E-labelling Guidance and Implementation in

Malaysia

Presentation by:
ROSLIZA LAJIS
National Pharmaceutical Regulatory Agency (NPRA)
Ministry of Health Malaysia
PRESENTATION OUTLINES

E-LABELLING MILESTONES IN MALAYSIA

01 a) Formation of e-labelling task force

b) Survey on industry readiness
c) Results of the survey

E-LABELLING REQUIREMENTS IN MALAYSIA &

02 IMPLEMENTATION DETAILS

RESPONSIBILITIES OF PRODUCT
03 REGISTRATION HOLDERS

04 VOLUNTARY PHASE: TO CONDUCT

E-LABELLING ASSESSMENT
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 E-LABELLING MILESTONES IN MALAYSIA

2023
2022
2021
2019
Formation of Joint Joint Industry Task Force Formation of e-Labelling ▪ Proposal to implement
Industry Task Force proposed e-labelling Task Force consists of e-labelling was
consists of the industry implementation representatives from approved by the
associations: PhAMA, Ministry of Health and Malaysian Drug Control
MOPI and MAPS industrial associations Authority
▪ Voluntary e-labelling has
PhAMA: Pharmaceutical Association of Malaysia been implemented since
1 May 2023
MOPI: The Malaysian Organisation of Pharmaceutical Industries
MAPS: Malaysian Association of Pharmaceutical Suppliers 3
 (1) FORMATION OF E-LABELLING TASK FORCE

Develop policy and requirements

3 of e-labelling

Conduct survey on the industry

readiness for the implementation 2 4 Plan the implementation

Share the knowledge/

Identify the potential issues
and find the solutions 1 5 discuss to facilitate the
implementation

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 (2) SURVEY ON INDUSTRY READINESS

OBJECTIVES OF THE SURVEY:

Anticipate
readiness Preferred
among Scope of hosting
To
the products sites
identify
List of
▪ Conducted in industry reasons
challenges
March – April for not
being
2022 ready
▪ Participated by
78 members of
PhAMA, MOPI
and MAPS 1 3 5

2 4
IDEA 5
 (3) RESULTS OF THE SURVEY

79.5% 82.3% 52.6%

READINESS ON E-LABELLING WHEN DO YOU ANTICIPATE WHAT IS YOUR PREFERRED

IMPLEMENTATION READINESS COULD BE HOSTING SITE?
BY Q3 2022 ATTAINED?
▪ 20.5% ready ▪ 82.3% ready to ▪ 52.6% preferred NPRA
implement between ▪ 43.6% preferred
▪ 79.5% not ready due to: 2023 - 2025
a) The current product label has company/ 3rd party
been printed in a large amount ▪ 17.7% ready to
b) Need more time to re-design label implement by Q3 ▪ 3.8% has no preference
to include QR code 2022
c) Worry about variation approval
time
d) The readiness of the hosting site 6
(3) RESULTS OF THE SURVEY

LIST OF CHALLENGES IDENTIFIED:

1 The need to conduct assessment before implementation

To identify hosting platform that is viable in terms of

2 resources, technical maintenance, accessibility, reliability
and compliance

Limited accessibility in rural areas. Alternative measure

3 is to provide a paper copy should it be required

Changes in URL and QR code will incur cost to the

42 product label & product price

To create awareness among the users on the

5 implementation

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 (4) Concerns
Concerns on limited internet/smartphone usage in some areas or for old
1 populations?
Survey by Malaysian Communications and Multimedia Commission in 2021:
• 122.8% Malaysian population has access to smart phone & 85% has
access to internet
• Limited accessibility in rural areas. Alternative measure is to provide a
paper copy should it be required

Concerns on how to inform the end-users (Healthcare professionals,

2 patients).
Create continuous awareness among the users on the implementation
(industry’s responsibilities). DHCP letter as communication tool.

