Global Pharmaceutical Regulations & Requirements
Status
Required
Aggregation
Not required
Traceability
Yes
GS1 Standard
Required
Reporting
Yes
Category
Requirements
SR
Serialization Requirements
- GTIN
- Lot number
- Expiry date
- Serial number
Status
01-Jan-23
Aggregation
Not required
Traceability
N/A
GS1 Standard
Required
Reporting
No
Category
Requirements
SR
Serialization Requirements
- GTIN
- Batch/lot number
- Expiry date
- Serial number
Status
Required
Aggregation
Required
Traceability
Yes
GS1 Standard
Required
Reporting
Yes
Category
Requirements
SR
Serialization Requirements
- GTIN
- Batch/lot number
- Expiry date
- Serial number
Status
01-Apr-22
Aggregation
Supported but not required
Traceability
N/A
GS1 Standard
Required
Reporting
No
Category
Requirements
SR
Serialization Requirements
- GTIN
- Batch/lot number
- Expiry date
- Serial number Length 1 digit fixed
- ANVISA registration number
Status
No deadline announced
Aggregation
Required
Traceability
Yes
GS1 Standard
Accepted, not required
Reporting
Yes
Category
Requirements
DC
Data Carrier
- Linear barcode
- DataMatrix
- RFID
- HRI
SR
Serialization Requirements
- 20-digit code (7-digit product ID + 9-digit SN + 4-digit check digits) in a linear barcode
- GS1 standards using a GTIN as product code with the relevant application identifiers in a 2D DataMatrix code
Status
Deadline August 2026
Aggregation
NA
Traceability
Yes
GS1 Standard
Required
Reporting
Yes
Category
Requirements
DC
Data Carrier
- DataMatrix
- DataMatrix or GS1 128
SR
Serialization Requirements
- Global Trade Item Number (GTIN)
- Batch Number
- Expiration Date
- Unique Serial Number
Status
Active
Aggregation
Not required
Traceability
Yes
GS1 Standard
Required
Reporting
Yes
Category
Requirements
SR
Serialization Requirements
- GTIN
- Batch/lot number
- Expiry date
- Serial number
- Optional elements (e.g. reimbursement number)
Status
Required now
Aggregation
Required
Traceability
1 up, 1 down
GS1 Standard
Accepted, not required
Reporting
Yes
Category
Requirements
SR
Serialization Requirements
- Pack level (1)
- Packager code (3)
- Pack type (1)
- Serial number (10)
- Check digit (1)
- Pack level (1)
- Packager code (3)
- Pack type (1)
- Serial number
- Check digit (1)
Status
01-Jan-23
Aggregation
Required
Traceability
1 up, 1 down
GS1 Standard
Accepted, not required
Reporting
Yes (via CSV file upload)
Category
Requirements
SR
Serialization Requirements
- GTIN or AI (distribution permit number)
- Serial number
- Expiry date
- Batch/Lot
- Requirements at tertiary, secondary & primary (including SN) levels
- Requirement on primary packaging only if there is not an anti-tampering device on the packaging level above
Status
No deadline announced
Aggregation
Not required
Traceability
N/A
GS1 Standard
Required
Reporting
No
Category
Requirements
SR
Serialization Requirements
- GTIN
- Batch/Lot
- Expiry date
- Serial number
Status
No deadline announced
Aggregation
Not required
Traceability
N/A
GS1 Standard
Accepted, not required
Reporting
Yes
Category
Requirements
SR
Serialization Requirements
- GTIN
- Batch/Lot
- Expiry date
- Serial number
Status
Does not seem required
Aggregation
Not required
Traceability
N/A
GS1 Standard
Required
Reporting
Yes
Category
Requirements
SR
Serialization Requirements
- GTIN
- Batch/Lot
- Expiry date
Status
01-Jan-23
Aggregation
Required
Traceability
Yes
GS1 Standard
Required
Reporting
Yes
Category
Requirements
SR
Serialization Requirements
- GTIN
- Batch/Lot
- Expiry date
- Serial number
Status
No deadline announced
Aggregation
Required
Traceability
Yes
GS1 Standard
Required
Reporting
Yes
Category
Requirements
SR
Serialization Requirements
- GTIN
- Batch/Lot
- Expiry date
- Serial number
Status
Active
Aggregation
Not required
Traceability
N/A
GS1 Standard
Required
Reporting
No
Category
Requirements
DC
Data Carrier
- DataMatrix (Secondary)
- DataMatrix or GS1 128 (Tertiary)
SR
Serialization Requirements
- GTIN
- Batch/Lot
- Expiry date
- Serial number
Status
Does not seem required
Aggregation
Required
Traceability
N/A
GS1 Standard
Required
Reporting
No
Category
Requirements
DC
Data Carrier
- DataMatrix (Secondary)
- DataMatrix or GS1 128 (Tertiary)
SR
Serialization Requirements
- DataMatrix (Secondary)
- DataMatrix or GS1 128 (Tertiary)
Status
Active
Aggregation
Required
Traceability
Yes
GS1 Standard
Required
Reporting
Yes
Category
Requirements
SR
Serialization Requirements
- GTIN
