Global serialisation requirements – a crucial factor in application selection

Knowledge of the national serialisation regulations in relation to future marketing in the related target markets is perhaps the most important criterion in the definition of the optimal Track & Trace solution. A large number of global projects have shown us that it is especially in this context that planning mistakes are made that can often only be corrected with high expenditure and a large amount of time.

As a starting point our serialisation experts have collected for you all relevant data such as national regulations, underlying coding requirements, timings and evaluations of the market situations in relation to future developments.

You will find all this information in interactive form and simply structured on the TQS map. Simply click on a country and you will receive all the relevant data: complexity reduced to the essential.

Of course, we would be pleased to answer any further questions, irrespective of whether the issue is country-specific planning or a specific project. Send us an e-mail e-mail and a Track & Trace expert will contact you without delay.

TQS infographic: All global serialisation requireemnts at a glance - compact and comprehensible

Download the infographic now!

European Union
Regulation Name / Authority

Directive 2011/62/EU / EU Commission

Serialisation Serialisation
Deadline

February 09, 2019

Data Carrier

Data Matrix ECC200

Data Elements

Unique product identification number (e.g. GTIN/NTIN/PPN), Batch/Lot number, Expiry date, Serial number, National reimbursement number (if applicable).

Tamper Evident

Yes

Aggregation Aggregation
Deadline

Not mandatory

Expert View

Even if the European Falsified Medicine Directive (FMD) is an end-to-end system, the wholesalers and hospital pharmacies will claim for aggregation. This will allow the wholesaler to easily meet the risk-based verification approach if cases or even pallets of the related products are not directly supplied from a manufacturing or marketing authorization holder (or a person supplying on their behalf) and if the product is returned by another wholesale distributor or a pharmacy. Aggregation will also allow the hospital pharmacies to easily decommission their incoming shipments in cases or even pallets.

Austria
Regulation Name / Authority

Coding rules for Austria to be used for verifiable medicinal products on the Austrian market according to EU Directive 2011/62 / EU and Delegated Regulation (EU) 2016/16 / AMVO

Serialisation Serialisation
Deadline

February 9, 2019

Data Carrier

2D Data matrix code with human readable text elements

Data Elements

  • Product Code (GTIN or NTIN) (Al 01)
  • Serial Number (AI 21)
  • Batch/Lot Number (AI 10)
  • Expiration Date (AI 17)

Tamper Evident

no

Expert View

NTIN: For medicines marketable in Austria
GTIN: For multi-market packages that are marketable in Austria (which in a specific presentation are marketable in several countries).

Belgium
Regulation Name / Authority

APB (Belgian Pharmaceutical Association) / Belgian MoH

Serialisation Serialisation
Deadline

February 09, 2025

Data Carrier

Data Matrix ECC200

Data Elements

Unique product identification number (e.g. GTIN/NTIN), Batch/Lot number, Expiry date, Serial number, National reimbursement number (if applicable)

Expert View

Belgium should comply with EU FMD serialisation requirements Feb 09, 2025.

Denmark
Regulation Name / Authority

Danish Medicines Agency (DKMA)

Serialisation Serialisation
Deadline

February 9, 2019

Data Carrier

Linear barcode / 2D Data Matrix

Data Elements

  • GTIN and / or unique NTIN
  • Serial Number (AI 21)
  • Batch/Lot Number (AI 10)
  • Expiration Date (AI 17)

Tamper Evident

yes

Expert View

The use of NTINs will diminish after 2019

Finland
Regulation Name / Authority

Finnish Medicines Agency (Fimea)

Serialisation Serialisation
Deadline

February 9, 2019

Data Carrier

2D Data Matrix,
Human readable interpretation

Data Elements

  • GTIN or unique NTIN
  • Serial Number (AI 21)
  • Batch/Lot Number (AI 10)
  • Expiration Date (AI 17)

Expert View

The use of NTINs will diminish after 2019

France
Regulation Name / Authority

CIP (Club Inter Pharmaceutique) - / ANSM (French National Agency for Medicines and Health Products Safety)

Batch Coding Batch Coding
Deadline

January 01, 2011

Data Carrier

GS1 Data Matrix ECC200

Data Elements

Unique product identification number (French CIP code / NTIN) - (AI 01), Expiry date (AI 17), Batch/Lot number (AI 10).

Serialisation Serialisation
Deadline

February 09, 2019

Data Carrier

Data Matrix ECC200

Data Elements

  • Unique product identifier GTIN or NTIN
  • Product code
  • Serial number
  • Batch number
  • Expiry date
  • National reimbursement number, not applicable in France

Aggregation Aggregation
Deadline

Not mandatory

Expert View

Until the EU Falsified Medicine Directive is not implemented, all products in France need to be batch coded according to CIP guideline.