2
Concerns on how to communicate guidance for end-users to use e-
3 label
• Create a continuous awareness with HCP because patients will be
meeting HCP. HCP will assist to share knowledge during the
consultation session
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E-LABELLING REQUIREMENTS IN MALAYSIA

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 E-LABELLING REQUIREMENTS IN MALAYSIA

E-LABELLING E-LABELLING
DEFINITION FORMAT
The provision of an approved product Shall be presented in a QR code that is
information that includes the package translated to NPRA QUEST3+ system
insert (PI) and/or Consumer which displays the same product
Medication Information Leaflet information in pdf format.
(RiMUP) electronically via a machine
readable QR code on the outer The QR code may be displayed on the
carton/inner label of the product that outer carton or inner label
links to the NPRA QUEST3+ system
The QR code may be printed or affixed
onto the outer carton/inner label using
a stick-on label
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 E-LABELLING REQUIREMENTS IN MALAYSIA
IMPLEMENTATION DATE

Directive of implementation: 11 April 2023

Voluntary starting :
1 May 2023 – 31 December 2026

IMPLEMENTATION SCOPE

Pharmaceutical product for human use

IMPLEMENTATION METHOD
▪ New product: As part of product dossier
▪ Existing product: Minor Variation Notification

GUIDELINE

Guideline on Electronic Labelling (e-Labelling)

for Pharmaceutical Product in Malaysia
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 VOLUNTARY
PRODUCT SCOPE
IMPLEMENTATION

1 Biologic 2023 2026

2 New Drug Product 1 31

May December
3 Generic Product
Containing
Scheduled Poison START END
SLIDESMANIA.COM

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 E-LABELLING IMPLEMENTATIONS IN MALAYSIA

DATA CARRIER: DATA FORMAT: HOSTING SITE:

QR CODE PDF NPRA QUEST SYSTEM

QR CODE SCAN NPRA QUEST SYSTEM PRODUCT

OF THE PRODUCT: INFORMATION FROM
NPRA QUEST SYSTEM:

▪ Product Name
▪ Registration Number
▪ Holder & Address
▪ Manufacturer &
Address
▪ Importer & Address
▪ Ingredient Information
▪ Packaging Information
▪ Consumer Medication
Information Leaflet
SLIDESMANIA.COM

(RiMUP)
▪ Product Label
▪ Package Insert 13
MECHANISM OF E-LABELLING IN MALAYSIA

• E-labelling is defined as the provision of an approved product

information that includes the package insert (PI) and/or Consumer
Medication Information Leaflet (RiMUP) electronically via a machine
readable Quick Response (QR) code on the outer carton/inner label
of the product that links to the NPRA QUEST system
• QUEST3+ system will be used as the hosting site during the
voluntary phase
• When QR code is scanned using smartphones/ laptops/ tablets. the
latest PI and RiMUP in QUEST3+ NPRA will appear
• Product Registration Holder (PRH) may display the QR code on the
outer packaging (e.g. outer carton) of the products or where there is
no outer packaging,2 on the inner label
• PRH should generate QR code that links to product-specific page in
NPRA website

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ACCEPTABLE E-LABELLING FORMATS

• E-labelling shall be presented in a QR code on the

outer carton/inner label of the product that translates to
the online NPRA QUEST3+ page which displays the
same product information in a pdf format.
• The format would allow optimized viewing on any
electronic devices such as smartphones/ laptops/
tablets.
• Product information in video format is currently not
allowed
2
Note: The maximum capacity of product information (e-labelling) to be
uploaded and hosted in QUEST3+ system shall not exceed 5MB

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APPLICATION FOR E-LABELLING

• Variation Type : MiV-N - E-labelling Verification

• D2. Label (mock-up) for Outer Carton
- label with QR code

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ACCESSIBILITY OF E-LABELS

• The approved e-label content shall not be modified by any means. The
product information used shall be approved by Drug Control Authority
(DCA). A partially extracted package insert of DCA-approved product is not
allowed.
• PRH may display the QR code on the outer packaging (e.g. outer carton)
of the products or where there is no outer packaging, on the inner label.
• The QR code may be printed or affixed onto the outer carton/inner label
using a stick-on label. If the stick-on label method is used, the following
criteria should be met:
a) The stick-on label shall not cover any information on the outer carton
or inner label
b) The stick-on label shall be made from good quality materials and is
not easily torn2 or peeled off.
c) This activity shall be carried out in a licensed secondary repacker
facility that complies with Good Manufacturing Practice (GMP)/Good
Distribution Practice (GDP) requirements
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APPROVED PI & E-LABELING

• Readily available online NPRA QUEST3+ page in the NPRA

website
• PRH should generate QR code that links to product-specific
page in NPRA website
• PRH may display the QR code on the outer packaging (e.g.
outer carton) of the products or where there is no outer
packaging, on the inner label

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MECHANISM FOR WEBSITE MAINTENANCE

• Who is responsible? NPRA website (NPRA responsibility)

• PRH’s roles and responsibilities- PRH are responsible for ensuring that
the product information that appears in the QUEST3+ system are aligned
to the most up-to-date PI/RiMUP information as approved. Upon approval
of any label update, the e-labelling should be updated immediately.