- Serial number
- Crypto key (AI 91)
- Crypto signature (AS 92)
Status
Active
Aggregation
Required
Traceability
Yes
GS1 Standard
Required
Reporting
Yes
Category
Requirements
SR
Serialization Requirements
- GTIN
- Batch/Lot
- Expiry date
- Serial number
- GLN for local factories and warehouses
Status
Active
Aggregation
Not required
Traceability
N/A
GS1 Standard
Required
Reporting
No
Category
Requirements
SR
Serialization Requirements
- GTIN
- Batch/Lot
- Expiry date
- Serial number
Status
Active
Aggregation
Not required
Traceability
N/A
GS1 Standard
Required
Reporting
Voluntary
Category
Requirements
SR
Serialization Requirements
- Product code [GTIN or Nordic / National Trade Item Number (NTIN)]
- SN
- Expiry date
- Batch/Lot
Status
Active
Aggregation
Not required
Traceability
N/A
GS1 Standard
Required
Reporting
Yes
Category
Requirements
SR
Serialization Requirements
- GTIN
- Batch/Lot
- Expiry date
- Serial number
Status
Active
Aggregation
Not required
Traceability
N/A
GS1 Standard
Required
Reporting
Yes (to BrandSync)
Category
Requirements
SR
Serialization Requirements
- GTIN
- Batch/Lot
- Expiry date
- Serial number
- GLNs required for manufacturers, dispatchers/warehouses, importers, wholesalers/distributors, pharmacies, hospital pharmacies
Status
No deadline announced
Aggregation
Not required
Traceability
N/A
GS1 Standard
N/A
Reporting
Yes
Category
Requirements
SR
Serialization Requirements
- Drug code (identifies name of drug, INN, dosage, formulation, SKU)
- Batch/Lot
- Expiry date
- Serial number
Status
27-Nov-23
Aggregation
Must comply by Nov. 27, 2023
Traceability
Yes
GS1 Standard
Required
Reporting
Yes
Category
Requirements
SR
Serialization Requirements
- GTIN
- Batch/lot number
- Expiry date
- Serial number
Status
TBD after pilot
Aggregation
Not required
Traceability
N/A
GS1 Standard
N/A
Reporting
Yes
Category
Requirements
SR
Serialization Requirements
- GTIN
- Serial number
- Crypto key (AI 91)
- Crypto signature (A! 92)
Status
2023
Aggregation
Required
Traceability
Yes
GS1 Standard
Required
Reporting
Yes
Category
Requirements
DC
Data Carrier
- DataMatrix (Primary)
- DataMatrix or GS1 128 (Outer)
SR
Serialization Requirements
- GTIN
- Batch/lot number
- Expiry date
- Serial number
Status
Effective from 30th June 2015
Aggregation
Not required
Traceability
N/A
GS1 Standard
N/A
Reporting
Yes
Category
Requirements
SR
Serialization Requirements
- Global Product Identification Number (GPIN)/GTIN: All sellable pharmaceutical units must carry a GPIN/GTIN, a globally recognized identifier.
- Batch/Lot Number
- Expiration Date
- Establishment Number issued by the FDA
Status
Effective from 1st August 2024
Aggregation
NA
Traceability
Yes
GS1 Standard
Required
Reporting
Yes
Category
Requirements
DC
Data Carrier
- Product specific QR code or bar code of the manufacturer
SR
Serialization Requirements
- The product nameThe generic name and strength
- Batch number
- Date of manufacture
- Date of expiry
- Price of the product
- Name of the manufacture and site address
- Sticker to be placed on each commercial pack indicating the wordings ‘NMRA approved
Status
No information found
Aggregation
Yes
Traceability
Yes
GS1 Standard
Required
Reporting
Yes
Category
Requirements
DC
Data Carrier
- DataMatrix (Primary)
- DataMatrix or GS1 128 (Tertiary Packaging)
SR
Serialization Requirements
- GTIN
- Expiry date
- Batch/Lot
- Serial number
Status
Serialization Reporting: 03-06-2026 <br> Aggregation Reporting:01-12-2026
Aggregation
Yes
Traceability
Yes
GS1 Standard
Required
Reporting
Yes
Category
Requirements
DC
Data Carrier
- DataMatrix (Primary)
- DataMatrix or GS1 128 (Tertiary Packaging)
SR
Serialization Requirements
- Global Trade Item Number (GTIN) 14
- Batch or lot number Up to 20
- Expiration date (YYMMDD) 6
- Serial number (SN) Up to 20
Status
No information found
Aggregation
Required
Traceability
Yes
GS1 Standard
Required
Reporting
Yes
Category
Requirements
DC
Data Carrier
- DataMatrix (Primary)
- DataMatrix or GS1 128 (Tertiary Packaging)
SR
Serialization Requirements
- GTIN
- Batch/Lot
- Expiry date
- Serial number
Status
EFFECTIVE DATE: 26/01/2026
Aggregation
Yes
Traceability
Yes
GS1 Standard
Required
Reporting
Yes
Category
Requirements
DC
Data Carrier
- DataMatrix (Primary)
- DataMatrix or GS1 128 (Tertiary Packaging)
SR
Serialization Requirements
- Global Trade Item Number (GTIN)
- batch or lot number
- expiry date
- serial number
