Feedback can be received no later than November 5, 2021

1. Input for content material regarding the Drug can be submitted via email
[email protected] or [email protected]

2. Input for content material regarding Traditional Medicine, Quasi Medicine, Supplements
Health, and Cosmetics can be delivered via email [email protected]

3. Input for content material regarding Processed Food can be delivered via email
[email protected]

DESIGN
REGULATIONS OF THE FOOD AND DRUG REGULATORY AGENCY
NUMBER... YEAR 2021
ABOUT
CHANGES TO THE REGULATIONS OF THE FOOD AND DRUG REGULATORY AGENCY
NUMBER 33 OF 2018 ON THE APPLICATION OF 2D BARCODES IN
DRUG AND FOOD CONTROL

WITH THE GRACE OF THE ALMIGHTY GOD

HEAD OF THE FOOD AND DRUG ADMINISTRATION,

Considering: a. that the public needs to be protected from drugs and foods that do not meet
the standards and/or safety requirements, expediency/efficacy, and
quality;

b. that based on the provisions of Article 3 paragraph (1) letter d

of Presidential Regulation No. 80 of 2017 concerning the
Food and Drug Supervisory Agency, the Food and Drug
Supervisory Agency has the function of carrying out
supervisory duties before circulating and supervision during
circulation;

c. that the provisions regarding the Application of 2D Barcodes

in Drug and Food Supervision as stipulated in The Food and
Drug Administration Regulation No. 33 of 2018 concerning
the Application of 2D Barcodes in Drug and Food Supervision
are not in accordance with legal needs so it needs to be
changed;

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 -2-

d. that based on the considerations referred to in letter a, letter b

and letter c, it is necessary to establish the Regulation of the
Food and Drug Supervisory Agency on Changes to the
Regulation of the Food and Drug Supervisory Agency No. 33
of 2018 on the Application of 2D Barcodes in Drug and Food
Supervision;

Remember: 1. Presidential Regulation No. 80 of 2017 concerning the Food and Drug
Supervisory Agency (State Gazette of the Republic of Indonesia
year 2017 Number 180);
2. Regulation of the Food and Drug Supervisory Agency No. 33
of 2018 on the Application of 2D Barcodes in Drug and Food
Supervision (State News of the Republic of Indonesia Year
2018 Number 1599);
3. Regulation of the Food and Drug Supervisory Agency No. 21
of 2020 concerning the Organization and Working
Procedures of the Food and Drug Supervisory Agency (State
News of the Republic of Indonesia Year 2020 Number 1002);
4. Regulation of the Food and Drug Supervisory Agency No. 22
of 2020 concerning the Organization and Working
Procedures of technical implementation units in the
Environment of the Food and Supervisory Agency (State
News of the Republic of Indonesia Year 2020 Number 1003);

DECIDE:
Set: REGULATION OF THE FOOD AND DRUG REGULATORY
AGENCY ON CHANGES TO THE REGULATION OF THE FOOD
AND DRUG REGULATORY AGENCY NO. 33 OF 2018 ON THE
APPLICATION OF 2D BARCODES IN DRUG AND FOOD
SUPERVISION.

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Article I
Some provisions in the Regulation of the Food and Drug
Supervisory Agency No. 33 of 2018 on the Application of 2D
Barcodes in Drug and Food Supervision (State News of the
Republic of Indonesia Year 2018 Number 1599) were changed as
follows:

1. The provisions of Article 1 are amended so that Article 1

reads as follows:

Article 1
In this Agency Regulations it is referred to by:
1. A 2D barcode is a graphical representation of digital
data in a high-capacity two-dimensional format that can
be read by optical tools used for identification, tracking,
and tracking.

2. Authentication is a method of tracing and verifying the

legality, batch number, expiration, and/or serial number
of Drug and Food products.
3. Identification is a method of verifying the legality of Drug
and Food based On The License.
4. Medicine is a finished drug including a biological
product, which is an ingredient or alloy of ingredients
used to affect or investigate a physiological system or
pathological state in order to establish diagnosis,
prevention, healing, recovery and improvement of health
and contraception for humans.

5. Traditional Medicine is an ingredient or herb in the form

of plant ingredients, animal materials, mineral
ingredients, sarian preparations (galenik),

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 -4-

or a mixture of such materials that have been used for

generations for treatment, and can be applied in
accordance with the norms that apply in the community.
6. Quasi-drugs are preparations that contain active
ingredients with pharmacological effects that are non-
systemic or local and to address mild complaints.

