Pharmaceutical Serialization Data Interface · Interfacesystem Medical Supply Mgmt. System...

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


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


DBFile to DB

Repository


…

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


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’


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)


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)


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


Template ‘B’ : Serialization report template (S01)


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


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


Cover template : Medical supply RFID Tag request template (S04)


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


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.)


Data template : Receipt template (R02)


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)


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)


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)


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


Cover template : Medical supply RFID Tag notice template (R04)


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)


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)


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


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


Data search request RFID Tag data1

4

2

29

Error Y

N


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

Date post:	20-Sep-2020
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