Germany
Regulation Name / Authority

NMVS (National System according to EU FMD) - ACS-MAH-System “securPharm”

Serialisation Serialisation
Deadline

February 09, 2019

Data Carrier

Data Matrix ECC200 (ASC/IFA- or GS1-Format)

Data Elements

Unique product identification number (PPN or NTIN), Batch/Lot number, Expiry date, Serial number.

Aggregation Aggregation
Deadline

Not mandatory

Expert View

securPharm is the National Medicines Verification System (NMVS) of Germany. Since 2013, pharmaceutical companies are able to use securPharm and practice their own processes. As such, it serves as a partner within the safety network in Europe provided by the European Medicines Verification Organisation (EMVO). In the Delegated Regulation the national reimbursement number is mentioned. For pharmaceuticals destined for the German market, it is included in the product code in form of the PZN and therefore does not need to be listed as a separate fifth element pursuant to Article 4 (e) of the Delegated Regulation.

European Union / Greece
Regulation Name / Authority

Directive 2011/62/EU / EU Commission

Serialisation Serialisation
Deadline

February 09, 2025

Data Carrier

Data Matrix ECC200

Data Elements

Unique product identification number (e.g. GTIN/NTIN), Batch/Lot number, Expiry date, Serial number, National reimbursement number (if applicable)

Expert View

Greece should comply with EU FMD serialisation requirements Feb 09, 2025.

Greece
Regulation Name / Authority

Greek Ministry of Health & Welfare

Serialisation Serialisation
Deadline

Apr 08, 2004

Data Carrier

Code 128 and EAN-13 on Vignette

Data Elements

Serial number (in Code 128) and Greek EOF code (9 digits) incl. NPO registration number (in EAN-13)

Expert View

Until the EU Falsified Medicine Directive is not implemented, all products in Greece need to be labeled with the respective vignettes. This sticker is issued by EOF (“Ethnikos Organismos Farmakon” / National Organisation for Medicines) free of charge to companies. It is produced by a special aquarelled paper incl. the national emblem and the name of EOF (solely visible by UV). The sticker is 27 x 24mm and contains (typed by EOF): name of the company, production year and sticker number. The manufacturer is obliged to type the following: product name, pharmaceutical form and strength, code number (assigned by EOF and unique to the product) and the retail price. As Greece has +6 years more time for the implementation (Feb 09, 2025), labeling equipment will be andatory for the time being.

European Union / Italy
Regulation Name / Authority

Directive 2011/62/EU / EU Commission

Serialisation Serialisation
Deadline

February 09, 2025

Data Carrier

Data Matrix ECC200

Data Elements

Unique product identification number (e.g. GTIN/NTIN), Batch/Lot number, Expiry date, Serial number, National reimbursement number (if applicable)

Expert View

Italy should comply with EU FMD serialisation requirements Feb 09, 2025.

Italy
Regulation Name / Authority

“Italian Bollini” / Italian MoH

Serialisation Serialisation
Deadline

Jan 04, 2005 “old Bollino” / Dec 31, 2015 “new Bollino”

Data Carrier

2 linear barcodes (Code 39 and ITF) on Bollino (Vignette) and one 2D DataMatrix

Data Elements

New Bollino
3 barcodes: 2 linear barcodes (Code 39 and ITF) encoding the AIC code and the serial number and a 2D DataMatrix encoding the AIC and the serial number.

Expert View

Until the EU Falsified Medicine Directive is not implemented, all products in Italy need to be labeled with the “New Bollini” vignettes. As Italy has +6 years more time for the implementation (Feb 09, 2025), labeling equipment will be mandatory for the time being.

Island
Regulation Name / Authority

Icelandic Medicines Agency

Serialisation Serialisation
Deadline

February 9, 2019

Data Carrier

2D Data Matrix and optionally linear barcode
Human readable interpretation

Data Elements

  • GTIN or unique NTIN
  • Serial Number (AI 21)
  • Batch/Lot Number (AI 10)
  • Expiration Date (AI 17)

Tamper Evident

yes

Expert View

Two different product code carriers i.e. linear barcode / 2D Data Matrix are allowed on the packs at the same time (the pharmacies order primarily on Vnrs). The product code carriers must have the same content i.e. product code.The use of NTINs will diminish after 2019