7. Health supplements are products intended to

complement nutritional needs, maintain, improve and/or
improve health function, have nutritional value and/or
physiological effects, contain one or more ingredients in
the form of vitamins, minerals, amino acids and/or other
non-plant ingredients that can be combined with plants.

8. Cosmetics are ingredients or preparations intended for

use on the outside of the human body such as the
epidermis, hair, nails, lips and outer genital organs or
teeth and mucous membranes of the mouth especially
for
Cleanse, smell, change appearance and/or improve
body odor or protect or maintain the body in good
condition.

9. Processed foods are foods or beverages processed in

certain ways or methods with or without additives.
10. Processed Foods for Special Diets, hereinafter referred
to as Special Diet Foods, are Processed Foods that are
processed or specially formulated to meet nutritional
needs.

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Certain physical or physiological conditions.

11. The Food and Drug Administration's Track and Trace

Application, hereinafter referred to as the POM Agency's
Track and Trace Application, is an application to issue
2D Barcodes and/or record each product transfer so that
product information can be obtained and product
location, both current location and history of the location
of the unique product movement.

12. Quick Response Code, hereinafter referred to as QR

Code, is a two-dimensional code (2D Barcode)
consisting of a marker of three square patterns at the
bottom left corner, upper left corner, and upper right
corner, having a black module (square)
dots/pixels), and has the ability to store alphanumeric
data, characters, and symbols.

13. Business Actor is any individual or business entity,

whether in the form of a legal entity or not a legal entity,
which is established and domiciled or conduct activities
within the jurisdiction of the Republic of Indonesia, either
alone or together through an agreement to organize
business activities in the field of Medicine and food.

14. The Pharmaceutical Industry is a business entity that

has a permit in accordance with the provisions of the
laws and regulations to carry out activities to make drugs
or drug ingredients.
15. Distribution facilities are facilities that
used to distribute or

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drug traffickers, namely pharmaceutical wholesalers and

government pharmaceutical installations.
16. Pharmaceutical Services Facility is a means used to
organize pharmaceutical services, namely pharmacies,
hospital pharmacy installations, clinic pharmacy
installations, health centers, and drug stores.

17. Edar permit is a form of approval for registration of

Drugs, Traditional Medicine, Quasi-Medicine, Health
Supplements and Processed Foods or cosmetic
notification form has been notified, a form of notification
of fulfillment of processed food commitments and a form
of approval of processed food to be distributed in the
territory of Indonesia.

18. Primary packaging is packaging that intersects directly

with medicine and food.

19. Secondary packaging is packaging that protects primary

packaging.
20. Tertiary packaging is packaging used to combine the
entire Secondary Packaging to facilitate the
transportation process and prevent product damage.
21. The Food and Drug Administration which is hereinafter
referred to as the POM Agency is an agency.
non-ministry government that organizes government
affairs in the field of drug and food supervision.
22. The head of the agency is the head of the Food and
Drug Administration.
23. The day is a working day.

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2. The provisions of paragraph (2) of Article 2 are amended so

that Article 2 reads as follows:
Article 2
( 1 ) The application of 2D Barcodes as stipulated in the
Regulation of this Agency covers drugs and food
produced and distributed in the country and / or
imported for distribution in the territory of Indonesia.

( 2 ) Medicine and food as referred to in paragraph (1)

consist of:
a. Medicine;
b. Traditional medicine;
c. Quasi Medicine;
d. Health Supplements;
e. Cosmetics; and
f. Processed Food.

3. The provisions of paragraph (2) letter b are removed and

paragraph (3) Article 3 is amended and between paragraph
(3) and paragraph (4) inserted 2 (two) verses, namely
paragraph (3a) and paragraph (3b) and paragraph (4) and
paragraph (5) are removed so that Article 3 reads as follows:

Article 3
(1)2D Barcode as referred to in Article 2 using the method of:

a. Authentication; and
b. Identification.
(2)2D Barcode with authentication method as referred to in
paragraph (1) letter a applies to drugs that belong to the
group:

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 -8-

a. Hard drugs, including biological products;

b. removed;
c. narcotics; and
d. Psychotropic.
(3)2D Barcode with identification method as referred to in
paragraph (1) letter b applies to:

a. Drugs that belong to the class of over-the-counter

drugs and limited over-the-counter drugs;
b. Traditional medicine;
c. Quasi Medicine;
d. Health Supplements;
e. Cosmetics; and
f. Processed Food.
(3a) Processed Food as referred to in the paragraph
(3) the letter f includes Special Food Diet.
(3b) Excluded from the provisions of Authentication as
referred to in paragraph (2), for hard drugs that include
radiopharmaceutics and contrast media shall apply 2D
Barcode with identification methods.

