Saudi Regulatory

SAUDI DRUG BARCODING REQUIREMENTS

REGULATORY AGENCY	Saudi Food and Drug Authority
REGULATION NAME	Saudi Drug Code [SDC] & Barcoding Specifications, Version 6.1
COMPLIANCE DATES	March 12, 2017: All the GS1 Datamatrix barcode affixed by the manufacturer must include a GS1 serial number Deadlines for mandatory aggregation postponed till further notice
APPLIES TO	Domestic drug manufacturers of human and veterinary drugs including prescription and over-the-counter drugs Foreign drug manufacturers of human and veterinary drugs including prescription and over-the-counter drugs

SECONDARY PACKAGING

BARCODE SYMBOLOGY	GS1 Datamatrix
BARCODE CONTENTS	A GTIN The expiration date of the drug; Batch/lot number Unique Serial Number
SERIAL NUMBER RANDOMIZATION	Not Specified
SERIAL NUMBER REUSE	Not Specified
HUMAN READABLE EXPIRY DATE FORMAT	Month Year
BARCODE DATA ENCODING	GS1 Standards
PRODUCT CODE NOTES	SFDA technical documents define a 10 character “Saudi Drug Code”, but it appears they do not expect it to be encoded in the barcode. “The GS1 Data Matrix barcode must be printed on one side of the secondary packaging preferably on a flat surface. To facilitate the reading process, it should be placed on the same side where possible.”
FREE SAMPLES MUST BE MARKED?	No
STICKERING AFTER MANUFACTURING ALLOWED?	Yes

HOMOGENEOUS CASES

BARCODE SYMBOLOGY	GS1 DataMatrix or GS1-128
BARCODE CONTENTS	GTIN + serial number

LOGISTICS UNIT

LOGISTICS UNITS MUST BE SERIALIZED?

Yes, SSCC

DATA CAPTURE

UNIT-TO-CASE AGGREGATION CAPTURE?

Yes

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	Yes
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND UNIT DATA TO TRADING PARTNER?	As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	Yes
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	As applicable

AUTHENTICATION

WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION?	SFDA
MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY?	Yes
DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT?	Not Specified
DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT?	Not Specified

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	Yes
DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED?	Not Specified

GUIDANCE ON REQUIREMENTS FOR UNIQUE DEVICE IDENTIFICATION FOR MEDICAL DEVICES

REGULATORY AGENCY	SFDA- Saudi Food and Drug Authority
REGULATION NAME	Guidance/Agreement
COMPLIANCE DATES	The effective date of SFDA database (Saudi-DI) on 1 October 2020. Applicant can submit all required data within the system. Class D (High risk) 1 September 2023 Class B & C (Medium risk) 1 September 2023 Class A (Low risk) 1 September 2024
APPLIES TO	Local and Overseas Medical Devices Manufacturers, Authorized Representative and importers.

SECONDARY PACKAGING

(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)

BARCODE SYMBOLOGY	GS1 DataMatrix (inter alia, ID/linear bar code, 2D/Matrix bar code, RFID)
BARCODE CONTENTS	GTIN (AI 01) Expiry Date (AI 17) Batch Number (AI 10) Serial Number (AI 21)
SERIAL NUMBER RANDOMIZATION	NA
SERIAL NUMBER REUSE	No
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	UDI – PI
PRODUCT CODE NOTES
FREE SAMPLES MUST BE MARKED?	Not Specified

TERTIARY PACKAGING

(A shipper containing one or more secondary packs)

BARCODE SYMBOLOGY	SSCC
BARCODE CONTENTS	GS1-128 (SSCC)

AGGREGATION DATA CAPTURE

Parent-Child Mapping Aggregation Capture?

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	UDI database (SAUDI-DI)
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	No Specified
SEND UNIT DATA TO TRADING PARTNER?	No Specified
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	No Specified
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	No Specified
SEND AGGREGATION DATA TO TRADING PARTNER?	No Specified

AUTHENTICATION

WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION?	Through SFDA’s online Portal
MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY?	Proposed (Import & Exports)
DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT?	Not Specified
DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT?	Not Specified

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	Yes (Proposed)
DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED?	Not Specified

Source and Credit: This information is fully or partly based on the GS1 master document (all rights reserved). As GS1 does not control the content of the information, GS1 shall not be held liable, under any circumstance, if it differs from the master document.

DISCLAIMER

This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just a possible interpretation of information available in the public domain and that interpretation is subject to change. This information does not constitute legal advice.

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For Further Information, please contact our Compliance Team at info@kevision.in