Sweden
Regulation Name / Authority

LIF Sweden

Serialisation Serialisation
Deadline

February 9, 2019

Data Carrier

2D Data Matrix,
Human readable interpretation

Data Elements

  • GTIN or unique NTIN
  • Serial Number (AI 21)
  • Batch/Lot Number (AI 10)
  • Expiration Date (AI 17)

Tamper Evident

yes

Expert View

The use of NTINs will diminish after 2019

Argentina
Regulation Name / Authority

ANMAT drug traceability system / Administración Nacional de Medicamentos, Alimentos y Tecnología Médica

Serialisation Serialisation
Deadline

August 30, 2015

Data Carrier

GS1 Data Matrix ECC200, GS1 128, RFID tag

Data Elements

  • GTIN (AI 01)
  • Serial Number (AI 21)
  • Batch/Lot Number (AI 10)-optional
  • Exp. Date (AI 17)-optional

Expert View

For the serialization it is suggested to also use expiration date (AI 17) and batch/lot Number (AI 10) additionally to the SGTIN. Argentina doesn’t require aggregation. But as the goal is to have full traceability, aggregation can make sense. For aggregation GS1 recommends the usage of SGTIN’s for bundles and SSCC’s for shipping cases and pallets. On Sep 23, 2016 ANMAT released a new regulation on drug traceability “Disposition 10.564/2016”. This Regulation is including new products: 49 new APIs, a particular category of products registered under "special conditions" (i.e. under a specific Regulation of ANMAT) and all new drugs that are registered in Argentina.

Australia
Regulation Name / Authority

Guidance on TGO 92 / Therapeutic Goods Administration (TGA)

Batch Coding Batch Coding
Deadline

Sep 01, 2020

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01), Expiration Date (AI 17), Batch/Lot Number (AI 10)

Serialisation Serialisation
Deadline

TBD

Data Carrier

TBD

Data Elements

TBD

Expert View

Guidance TGO 91 - which covers non prescription and homoeopathic drugs (etc.) - does not claim for a machine readable code nor requirement. For blood and blood products funded under the National Blood Arrangements of Jan. 2015 some barcode specifications are already in force: Since Jan 01, 2017 suppliers must include the serial number and since Jan 01, 2018 products must fully comply with the GS1 DataMatrix elements identified in the barcode specifications for blood and blood products funded under the National Blood Arrangements.

[Translate to English:] Bahrain
[Translate to English:]
Regulation Name / Authority

SCH Bahrain (Supreme Council for Health). Issuing the System for Tracking and Tracing Medicine Provision and Supply Chain inside the Kingdom of Bahrain

[Translate to English:]
Serialisation Serialisation
Deadline

December, 31 2019

Data Carrier

GS1 Data Matrix ECC200

Data Elements

  • (01) GTIN
  • (21) Serial Number
  • (10) Batch/Lot Number
  • (17) Expiry Date

Tamper Evident

no

[Translate to English:]
Expert View

All Distributors shall start to upload the master data of their products through GS1 UAE starting from November 2017, provided that the deadline for providing the master data shall be the end of April 2018.

Brazil
Regulation Name / Authority

SNCM “Sistema Nacional de Controle de Medicamentos” Law No. 11.903/2009 / ANVISA

Serialisation Serialisation
Deadline

August 01, 2018 (3 batches / see expert view)
April 01, 2022 (All products / see expert view)

Data Carrier

Data Matrix ECC200

Data Elements

GTIN (AI 01) or National Number (NHRN) - (AI 713), Expiration Date (AI 17), Batch/Lot Number (AI 10), Serial Number (AI 21)

Aggregation Aggregation
Deadline

Aug 01, 2018 (3 batches / see expert view)
Apr 01, 2022 (All products / see expert view)

Data Carrier

Possibly GS1 128

Data Elements

Possibly SSCC (AI 00)

Expert View

The deadline for serialization and tracking for all pharmaceuticals (planned for Dec 2016) was suspended on Sep 27, 2016. The RDC 54 has been started on Feb Further specifications: Serial number needs to be unique per GTIN (not anymore per company as the old regulation stated). Serial number length up to 20 digits (not anymore exactly 20 digits as the old regulation stated). On May 11, 2017 RDC of the Drug Traceability Law has been published with a new number RDC157 / 17.