(4) removed.
(5) removed.

4. Between Article 5 and Article 6 inserted 1 (one) Article,

namely Article 5A so that it reads as follows:

Article 5A
Pharmaceutical Industry that implements 2D Barcode with
Authentication method must apply aggregation system.

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5. The provisions of paragraph (1) of Article 7 are amended and

added 2 (two) paragraphs namely paragraph (3), and
paragraph (4), so that Article 7 reads as follows:

Article 7
(1) 2D Barcode as referred to in Article 5 paragraph (1) letter
a is issued based on the application of Business Actors
submitted online through the Pom Agency Track and
Trace Application.

(2) The application for the issuance of 2D Barcode as

referred to in paragraph (1) is submitted by the Business
Actor who owns the Edar Permit.
(3) To be able to apply for the issuance of 2D Barcode as
referred to in paragraph (1), business actors must have
access rights registered in the POM Agency's Track and
Trace Application.

(4) To obtain the access rights registered as referred to in

paragraph (3), the Business Actor must fill out the
registration form on the POM Agency Track and Trace
Application to obtain a username and password.

6. The provisions of paragraph (1) of Article 10 are amended, so

that Article 10 reads as follows:

Article 10
(1) 2D Barcode as referred to in Article 7 paragraph (1) is
issued electronically no later than 5 (five) Days from the
date of application.
(2) 2D Barcode as referred to in paragraph (1)

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only applies to bets or proposed production codes.

7. The provisions of Article 11 were amended so that they read

as follows:

Article 11
(1) Business Actors who manage Drugs with 2D Barcodes and
have implemented authentication methods must submit a
2D Barcode report to the POM Agency.

(2) Pharmaceutical Distribution Facilities and Facilities that

manage Drugs at least 1600 (one thousand six hundred)
drug products that have been
Applying the Authentication method is required to submit a
2D Barcode report to the POM Agency.

8. The provisions of paragraph (1), paragraph (2), and

paragraph (3) of Article 12 are amended, so that Article 12
reads as follows:

Article 12
(1) The report as referred to in Article 11 submitted by the
Business Actors of the owner of the Edar Permit in the
form of a report on the use of 2D Barcode.
(2) Reports on the use of 2D Barcodes as referred to in
paragraph (1) include:
a. 2D Activated Barcode;
b. 2D Barcode distributed; and
c. 2D Barcodes listed on recall or return products.
(3) In addition to the report referred to in paragraph (2),

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Business Actors who are the Pharmaceutical Industry

must submit aggregation code information.
(4) The aggregation code referred to in paragraph (3)
includes:
a. primary code;
b. secondary code; and
c. tertiary code.
(5) The report as referred to in paragraph (2) and paragraph
(3), is submitted through the Pom Agency Track and Trace
Application no later than 24 (twenty-four) hours at each
activity as referred to in paragraph (2).

9. The provisions of paragraph (1) of Article 13 were amended

and paragraph (4) were removed so that Article 13 reads as
follows:

Article 13
(1) Submission of 2D Barcode report by Drug Distribution
Facility and Pharmaceutical Service Facility as referred to
in Article 11 paragraph (2) must be submitted through the
Pom Agency Track and Trace Application.

(2) The report referred to in paragraph (1) includes:

a. all products received;

b. all products distributed; and
c. all products recalled or returned.

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(3) Submission of the report as referred to in paragraph (2) is

submitted through the Pom Agency Track and Trace
Application for a maximum of 24 (twenty-four) hours in
each activity as referred to in paragraph (2).

(4) Deleted.

10. The provisions of Article 15 were amended, so that they read

as follows:

Article 15
2D Barcode as referred to in Article 14 contains information
about Edar Permit.

