent
Serialization Mgmt. System
5) Checkup request 7) Checkup data1
3
4
5 7
8
2
28
ErrorY
N
Serialization Mgmt. System
DBSystem checkup
6
1 Check errors: documentation proofing (number of digits, preparation rules, etc.), master checkup (unit price error, error, standard code error)
2 Supply data reporting: generating supply data in accordance with e-document rules (by buyer (distributor)) (S01)
3 Receipt: receipt & return notice (R02)
4 Purchasing data: Send purchasing data to buyer (distributor) of supply data reporting (R01).
5 Checkup request: Send supply data to Serialization Mgmt. System.
6 System checkup: Assign receipt no. to supply data, generate return data, and generate supply data history.
7 Checkup data: Send generated receipt and return data to interfaced systems.
8 Return data notice: Send return data, if any, to suppliers (R03).
RFID Data Request FlowchartRFID Data Request Flowchart
Supplier(distributor)
KPIS
자체점검
System
Agent(provided by
HIRA)
Generate RFID Tag
Data request file
Check errors
Error Y
Interface system
Agent
Serialization Mgmt. System
Data search request RFID Tag data1
4
2
29
Error Y
N
Serialization Mgmt. System
DB Data creation3
1 Error checkup: Documentation proofing (number of digits, preparation rules, etc.)
2 Data request: Medical supplies RFID tag data request, in accordance with e-template (S04)
3 Data creation: Serialization Mgmt. System creates RFID tag information and sends it over to interface system.
4 RFID Tag data: Send RFID Tag data to requestors (R04).
PortalPortal--driven Supply Data Flowchartdriven Supply Data Flowchart
Supplier(distributor)
KPISBuyer
(distributor)
Medical supplies supplier portal
System checkupCSV File
CSV File
Error correction & confirmation received
System
Agent(provided by
HIRA)
PC (system)
PC (system)
1
23
4
5
30
1 supply data : checkup request after entering supply data and file upload
2 System checkup : real-time checkup ( documentation proofing & master file checkup )
3 error correction & confirmation : error correction & reason description, re-checkup request, final submission decision
4 Received : receipt processing & purchasing data generation, file transmission through interface system
5 Purchasing data : download purchasing data to buyer (distributor) and transfer file through interface system
Error correction & confirmation received
Agent(provided by
HIRA)
Interface systemAgent
4
5
Thank you!Thank you!
Q & A