The new deadlines for implementation, within the next five years are as follows:

  • As from Aug 01, 2017: 1 year for serialization and aggregation (of 3 batches per company)
  • As from Aug 01, 2018: 8 months for analysis of results (regarding the 3 batches per company)
  • As from Apr 01, 2019: 3 years for all pharmaceuticals (Rx and possibly also OTC)
  • Final Deadline: Apr 01, 2022

Key topics of RDC 157/2017:

  1. Scope: Exclusion of certain product categories such as OTCs, radiopharmaceuticals, free samples (Art. 2 §1)
  2. Serial number: format of up to 20 alphanumeric characters i.e. aligned with GS1 specs
  3. Inclusion of GTIN in product code (Art. 6); however, the sequence of the data element in the unique identifier is prescribed  suggest to prepare a GS1 Brazil response
  4. Uniqueness of serial number per GTIN (Art. 6); however, serial number must be unique “for eternity” (Art. 6)  suggest to address this in a GS1 response
  5. Manufacturing date *not* part of the unique identifier
  6. For imported drugs serialization can be done either by the manufacturer prior to import or locally in Brazil (Art. 10)
  7. Aggregation only required upon shipment by the registration holder (Art. 7)
  8. Linear barcodes to be kept in parallel to 2 DMC (Art. 9)

China - Human
Regulation Name / Authority

CFDA Decree No.28 / “National e-coding system” / CFDA

Serialisation Serialisation
Deadline

Dec 31, 2015 - ON HOLD since Feb 20, 2016

Data Carrier

Linear Code 128 C

Data Elements

NATIONAL product code (country number, drug category number, drug identification number and the check number (14 digits))

Aggregation Aggregation
Deadline

Dec 31, 2015 - ON HOLD since Feb 20, 2016

Data Carrier

Linear Code 128 C

Data Elements

NATIONAL product code (country number, drug category number, drug identification number and the check number (14 digits))

Expert View

Even if CFDA announced the suspension of the implementation of relevant provisions on drug electronic supervision, most companies still follow the regulation, in waiting for more details on the new traceability system to be implemented. The e-coding system was acquired by “Ali Health” (a subsidiary of Ali Baba) and the usage is voluntary to the companies. GS1 wrote a recommendation letter to advocate for the usage of GS1 standards. These recommendations have been translated into Chinese and leveraged by the local trade associations. New GSP (Good Supply Practice) regulation has been released, it allows the use of GS1 standards without mandating it, but new deadlines are still missing.

China - Veterinary
Regulation Name / Authority

Ministry of Agriculture of the People’s Republic of China

Serialisation Serialisation
Deadline

Jun 30, 2016

Data Carrier

QR Code (UTF-8)

Data Elements

Veterinary drug product tracing code (24-digit number randomly generated by the national veterinary drug product tracing system) containing tracing code, product name, product approval number or registration certificate number of import veterinary drugs, abbreviation of the manufacturing enterprise and contact telephone

Aggregation Aggregation
Deadline

Not mandatory

Expert View

If the uniform veterinary drug two-dimensional code marks cannot be printed on the minimum sales package on the products due to the limitations of the package size for the products with special circumstances such as ampoules, vials less than 5 ml or irregular shaped bottles, the uniformly marked veterinary drug two-dimensional code should be printed on the package of the upper level on the minimum sales package. The specific products should be applied by the manufacturing enterprises of the veterinary drugs, reviewed and confirmed by the Veterinary Bureau of the Ministry of Agriculture.

Egypt
Regulation Name / Authority

Project on Tracing & Tracking Pharmaceutical Preparations
Inside Arab Republic of Egypt

Batch Coding Batch Coding
Deadline

June 1, 2018

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01), Expiration Date (AI 17), Batch/Lot Number (AI 10)

Aggregation Aggregation
Deadline

June 1, 2018

Data Carrier

GS1 128

Data Elements

SSCC (AI 00)

Expert View

First phase (printing the 2D Barcode in the form and the specifications of the ministerial decision) and second phase (aggregation) are splitted in 3 competent entities as A. Drug plants and companies; B. Drug warehouses, distributors and importers. and C. All kinds of pharmacies.

India
Regulation Name / Authority

DGFT (Directorate General of Foreign Trade) - System Development handed over to PHARMACEUTICAL EXPORT PROMOTION COUNSIL OF INDIA (PHARMEXCIL)

Primary Level Packaging
Serialisation Serialisation
Deadline

Apr 01, 2015 (solely mono-cartons); Remaining delayed until further notice

Data Carrier

EAN/UPC or GS1 Data Matrix ECC200 or GS1 128 or GS1 DataBar

Data Elements

GTIN (AI 01), Batch/Lot Number (AI 10), Expiration Date (AI 17) and Serial Number (AI 21)

Secondary Level Packaging
Serialisation Serialisation
Deadline

Oct 01, 2013

Data Carrier

GS1 Data Matrix ECC200 or GS1 128 or GS1 DataBar

Data Elements

GTIN (AI 01), Batch/Lot Number (AI 10), Expiration Date (AI 17) and Serial Number (AI 21)