11. The provisions of paragraph (1) of Article 17 were amended

and added 2 (two) paragraphs namely paragraph (3) and
paragraph (4), so that Article
17 reads as follows:

Article 17
(1) 2D Barcode as referred to in Article 3 is printed on the
packaging with a different ink color with the base color.
(2) 2D Barcode as referred to in paragraph (1) should be
easily scanned and readable by the BPOM Mobile
application.
(3) Excluded from the provisions referred to in paragraph (1),
for Traditional Medicine, Quasi Medicine, Health
Supplements, Cosmetics, and Processed Food 2D
Barcode can be printed in the form of stickers whose
inclusion is glued to the packaging with a different ink color
with the base color.

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(4) The inclusion of 2D Barcode as referred to in paragraph

(1) and paragraph (3) is done in such a way that it is not
easily separated or separated from the packaging and is
not easily worn or damaged.

12. The provisions of paragraph (2) of Article 18 are amended

and added 1 (one) paragraph i.e. paragraph (4), so that
Article 18 reads as follows:

Article 18
(1) The Pharmaceutical Industry owner of the Drug License as
referred to in Article 3 paragraph (2) shall include a 2D
Barcode with authentication method on the packaging as
mentioned in the approval of the Drug Circular Permit.
(2) In the case of circular packaging as referred to in
paragraph (1) in the form of Secondary Packaging or
Tertiary Packaging must be with safeguards to ensure the
authenticity of the contents of the Drug.
(3) Pharmaceutical Industry owner of Drug License as
referred to in Article 3 paragraph (3) letter
a It is mandatory to include a 2D Barcode with
identification method on the Primary Packaging.
(4) Obligation to include 2D Barcode on Primary Packaging
as referred to in paragraph
(3) excluded for Drugs with the following conditions:
a. single packaging;
b. volume below 10 mL (ten milliliters);
c. Blister Primer Packaging;
d. Primary strip packaging; or
e. tube packaging.

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(5) 2D Barcode as referred to in paragraph (4) can be listed

on secondary packaging with safeguards to ensure the
authenticity of the contents of the drug.

(6) Safety as referred to in paragraph (2) and paragraph (5) if

tampered with results in damaging packaging.

13. The provisions of Article 19 were amended, so that Article 19

reads as follows:

Article 19
( 1 ) Traditional Medicine, Quasi Medicine, and Health
Supplements owners of Edar Permits must include 2D
Barcodes on Primary Packaging.

( 2 ) The obligation to include 2D Barcode on Primary

Packaging as referred to in paragraph (1) is excluded
for Traditional Medicine, Quasi Medicine and Health
Supplements by listing on Secondary Packaging with
the following provisions:
a. single packaging;
b. volume below 10 mL (ten milliliters);
c. Blister Primer Packaging;
d. Primary strip packaging;
e. ampoules packaging;
f. tube packaging;
g. stick pack;
h. Primary packaging suppositories; or
i. have a label surface area of less than

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or equal to 10 cm2 (ten square centimeters).

14. The provisions of Article 22 were amended, thus reading as

follows:

Article 22
Business Actors must list a 2D Barcode with a rectangular
shape with a size of at least 0.6 x 0.6 cm (zero comma six
times zero six centimeter com).

15. The provisions of Article 23 were amended, so that Article 23

reads as follows:

Article 23
Business Actors must include the inscription "BPOM RI" on
the 2D Barcode issued by the POM Agency on the
packaging of drug and food products.

16. The provisions of letter c of Article 25 are removed, so Article

25 reads as follows:

Article 25
The BPOM Mobile application as referred to in Article 24
contains at least the following information:

a. product name;
b. Edar Permission number;
c. removed;
d. name and address of business actors; and
e. Packaging.

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17. The provisions of Article 26 were amended, so that Article 26

reads as follows:

Article 26
(1) Violation of the provisions of Article 3 paragraph (3a),
Article 5A, Article 11, Article 12 paragraph (3), Article 13
paragraph
(1), Article 16, Article 18 paragraph (1), Article 19
paragraph (1), Article 20 paragraph (1), Article 21
paragraph (1), Article 21 paragraph
(2), Article 21 paragraph (4), Article 22, and/or Article 23
paragraph (1) are subject to administrative sanctions in
accordance with the provisions of the laws and
regulations in the field of labeling or marking.
(2) Administrative sanctions referred to in paragraph (1) are
imposed by the Head of the Agency.