• PRH may include proposals for e-labelling in the dossier submission for
new product registrations. The process remain the same as submission
for new product registration

• Changes to current2 approved labels solely to incorporate e-labelling

without any changes to the approved product information may be
submitted as ‘Minor Variation Notification (MiV-N): E-labelling Verification’
using the current variation procedure.

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PAPERLESS CONSIDERATION

• Voluntary basis
• PRH is responsible to issue a Dear Healthcare Provider (DHCP)
Letter as a communication tool in informing healthcare facilities
and healthcare professionals on the use of e-labelling. The
DHCP Letter shall be provided along with printed copies of the
package insert (PI) and/or Consumer Medication Information
Patient Information Leaflet (RiMUP)
• PRH to provide the physical printed copies when it is required

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VOLUNTARY E-LABELLING IMPLEMENTATION

• Proposal to implement e-labelling was approved by the Drug

Control Authority in April 2023
• Products eligible for e-labelling : The implementation of e-labelling
is voluntary and applies to new drug products, biologics and
generic products containing scheduled poisons for human use
only
• Extension of e-labelling to other product categories will need to be
further reviewed
• E-labelling requirements : the use of e-labelling is subjected to
the product labelling requirements as stipulated in the current
edition of the Malaysia
2 Drug Registration Guidance Document
(DRGD). Failure to comply with the requirements of e-labelling
may result in regulatory actions

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 RESPONSIBILITIES OF PRODUCT REGISTRATION HOLDER (1)

BEFORE USING THE E-LABEL

FOR EXISTING PRODUCT

COMMUNICATE WITH Submit variation under category
INDUSTRY ASSOCIATION
BEFORE VARIATION SUBMISSION ‘Minor Variation Notification
(MiV-N): E-labelling Verification’
To ensure e-labelling variation
in a staggered manner
submitted systematically as
agreed by Task Force members

FOR NEW PRODUCT

GENERATE QR CODE
Generate QR code from URL 1) Submit e-labelling application
obtained from NPRA QUEST along with the product dossier.
system relevant to the product 2) Apply variation after product
registration approval

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RESPONSIBILITIES OF PRODUCT REGISTRATION HOLDER (2)

DURING E-LABELLING IMPLEMENTATION

Issue DHCP Letter to healthcare professionals to inform about e-labelling

implementation and hardcopy package insert and/or Consumer Medication
Information Leaflet (RiMUP) is available upon request

Provide hardcopy package insert and/or Consumer Medication Information

Leaflet (RiMUP) required by healthcare professionals

Monitor complaints, feedback and request from healthcare professionals

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RESPONSIBILITIES OF PRODUCT REGISTRATION HOLDER (3)

ASSESS THE ACCEPTANCE OF

E-LABELLING IMPLEMENTATION

To analyse feedback received from the stakeholders

To be conducted:
a) One year after implementation (Interim analysis)
b) Two years after implementation

Identified stakeholders in government and private

facilities setting:
a) Pharmacists
b) Doctors
c) Dentist
d) Nurses

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 E-LABELLING ASSESSMENT

1 To analyse complaints and feedback

received from stakeholders

To be conducted:
2 a) One year after implementation (Interim analysis)
b) Two years after implementation

3 Identified stakeholders:
a) Malaysian Medical Association
b) Malaysian Pharmacist Society
c) Malaysian Nurses Association
d) Pharmacy Practice and Development Division

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BENEFITS & CHALLENGES OF E-LABELLING
Benefits
• Reduced Environmental Impact
• Cost Savings
• Dynamic and Real-Time Information
• Space Savings
• Enhanced Traceability

________________________________________________

Challenges:
• Access to Technology
• Digital Literacy
• Integration with Existing Systems
2
• User experience
• Offline Access

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 FUTURE VISION/NEXT STEPS OF E-LABELING FOR MALAYSIA
• E-labelling assessment: To analyse complaints and feedback received from stakeholders

• E-labeling for future digital health : Exploring Interoperability in e-labeling

- Interoperability of e-labeling refers to the ability of electronic labeling systems to work together seamlessly across
different platforms, devices, and regulatory environments

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THANK YOU
FOR YOUR ATTENTION
03-7883 5400 (General line)
03-7801 5410

rosliza@npra.gov.my

http://www.npra.gov.my

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