Aggregation Aggregation
Deadline

Apr 01, 2016 for non-SSI
Apr 01, 2017 for SSI

Data Carrier

GS1 128 x 2

Data Elements

First code: GTIN (AI 01), Batch/Lot Number (AI 10), Expiration Date (AI 17) and Second code:Serial number as SSCC (AI00)

Tertiary Level Packaging
Serialisation Serialisation
Deadline

Oct 01, 2011

Data Carrier

GS1 128 or GS1 Data Matrix ECC200 (first code) / GS1 128 (second code)

Data Elements

a) Shipping cases: First code – GTIN (AI 01), Batch/Lot Number (AI 10), Expiration Date (AI 17) and Serial Number (AI 21) // Second code – SSCC (AI 00);

b) Pallets: SSCC (AI 00)

Expert View

Current regulation applies only for Export Products, regulation for Domestic is still in preparation. Pharmaceutical manufacturers exporting medicines, need to follow the DGFT regulation. On Jan 05, 2016, the Indian DGFT has released the Public Notice 52/2015-2020. Primary level is still exempted from labelling with a 2D barcode. The data elements can optionally be printed in human readable format on primary level. However, this information needs to be provided to the DAVA portal, as the system requires its input and doesn’t except empty fields. In case having no “real” primary level data elements available, some “virtual” information needs to be provided. This “virtual” information set needs to be maintained by the manufacturer. - Regulations for Domestic market are under development. As for Domestic market government wants to have the primary units serialized.

[Translate to English:] Indonesia
[Translate to English:]
Regulation Name / Authority

National Agency of Drug and Food Control
Badan Pengawas Obat dan Makanan (BPOM)

[Translate to English:]
Serialisation Serialisation
Deadline

2020 for all drugs with secondary packaging and all drugs with bottle packing that are larger or equal to 5 ml volume.
2025 for all drugs and processed foods

Data Carrier

QR code issued by BPOM or own 2D data carrier which is published independently (can be however must not be DataMatrix)

Data Elements

  • (AI 90) Product Edition Permission Number
  • (AI 10) Batch Number;
  • (AI 17) Expiration Date;
  • (AI 21) Serial Number
  • (AI 91) ID of Production Facility

[Translate to English:]
Expert View

DRAFT LAW. It is optional to use international standard data carrier as an option to the 2D barcodes issued by BPOM. The 2D barcodes issued by BPOM will be QR codes.

Iran
Regulation Name / Authority

TTAC Executive guideline No. 660/11873 dated Sept. 7, 2014

Serialisation Serialisation
Deadline

Jan 01, 2015

Data Carrier

GS1 Data Matrix

Data Elements

GTIN (AI 01), Serial Number (AI 21), Batch/Lot Number (AI 10), Expiration Date (AI 17)

Aggregation Aggregation
Deadline

Not mandatory

Expert View

The GS1 Data Matrix and the originality number* in coated form will be in a specified place measuring 20 by 40 mm, with a white background and yellow margin. The UID is required to be a 20 digit number, whereas the first 4 or 5 digits of the UID identify the company generating the UID and the remaining numbers are randomly generated.

*In addition to GTIN, UID, Lot and Exp, a 16-digit number will be printed under the scratch label for the patient or end user to use for authentication purposes.

Jordan
Regulation Name / Authority

Guidelines of Identification and Bar coding of Medicinal Products for Human Use / JFDA

Batch Coding Batch Coding
Deadline

Jul 01, 2018

Data Carrier

GS1 Data Matrix

Data Elements

GTIN (AI 01), Expiration Date (AI 17), Batch/Lot Number (AI 10)

Serialisation Serialisation
Deadline

January 01, 2020

Data Carrier

GS1 Data Matrix

Data Elements

GTIN (AI 01), Serial Number (AI 21), Expiration Date (AI 17), Batch/Lot Number (AI 10)

Aggregation Aggregation
Deadline

Not mandatory

Expert View

In human readable format, it is sufficient to print the GTIN close to the GS1 Data Matrix, if the expiration date and batch number are found elsewhere on the pack. A migration period is allowed starting from 01/06/2017 till 30/6/2018. During this period of time it will be allowed to print a 1D / Linear barcode and/or a GS1 Data Matrix on medicinal products on the Secondary Package, however after this period only the GS1 Data Matrix will be allowed.