18. The provisions of Article 27 were amended, so that Article 27

reads as follows:

Article 27
At the time the Regulations of this Body came into force:
a. Pharmaceutical Industry owners of Edar Permits must
apply 2D Barcode in the form of Authentication no later
than 4 (four) years from the issuance of Edar Permit
electronically after the Regulation of this Agency is
promulgated.

b. The Pharmaceutical Industry, which owns the Drug

License as referred to in Article 3 paragraph (2) shall
apply a 2D Barcode in the form of Authentication no
later than 9 (nine) years since the Regulation of this
Agency was promulgated.
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19. The provisions of Article 28 were amended, so that Article 28

reads as follows:

Article 28
At the time the Regulations of this Body came into force:
a. Pharmaceutical Industry, Traditional Medicine Business
Actors, Quasi Drug Business Actors, Health
Supplement Business Actors, Cosmetic Business
Actors, or Food Business Actors who own Edar Permits
must apply 2D Barcode in the form of Identification no
later than 12 (twelve) months from the issuance of Edar
Permit electronically after this Agency Regulation is
promulgated.

b. Business Actors who own Edar Permits for Over-the-

counter Drug Class Drugs, Limited Over-the-Counter
Medicine, Traditional Medicine, Quasi-Medicine, Health
Supplements, Cosmetics, and Processed Foods in
circulation must apply 2D Barcode in the form of
Identification no later than 5 (five) years from the date
this Agency Regulation was promulgated.

20. Some provisions on the technical instructions for the

application of 2D Barcode in the Annex to The Regulation of
the Food and Drug Supervisory Agency Number 33 of 2018
on the Application of 2D Barcodes in Drug and Food
Supervision (State News of the Republic of Indonesia Year
2018 Number 1599), were amended so that it reads as stated
in the Annex which is an integral part of the Regulation of this
Agency.

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Article II
1. Pharmaceutical Industry that has implemented 2D Barcode
with Authentication method must apply aggregation system
no longer than 1 (one) year from the date of the Regulation
of this Body was promulgated.

2. 2D Barcode with identification method that has been issued

before the enactment of this Agency Regulation is stated to
still remain valid until the new 2D Barcode is issued based on
re-registration by the POM Agency.

3. The agency's regulations come into effect on the date of

promulgment.

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In order for everyone to know him, order

the promulgation of this Agency Regulation with its placement in
the State News of the Republic of Indonesia.

Set in Jakarta
on the date

HEAD OF THE FOOD AND DRUG ADMINISTRATION,

PENNY K. LUKITO

Promulgated in Jakarta
on the date

DIRECTOR GENERAL
LAWS AND REGULATIONS
MINISTRY OF LAW AND HUMAN RIGHTS
REPUBLIC OF INDONESIA

BENNY RIYANTO

STATE NEWS OF THE REPUBLIC OF INDONESIA IN 2021 NUMBER

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ATTACHMENT
REGULATIONS OF THE FOOD AND DRUG REGULATORY
AGENCY
NUMBER... YEAR 2021
ABOUT
CHANGES TO REGULATORY BODY REGULATIONS
DRUGSDANMAKANNOMOR332018

ABOUT THEAPAN2DBARCODEDALAM

DRUG AND FOOD CONTROL

TECHNICAL INSTRUCTIONS FOR THE IMPLEMENTATION OF 2D

BARCODES

A. GENERAL EXPLANATION
The Pom Agency Track and Trace Application (www.ttac.pom.go.id) serves to
facilitate activities on Business Actors who own Edar Permits, distribution
facilities, and pharmaceutical service facilities as follows:
1) Request for access rights;
2) Barcode issuance; and
3) Reporting consists of:
a. Reporting of receipts and expenditures of products;
b. Reporting of distribution (sales) of products;
c. Reporting returns (returns); and
d. Reporting recalls.
The Pom Agency's Track and Trace application is also available in the form of a
Mobile application called BPOM Mobile. Bpom Mobile application facilitates
activities in Business Actors who own Edar Permits, distribution facilities,
pharmaceutical service facilities, and the community as follows:
1) Reporting in accordance with Article 12 and Article 13 of the Regulations of
this Body, includes:
a) Receipt and production of products;
b) Reporting of distribution (sales) of products;
c) Reporting of returned products (returns); and
d) Reporting of recalled products.
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2) In society, it includes:
a) Showing the latest news related to drug and food surveillance;

b) Verify registered products through 2D Barcode scanning;

c) Verify the registered product through check the registration number,
product name or manufacturer's name;
d) Displays the POM Body application link; and
e) Complaint.
Business Actors who use Edar Permits who apply 2D Barcode Identification do
not need to request access rights and reporting through the POM Agency's
Track and Trace application.

