Global Compliance

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Global Compliance

Pharmaceutical and food safety regulations exist globally to combat counterfeit drugs and maintain quality and safety standards. Our serialization and traceability solutions are designed to keep up with trade regulations worldwide. This enables our clients to seamlessly conform with various global mandates of countries including the United States, European Union, India, Brazil, South Korea, Saudi Arabia and Russia.

Regulations can be complex but the compliance process doesn’t have to be

We pride ourselves on our on-demand support and after-service. This means that you can rely on our experts for a detailed walk-through to better understand the serialization mandates. Browse through our country-specific guides below for an overview.

Brazil (ANVISA)

Serialization Status: Required
Code Format - 2D Data Matrix
GTIN - AI (01)
ANVISA Registry Number
Expiration Date - AI (17)
Batch/Lot Number - AI (10)
Serial Number - AI (21)

Our products are fully compliant with the serialization needs of the Brazil ANVISA.

Brazil ANVISA requirements
Deadline	April 2022
Secondary Packaging Requirement	2D GS1 barcode encoding GTIN along with a batch number, expiry date serial number and ANVISA Reg No.
Reporting	Each member of the drug handling chain shall electronically record and communicate data corresponding to instances of events occurring with the drug under their custody (full Track and Trace system with centralized data)
Aggregation	Yes
OTC Included	Yes

India (iVEDA)

Serialization Status: Required
Code Format - 2D Data Matrix
GTIN - AI (01)
Expiration Date - AI (17)
Batch/Lot Number - AI (10)
Serial Number - AI (21)

Our products are fully compliant with the serialization needs of the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA).

India iVEDA requirements
Deadline	April 2022
Primary Packaging Requirement	GTIN along with a batch number, expiry date and unique ID of the primary pack
Secondary Packaging Requirement	1D or 2D GS1 barcode encoding GTIN along with a batch number, expiry date and unique ID of the secondary pack.
Tertiary Packaging Requirement	1D linear barcode encoding, along with a batch number, expiry date and unique serial number [Serial Shipping Container Code (SSCC)] on the tertiary pack.
Aggregation	Yes
OTC Included	No

Russia (MDLP)

Serialization Status: Required
Code Format - 2D Data Matrix
GTIN - AI (01)
Unique Serial Number - AI (21)
Key (4 Digit Code) - AI (91)
Signature - AI (92)

Our products are fully compliant with the serialization mandate of the Russian Federal Law No. 425-FZ (Decree No 1556).

Russian MDLP Federal Law Mandate
Deadline	July 2020
Primary Packaging Requirement	GTIN (Global Trade Item Number) assigned as part of the GS1 system.
Secondary Packaging Requirement	2-D Barcode (GTIN , Serial Number, Key and Signature) in DataMatrix ISO ECC-200 format per GOST R ISO / IEC 16022-2008 with GS1 RUS Data Structure.
Tertiary Packaging Requirement	Linear bar code in the GS1-128 (Code 128) format per GOST R ISO / IEC 15417-2013.
Aggregation	Yes
OTC Included	Yes

European Union (FMD)

Serialization Status: Required
Code Format - 2D Data Matrix
GTIN - AI (01)
Expiration Date - AI (17)
Batch Number - AI (10)
Serial Number - AI (21)
National Health Number - Where Necessary

Our solutions are fully compliant with the serialization needs of the Falsified Medicines Directive.

European Union FMD requirement
Deadline	February 2019
Serialization	Manufacturers must mark packages with a product identifier, serial number, batch number and expiry date. A national reimbursement number can also be included if needed.
Verification	Secondary level serialization is needed for product verification. Safety features such as anti-tampering devices also have to be verified.
Reporting	All information must be reported to the European Medicines Verification System (EMVS) to verify authenticity and make the medicine eligible for sale. Container Code (SSCC)] on the tertiary pack.
Aggregation	No
OTC Included	No

US (DSCSA)

Serialization Status: Required
Code Format - 2D Data Matrix
GTIN - AI (01)
Expiration Date - AI (17)
Batch/Lot Number - AI (10)
Serial Number - AI (21)

Our products are fully compliant with America’s Drug Quality and Security Act.