[Translate to English:] Lebanon
[Translate to English:]
Regulation Name / Authority

Ministry of Public Health

[Translate to English:]
Batch coding Batch coding
Deadline

June 2018

Data Carrier

GS1 2D DataMatrix

Data Elements

  • GTIN (AI 01)
  • EXPIRY DATE (AI 17)
  • BATCH/LOT Number (AI 10)

[Translate to English:]
Expert View

Pilot: Parties and products that will take part of in the Pilot were identified: distributors, LPIA, 6 multinational companies, pharmacy department at the MOH, Syndicate of Hospitals.

[Translate to English:] Norway
[Translate to English:]
Regulation Name / Authority

Norwegian Medicines Agency

[Translate to English:]
Step 1
Serialisation Serialisation
Deadline

January 1, 2018

Data Carrier

Linear barcode and optionally 2D Data Matrix barcode

Data Elements

  • GTIN or unique NTIN
  • Serial Number (AI 21)
  • Batch/Lot Number (AI 10)
  • Expiration Date (AI 17)

Tamper Evident

yes

Step 2
Serialisation Serialisation
Deadline

February 9, 2019

Data Carrier

2D Data Matrix,
Human readable interpretation

Data Elements

  • GTIN
  • Serial Number (AI 21)
  • Batch/Lot Number (AI 10)
  • Expiration Date (AI 17)

Tamper Evident

yes

[Translate to English:]
Expert View

Packs released to the Norwegian market before 9 Feb 2019 must have a linear barcode, and may have 2D Data Matrix. Packs released to the Norwegian market after 9 Feb 2019 must have 2D Data Matrix and must not have linear barcode. The use of NTINs will diminish after 2019.

Oman
Regulation Name / Authority

MH/DGMS/DSS/M/7043 / Directorate General of Medicinal Supplies MoH Oman

Secondary Level Packaging
Batch coding Batch coding
Deadline

Dec 31, 2017

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01), Expiration Date (AI 17), Batch/Lot Number (AI 10)

Serialisation Serialisation
Deadline

Dec 31, 2018

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01), Serial Number (AI 21), Expiration Date (AI 17), Batch/Lot Number (AI 10)

Tertiary level packaging
Batch coding Batch coding
Deadline

Dec 31, 2017

Data Carrier

GS1 Data Matrix ECC200 or GS1 128

Data Elements

GTIN (AI 01), Expiration Date (AI 17), Batch/Lot Number (AI 10)

Expert View

Stickers are not allowed. The implementation is currently not applicable for surgical and lab items. Tertiary packaging will be batch coded either with GS1 Data Matrix ECC200 or GS1 128.

Pakistan
Regulation Name / Authority

Drug Regulatory Authority of Pakistan (DRAP)

Batch Coding Batch Coding
Deadline

TBD

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01), Expiration Date (AI 17), Batch/Lot Number (AI 10)

Expert View

Serialization of primary packs under discussion. However, companies are allowed to avoid this as long as secondary packs are single dosage (mono) packs.

Philippines
Regulation Name / Authority

Guidelines on Implementing FDA Circular No. 2014-011

Batch Coding Batch Coding
Deadline

Jun 30, 2016 - ON HOLD

Data Carrier

Linear code or Data Matrix (possibly GS1)

Data Elements

GTIN (AI 01) , Expiration Date (AI 17), Batch/Lot Number (AI 10)

Expert View

The policy “Unique Global Product Identification Number for Drug Products'‘ requires the use of their so called “Global Product Identification Number” (GPIN) for drug products (which is a unique 14-digit code specific for a product presentation of a specific company that is secured from a global standards organization – similar to a GTIN), the batch number and expiry date. Since Jul 25, 2016 the implementation requirement is on hold.

[Translate to English:] Qatar
[Translate to English:]
Regulation Name / Authority

Hamad Medical Corporation

[Translate to English:]
Tertiary packaging level
Batch coding Batch coding
Deadline

Data Carrier

GS1 Data Matrix ECC200 or GS1-128

Data Elements

  • GTIN (AI 01)
  • EXPIRY DATE (AI 17)
  • BATCH/LOT Number (AI 10)

Secondary level
Batch coding Batch coding
Deadline

Data Carrier

GS1 Data Matrix ECC200,
Human readable interpretation

Data Elements

  • GTIN (AI 01)
  • EXPIRY DATE (AI 17)
  • BATCH/LOT (AI 10)

Russia
Regulation Name / Authority

Federal Law № 61-FZ "Circulation of Medicines" / Federal Service for Surveillance in Healthcare