B. ACCESS RIGHTS REQUEST

Business Actors who own Edar Permits, distribution facilities, and pharmaceutical
service facilities apply for access rights to pom agency. In the submission, the
facility must attach an official document from the facility that includes information
that corresponds to the data in the ElectronicAlly Integrated Licensing Service
(Online Single Submission / OSS), as follows:
1) The name of the facility based on a Trade Business License (SIUP) or
Importer Identification Number (API) or Attempted Parent Number (NIB);

2) Facility address based on SIUP or API or NIB;

3) NPWP number;
4) The name of the person in charge of the account;
5) The phone number of the person in charge of the account;
6) Email address; and
7) Supporting documents (e.g. SIUP documents, APIs, and NIBs). Requests for
access rights are addressed to the Directorate of Supervision of related
products in POM Agencies or through the POM Agency Track and Trace
Application (www.ttac.pom.go.id/register).

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C. 2D BARCODE
1) 2D Barcode Identification
In the Electronic Edar Permission will be issued a 2D Barcode consisting of
information:
(90) XXXXXXXXXXXX
Description:
Code Information Sum Data format
character
According to
(90) XXXXXXXXXXXX (90) followed Maximum of 16 NIE
Permission
Number (alphanumeric) product
Product Circular
2D Barcode listed on the packaging must be in accordance with the 2D
Barcode contained in the Circular Permit electronically and can be scanned
bpom mobile application

2) 2D Barcode Authentication
a. 2D Barcode Authentication generated by the Pom Agency Track and Trace
Application at the request of business actors is in the form of information
that can then be converted into 2D Barcode.
b. The minimum information on the 2D Barcode is as follows.
(90)
XXXXXXXXXXXX(10)WWWWWW(17)VVVVVV(21)YYYYYYYYYYYYYY
YYYY; or
(01)
XXXXXXXXXXXX(10)WWWWWW(17)VVVVVV(21)YYYYYYYYYYYYYY
YYYY.
Code Information Sum Data format
character
(90) XXXXXXXXXX (90) followed Maximum of 16 According to NIE
Permission
XX Number (alphanumeric) product.
Product
circulation. .
(10) WWWWWW (10) followed 1-20 Appropriate
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number bets (alphanumeric) no.bets/lots

Or lots. product
(17) VVVVVV (17) followed Maximum of 6 YYMMDD
end of time (numeric) (Years-
expired Date)
product
(21)
YYYYYYYYYYYYY (21) followed 1-20 1) If 2D
YYYY number (alphanumeric) Barcode
serialization Generated
product. Track app
and Trace
POM body:
Serialization will
be
produced by
Body application
POM.
2) If 2D
Barcode
produced by
Business Actors
independently
Serialization
follow
the policy
Business Actors
Set.

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01)XXXXXXXXXXX (1) Followed 14 (numeric) Produced by

X International 3rd party
product identity through
is global trade membership.
item number
(GTIN).

c. Information as referred to in letter b can be sorted according to the needs of

business actors who own the license.
d. 2D Barcodes listed on the packaging must match the 2D Barcode reported
to the POM Agency.
e. 2D Barcodes generated by the POM Agency's Track and Trace Application
include primary, secondary and tertiary codes.
 The primary code is the first level code printed on the packaging.

 Secondary code is a second level code that contains information from

several primary codes.
 Tertiary code is a third level code that contains information from several
secondary codes.
f. Furthermore primary, secondary, and tertiary codes can be used to produce
aggregation systems. Aggregation system is a code-giving system that
contains product detail information that is in the primary code listed in the
secondary code while the product details in the primary code and the
secondary code are listed in the Tertiary Packaging.