United States DSCSA requirements
Deadline	Manufacturer- 2017; End-to-end – November 2023
Requirement (2017)	Nov 2017 – Manufacturers and repackagers must serialize packages of drug products using a product identifier (GS1 Global Trade Item Number^® [GTIN^®] or FDA National Drug Code [NDC]), serial number, lot number and expiration date, and embed this information in a DataMatrix barcode. Provision of TI, TH, TS in an electronic format should be available.
Requirement (2019)	Nov 2019 – Wholesalers must accept only serialized products and must verify unique product identifiers
Requirement (2023)	Nov 2023 – Wholesalers must provide information that would allow supply-chain partners to trace ownership back to the manufacturer or repackager.
Aggregation	Yes
OTC Included	No

Nigeria (NAFDAC MAS)

Serialization Status: Required
Code Format - Scratch Off Labels

Scratch off Labels with alphanumeric codes printed on to them.

Our products are fully compliant with Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) MAS mandates.

Nigeria NAFDAC MAS requirements
Function	The scheme uses scratch codes and text messages to enable consumers to verify the authenticity of medicines at the point of purchase.
Process	The consumer scratches a panel on the product which reveals a unique, one-time-use PIN. The PIN is sent toll-free to a short code using any of the GSM operators
Secondary Packaging Requirement	1D or 2D GS1 barcode encoding GTIN along with a batch number, expiry date and unique ID of the secondary pack.
Result	The consumer receives a text message verifying if the product is genuine or fake.

Jordan (FDA)

Serialization Status: Required
Code Format - 2D Data Matrix
GTIN - AI (01)
Expiration Date - AI (17)
Batch/Lot Number - AI (10)
Serial Number - AI (21)

Our products are fully compliant with the serialization needs of the Jordan FDA.

Jordan FDA requirements
Deadline	31^st Dec 2021
Secondary Packaging Requirement	2D GS1 barcode encoding GTIN along with a batch number, expiry date and serial number.
Aggregation	Optional
OTC Included	No

Bahrain (NHRA)

Serialization Status: Required
Code Format - 2D Data Matrix
GTIN - AI (01)
Expiration Date - AI (17)
Batch/Lot Number - AI (10)
Serial Number - AI (21)

Our products are fully compliant with the serialization needs of the Bahrain NHRA.

Bahrain NHRA requirements
Deadline	1^st May 2022
Secondary Packaging Requirement	2D GS1 barcode encoding GTIN along with a batch number, expiry date and serial number.
Tertiary Packaging Requirement	NHRA requires both the case/shipper and the pallet (tertiary) packaging aggregation barcodes & serialization.
Aggregation	Yes
OTC Included	Yes

Saudi Arabia (SFDA)

Serialization: Required
Code Format: 2D Data Matrix & GS1-128 Barcode
GTIN - AI(01) - 14 digits
Expiration Date - AI(17) - YYMMDD Format
Batch/Lot Number - AI(10) - Up to 20 alphanumeric characters in length
Serial Number - AI (21) - Up to 20 alphanumeric characters in length

Our Products are fully compliant with serialization needs of the SFDA.

Saudi SFDA requirements
Deadline	August 2020
Secondary Packaging Requirement	2D GS1 barcode encoding GTIN along with batch number, expiration date and serial number.
Tertiary Packaging Requirement	Logistic Units must be aggregated and barcoded using a GS1-128 barcode.
Aggregation	Yes
OTC Included	Yes

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Global Compliance

Regulations can be complex but the compliance process doesn’t have to be

Brazil (ANVISA)

India (iVEDA)

Russia (MDLP)

European Union (FMD)

US (DSCSA)

Nigeria (NAFDAC MAS)

Jordan (FDA)

Bahrain (NHRA)

Saudi Arabia (SFDA)

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