Serialisation Serialisation
Deadline

Jan 2020 (all drugs)
Essential list might be earlier

Data Carrier

GS1 Data Matrix ECC200

Data Elements

  • GTIN (AI 01)
  • Serial Number (AI 21)
  • Batch/Lot Number (AI 10)
  • Expiration Date (AI 17)
  • Additional Item Identification (AI 240)

Aggregation Aggregation
Deadline

Jan 2020 (all drugs)

Data Carrier

GS1 128

Data Elements

Manufacturers and wholesalers (members of GS1 Russia):
SSCC (AI 00)

Manufacturers only:
sGTIN: GTIN (AI 01) and Serial Number (AI 21)

Wholesalers only (non-members of GS1 Russia):
Identification Code of the tertiary packaging (AI 999): Package extension indicator (N1), wholesale organization identifier (N2-N10), control number (N18)

Expert View

01.02.2017 - 31.12.2017: Experiment on labeling resp. identification.
01.06.2017: Readiness of the Government database.
01.09.2017: Integration of the system with key participants of the pilot project (manufacturer - customs - logistics operator - distributor - pharmacy chain)
01.02.2018: Evaluation of the experiment and submission of the report to the Government of the Russian Federation.
Until 31.12.2018: Labeling of all 100% of pharmaceutical goods. Phases as follows:
Q1 2018: Labeling coverage of 100% of medicinal products released into circulation and intended for provision to individuals with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic, and related tissues, and multiple sclerosis and individuals after organ and (or) tissue transplant;
Q2 2018: Labeling coverage of 100% of medicinal products released into circulation with the cost higher than RUB 500;
Q3 2018: Labeling coverage of 100% of medicinal products released into circulation with the cost higher than RUB 100;
Q4 2018: Labeling coverage of 100% of medicinal products released into circulation.

Saudi Arabia
Regulation Name / Authority

Guidance for the industry on Saudi Drug Code (SDC) and drug barcoding specifications / Saudi FDA

Batch Coding Batch Coding
Deadline

Mar 21, 2015

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01), Batch/Lot Number (AI 10), Expiration Date (AI 17)

Serialisation Serialisation
Deadline

Mar 12, 2017

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01), Serial Number (AI 21), Batch/Lot Number (AI 10), Expiration Date (AI 17)

Aggregation Aggregation
Deadline

Not mandatory

Expert View

In the first draft regulation, SFDA was claiming for the coding of the pack size. Since Jul 07, 2014 this obsolete as a GTIN is already providing the pack size information. - Regulations are stating that aggregation will not become mandatory but when companies want, for business reasons it will be allowed.

[Translate to English:] South Africa
[Translate to English:]
Regulation Name / Authority

National Department of Health South Africa

[Translate to English:]
Tertiary packaging
Batch coding Batch coding
Deadline

December 30, 2018

Data Carrier

GS1 128 Linear Barcode or GS1 Data Matrix

Data Elements

  • GTIN (01)
  • BATCH/LOT (10)
  • EXPIRATION DATE (17)

Aggregation Aggregation
Deadline

June 30, 2022

Data Carrier

GS1 128 Linear Barcode or GS1 Data Matrix

Data Elements

  • GTIN (01)
  • BATCH/LOT (10)
  • EXPIRATION DATE (17)
  • SERIAL NUMBER (21)

Secondary packaging
Batch coding Batch coding
Deadline

Sep 01, 2020

Data Carrier

GS1 DataMatrix

Data Elements

  • GTIN (01)
  • BATCH/LOT (10)
  • EXPIRATION DATE (17)

Serialisation Serialisation
Deadline

Jun 30, 2022

Data Carrier

GS1 DataMatrix

Data Elements

  • GTIN (01)
  • BATCH/LOT (10)
  • EXPIRATION DATE (17)
  • SERIAL NUMBER (21)

South Korea
Regulation Name / Authority

Korean Pharmaceuticals Information Service / Ministry for Food and Drug Safety (MFDS - formely Korean FDA)

Batch Coding Batch Coding
Deadline

Jan 01, 2010 (solely KDC coding); Jan 01, 2012 (specific products); Jan 01, 2013 (all Rx products)

Data Carrier

GS1 Data Matrix ECC200 or GS1 128

Data Elements

KDC (Korean Drug Code / NTIN) - (AI 01), Expiration Date (AI 17) and Batch/Lot Number (AI 10)

Serialisation Serialisation
Deadline

Jan 01, 2015 (selected products); Jan 01, 2016 (all products)

Data Carrier

GS1 Data Matrix ECC200 or GS1 128 or RFID

Data Elements

KDC (Korean Drug Code / NTIN) - (AI 01), Serial Number (AI 21), Batch/Lot Number (AI 10), Expiration Date (AI 17)

Aggregation Aggregation
Deadline

Not mandatory

Expert View

Reporting transition period of 6 months to Jul 01, 2016. Even if aggregation is not mandatory until now, all producers are already using aggregation systems for convenience during warehousing / release.