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3) The inclusion of 2D Barcodes must be equipped with the inscription "BPOM RI"
placed adjacent to the 2D Barcode (below, next to or above) as the example
below:

BPOM RIBPOM RI

or

Figure 1. 2D Barcode on packaging

(example of placement at the top of a 2D Barcode)

D. BARCODE 2D IMPLEMENTATION FLOW – IDENTIFICATION

Figure 2. Barcode 2D Implementation Flow - Identification

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E. BARCODE 2D IMPLEMENTATION FLOW – POM BODY

AUTHENTICATION

Production Facilities or Distribution Facilities Service Facilities

Owner of Edar Permit Pharmaceuticals

Figure 3. Barcode 2D Implementation Flow – Authentication

Image caption 3. Barcode 2D Implementation Flow – Authentication

Product distribution flow

Reporting flow of each facility, reporting details according to the table
below
FIRE Application Programme Interface

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Activities at each facility, as follows:

Production Facilities or Service Facilities
Distribution Facilities Pharmaceutic
Owner of Edar Permit als
1. Publishing Barcode 1. Reporting 1. Reporting
through Acceptance Product Product Acceptance
a. Request from facilities product from product facilities
Publishing (Media Reporting: (Media Reporting:
BPOM Mobile
to Body application, application BPOM
FIR
POM through E and Upload Mobile FIRE and
Track and App Document Reporting Upload Document
Trace Body through Application Reporting through
POM, or; POM body). Track app and
b. Publishing Trace Pom Agency).
self-
sufficient by
Perp Effort
follow
Conditions
regulation
legislation-
invitation.
2. Reporting 2. Reporting 2. Sales Reporting
Use Barcode Product Production Product
(Media reporting: (Media Reporting: (Media Reporting:
FIRE and Upload application BPOM application BPOM
FIR
Reporting documents Mobile E and Mobile FIRE and
through the Track App Upload Document Upload Document
and Trace Body Reporting through Reporting through
POM). Track and App Track app and
Trace Pom Agency). Trace Pom Agency).
Results of Echelon Meeting I August 27, 2021_September 22, 2021
 -28-

Production Facilities or Service Facilities

Distribution Facilities
Owner of Edar Permit Pharmaceuticals
3. Product Expenditure
Reporting (Media
reporting:
BPOM Mobile
applications, APIs and
Upload Reporting
documents through
the POM Agency's
Track and Trace
Application).

1) The application programme interface (API) data type format is JSON.

2) The format of reporting documents can be obtained on the dashboard of

the user application (user).
3) BPOM Mobile application can be downloaded on the play store or apps
store, login using username (username) and password obtained from
BPOM.
4) Manual or Reporting Guidelines will be a separate document from
technical instructions to be obtained in the POM Agency Track and
Trace Application (www.ttac.pom.go.id).

Results of Echelon Meeting I August 27, 2021_September 22, 2021

 -29-

F. COMMUNITY
1. 2D Barcode Verification by The Community

Figure 4. 2D Barcode Scanning by The Community

Image caption 4. 2D Barcode Scanning by The Community

1) People login to the BPOM Mobile application.
2) People choose the Product Check menu.
3) The public performs 2D Barcode scans.

Results of Echelon Meeting I August 27, 2021_September 22, 2021

 -30-

4) The POM Agency's Track and Trace application verifies 2D Barcode

data.
a) If the 2D Barcode data is invalid, the public inputs the product NIE
data. If the NIE data is invalid then the public makes a complaint,
according to the technical instructions of the complaint by the
community.

b) If the 2D Barcode data is valid, it is forwarded to number 5 (five).

5) The public receives at least the following information:

a) product name;
b) Edar Permission number;
c) name and address of business actors; and
d) Packaging.
6) The process is complete.

Results of Echelon Meeting I August 27, 2021_September 22, 2021

 -31-

2. Complaints through BPOM Mobile Application

This flow describes the process of complaints of the most vulnerable
products received by the community.

Figure 5. Complaints by the Community

Picture caption 5. Complaints by the community:

1) People login to the BPOM Mobile application.
2) People choose the Complaints menu.
3) The public makes a complaint by filling out the complaint form in the
Mobile application. The data filled in is:
a) question;
b) product name;
c) bets number;

Results of Echelon Meeting I August 27, 2021_September 22, 2021

 -32-

d) product license number;

e) Supporting photos;
f) location of purchase; and
g) purchase address.
4) The complaint data sent will be stored in the database.
5) The mobile app will provide feedback.
6) The public will get information that can be seen through the Mobile
application.
7) The process is complete.

HEAD OF THE FOOD AND DRUG ADMINISTRATION,

PENNY K. LUKITO.

Results of Echelon Meeting I August 27, 2021_September 22, 2021