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High Level Example Who will be impacted

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tio
ta

What is IDMP?

en
within the organization?

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Data

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pl
m
Structure
IDMP ISO 11615 ISO 11239 ISO 11616

i
Compliance for IDMP primarily lies with 2 departments

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O & regiona
Data model with
Medicinal Product Pharmaceutical Product
Identification of attributes that define
Regulatory Affairs Safety consumes the IDMP
and detail a medicinal

dard
Packaging Type
Medicinal Products product and supporting
submits and owns product product identifiers
Bottle Oral information as defined in IDMP Regulatory ICH-E2B(R3) standard makes clear use of

s tan
concepts

sa ing IS
Data Elements and Structures of Route of Admin Capsules There is a legally binding deadline for product identifiers from the IDMP standard.
For unique identification 12 capsules IDMP Submission in EU Optional today but need to ensure step 1

ng
consisting of

t
RA responsible for regulatory compliance to EMA happens and your internal processes &
and exchange

r
Pharmaceutical

gi
po
p Dose Form Paracetamol Information might be sourced from multiple systems are ready for step 2 and 3
su Safety

es
departments manufacturing, R&D, clinical, safety,
ith
s, w HL7
m Unique Unit of 200
ard
5 EN/ISO in
ternational st
a nd
sa
n d
Identifiers
Presentation mg
Step 1
line per Capsule
guide Submission of
Medicinal
Definition and guidelines Product Data
on unique identifiers of the Regulatory 1

Exchange Solution
Internet
Messaging Business Rules and medicinal product and

EDI Gateway
Messaging specifications
ISO 11240
XEVMPD
Format using HL7 for electronic
supporting concepts ISO 11238 UDI

exchange of medicinal Unit of Measurement Substance Step 2 IDMP IDMP

product information Paracetamol, Exchange of Solutions 2 Ack.

IDs with Safety


Chemical substance,
USP grade,
Safety 3
The IDMP Documents
Manufactured in XYZ Internet
ICSR

Components of an Authorized Medicinal Product


Step 3 Ack.

Submission of ICSR

Agency IDMP on the basis of


Implementation Guidelines versioned regulatory

ArisGlobal Solution for IDMP Compliance


ISO IDMP ISO IDMP documents
Standards Technical Specification
User Guidance
ISO 11615
Medicinal Product Info & ID
20443
(MPID) authorized by
agIDMP and agXchange RSM
Examples an agency in a country
ISO 11616
Pharmaceutical Product Info & IDs
20451
(PhPID) Authorities 2 agIDMP
1. IDMP Data Collection

ISO 11615 3 via Interfaces


FAQs 2. Manual data entry for
ISO 11238 19844 A Packaged Product for use against IDMP Data Collection, Manual Entry and Validation
missing info using agIDMP
Substance Info and ID (Substances) Authorized Medicinal Product approved indications
Account Registration 3. IDMP Data Review & QC
ISO 11239 and Maintenance Processes
4 using agIDMP
Controlled Vocabulary 20440 IDMP Data 4. Electronic submission
(DF, RoA, Packaging Terms) (DF/RoA) to be agXchange
to authorities using
manufactured RSM Web Services
agXchange RSM
ISO 11240 14872 And sold as approved eSubmission
Units of Measurement (IDMP Maintenance) HL7 Messaging Standard with approved for IDMP
trade names Data Mapping and Exchange Interfaces 1
(OOTB for Register, Custom for others)

The ISO IDMP Standards Contributors and Consumers of IDMP Data

Group of 5 standards
6 3 Regulatory Safety Clinical Mfg Supply Chain

Medicinal Product Medicinal Version


(MPID) Product Name
Non-Digitized Data
ISO 11615
Register ARISg agClinical

4 5 or others or others or others (Paper or Electronic Form)

Clinical Manufacturing /
ISO 11616
Benefits of IDMP
Pharmaceutical Product Particulars Establishment
(PhPID) Medicinal
Substance, Units Of Product
ISO 11238 Improves the accuracy Provides major human
Specified Measurement Marketing of the evaluation and financial savings for
Substance Pharmaceutical and comparison of the life sciences industry
Product Authorization medicinal by avoiding regional
Dose Form product-related data administration and

ISO 11239
Route of Admin
Unit of Presentation
2 information across
the regions,
investing in a single
set of processes
especially and systems that
Packaging Achieves consistency in
Packaged in the context of cater to these Improves efficiencies of
the use of terminology in
Medicinal pharmacovigilance global data needs information exchange
Substances the health care community
Product
ISO 11240
1 www.arisglobal.com
Each Standard defines data elements and structures for unique identification
and exchange of a certain aspect of a medicinal product
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