[Translate to English:] Switzerland
[Translate to English:]
Regulation Name / Authority

Swiss Federal Office of Public Health

[Translate to English:]
Expert View

Consultation on the provisions dealing with safety features will start during the second half of 2018, but the date for the entry into force of these provisions has not been set yet.

Taiwan
Regulation Name / Authority

Taiwan Food and Drug Administration (TFDA)

Batch Coding Batch Coding
Deadline

Jan 01, 2018 (for secondary and tertiary level)

Data Carrier

GS1 Data Matrix ECC200 (secondary) / GS1 Data Matrix ECC200 or GS1 128 (tertiary)

Data Elements

GTIN (AI 01), Batch/Lot Number (AI 10) and Expiration Date (AI 17)

Serialisation Serialisation
Deadline

Jan 01, 2019 (for secondary and tertiary level)

Data Carrier

GS1 Data Matrix ECC200 (secondary) / GS1 Data Matrix ECC200 or GS1 128 (tertiary)

Data Elements

GTIN (AI 01), Serial Number (AI 21), Batch/Lot Number (AI 10) and Expiration Date (AI 17)

Aggregation Aggregation
Deadline

Jan 01, 2020

Expert View

The requirements on primary level packaging have been removed.

[Translate to English:] Tunisia
[Translate to English:]
Batch coding Batch coding
Deadline

January 1, 2019

Data Carrier

GS1 2D DataMatrix

Data Elements

  • (01) GTIN
  • (10) Batch/Lot Number
  • (17) Expiry Date

[Translate to English:]
Expert View

DRAFT rule from the MoH

Turkey
Regulation Name / Authority

“Regulation Regarding the Packaging and Labeling of Medicinal Products for Human Use” Official Gazette 25904 from 12/08/2005 – İTS „ilaç takip sistemi“ / Turkey MoH

Serialisation Serialisation
Deadline

Jun 01, 2010

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01), Serial Number (AI 21), Expiration Date (AI 17), Batch/Lot Number (AI 10)

Aggregation Aggregation
Deadline

Jun 01, 2010

Data Carrier

GS1 128

Data Elements

SSCC (AI 00)

Expert View

Turkey requires full aggregation. So also bundles, shipping cases and pallets need to be serialized. These packaging levels are called transportation units and are numbered using the SSCC (Serial Shipping Container Code).

United Arab Emirates
Regulation Name / Authority

Dubai Health Authority - DHA

Batch Coding Batch Coding
Deadline

Jan 01, 2017

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01), Expiration Date (AI 17), Batch/Lot Number (AI 10)

Aggregation Aggregation
Deadline

TBD

Expert View

Serialization of primary packs under discussion. However, companies are allowed to avoid this as long as secondary packs are single dosage (mono) packs.

[Translate to English:] Ukraine
[Translate to English:]
Regulation Name / Authority

State Service of Ukraine on Medicines and Drug Control

[Translate to English:]
Serialisation Serialisation
Deadline

October 18, 2018

Data Carrier

GS1 bar code, possibly Data Matrix

Data Elements

  • (01) GTIN
  • (21) Serial number
  • (10) Batch number
  • (17) Expiry date

Other data to be included to the packaging:

  • the name of the medicinal product
  • the name and address of its manufacturer
  • registration number
  • methods of application; dose of the active substance in each unit and their amount in the package
  • storage conditions;precautions

Tamper Evident

no

[Translate to English:]
Expert View

Draft rule. Starting October 24, 2017, the State Service of Ukraine on Medicines and Drug Control introduces the implementation of the first phase of the pilot project.

USA
Regulation Name / Authority

Drug Quality and Security Act (HR 3204) - Title II: Drug Drug Supply Chain Security Act (DSCSA) / US FDA

Serialisation Serialisation
Deadline

Nov 27, 2017

Data Carrier

Data Matrix ECC200

Data Elements

GTIN (AI 01), Serial Number (AI 21), Expiration Date (AI 17) and Batch/Lot Number (AI 10)

Aggregation Aggregation
Deadline

Nov 01, 2023 (To be decided)

Data Carrier

To be decided

Data Elements

To be decided

Expert View

Even if aggregation is not mandatory until now, the “big 3 wholesalers” already claimed for using aggregation systems and to follow the HDMA guidelines. They wrote a letter to all their customers (pharmaceutical manufacturers).

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