European Regulatory

EUROPEAN UNION DRUG BARCODING REQUIREMENTS

REGULATORY AGENCY	European Medicines Agency (EMA)
REGULATION NAME	Falsified Medicines Directive (FMD) and final Delegated Regulation (DR)
COMPLIANCE DATES	9th February, 2019: The serialization of drugs as described in the DR must occur in EU Member States that did not already have a drug tracing regulation in 2011. Italy, Belgium and Greece are given until February 9, 2025 to meet these requirements, although all have said they will either meet the requirements by February 9, 2019, or soon after 9th February, 2025: The serialization of drugs as described in the DR must occur in EU Member States that already had a drug tracing regulation in 2011. This includes Italy, Belgium and Greece
APPLIES TO	Domestic manufacturers and Marketing Authorization Holders of pharmaceutical products Importers and parallel traders of pharmaceutical products

UNIT-LEVEL PACKAGING (UNITS OF SALE)

BARCODE SYMBOLOGY	Data Matrix ECC200
BARCODE CONTENTS	The “Unique Identifier” consisting of: Product code, identifying the name, form, strength, pack size and type; Serial number, up to 20 alphanumeric characters A national reimbursement number identifying the medicinal product, if required by the Member State where the product is intended to be placed on the market; Batch number Expiry date
SERIAL NUMBER RANDOMIZATION	Must be generated by a deterministic or a non-deterministic randomization algorithm resulting in the probability that the serial number can be guessed being negligible, and in any case lower than one in ten thousand
SERIAL NUMBER REUSE	The combination of the product code and the serial number shall be unique to a given pack until at least one year after the expiry date or five years after sale or distribution
HUMAN READABLE EXPIRY DATE FORMAT	2 digits or at least 3 characters of ‘month’ and 4 digits of ‘year’
BARCODE DATA ENCODING	Any encoding scheme that conforms with ISO/IEC 15418:2009 (this includes GS1 Application Identifiers and ASC MH 10 Data Identifiers and Maintenance)
PRODUCT CODE NOTES	“The product code shall follow a coding scheme and begin with characters specific to the coding scheme used. It shall also contain characters or character sequences identifying the product as a medicinal product. The resulting code shall be less than 50 characters and be globally unique.” GS1 GTINs fulfill this requirement but some member states will expect the use of a National Trade Item Number (NTIN), or a National Health Reimbursement Number (NHRN). Check with each member state for their specific requirements
FREE SAMPLES MUST BE MARKED?	Yes, data uploaded to the EU Hub just like other saleable products, but these units must be decommissioned when shipped as samples

HOMOGENEOUS PACKAGING

BARCODE SYMBOLOGY	Not Applicable
BARCODE CONTENTS	Not Applicable

LOGISTICS UNITS

LOGISTICS UNITS MUST BE SERIALIZED?

AGGREGATION DATA CAPTURE

UNIT-TO-CASE AGGREGATION CAPTURE?

Not Required

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	Yes (National Repositories)
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	Yes, EU HUB
SEND UNIT DATA TO TRADING PARTNER?	As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	Not applicable
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	Not applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	Not required by law but will be necessary in many cases

AUTHENTICATION

WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION?	EMVO and National Repositories
MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY?	No, but manufacturers must indicate regions where the product(s) could be distributed
DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT?	Only dispensers, others optional except for products with a “high likelihood of illegitimacy”
DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT?	Decommissioning is required by anyone who exports EU drugs outside of the EU

GOVERNMENT REPORTING

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

REGULATION ON MEDICAL DEVICES AND IVD INCLUDING UDI

REGULATORY AGENCY	European Commision
REGULATION NAME	Unique Device Identification Rule
COMPLIANCE DATES	Phased MDR implementation: 26 May 2021: Assignment of UDI - all classes (Transition period until 26 May 2025) 26 May 2021: UDI labelling - Class 3 & implantable devices 26 May 2023: UDI labelling - Class 2 26 May 2025: UDI labelling - Class 1 Important to also take into the deadline related to the other parts - not UDI - of the Regulation. Deadlines +2 years for Direct Marking Phased IVDR implementation: 26 May 2022: Assignment of UDI - all classes 26 May 2023: UDI labelling - Class D 26 May 2025: UDI labelling - Class B and C 26 May 2027: UDI labelling - Class A
APPLIES TO	Apply to all medical devices placed on the market except custom-made devices

PRIMARY PACKAGING

(Packaging which is in direct physical contact with the active ingredient)

BARCODE SYMBOLOGY	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
FREE SAMPLES MUST BE MARKED?	Primary Level Packaging Is defined as the first level of packaging in direct contact with the product and marked with an AIDC (Automatic Identification and Data Capture) data carrier either on the packaging or on a label affixed to the packaging. It may consist of a single item or group of items for a single therapy such as a Kit. For packaging configurations that include a retail consumer trade item, primary packaging is a packaging level below the retail consumer trade item.
FREE SAMPLES MUST BE MARKED?	No

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	Due to the wide variety of secondary level packaging configurations for medical devices, following is additional guidance. In the following examples, the outer carton is the secondary level packaging. One device packaged in primary level packaging contained in a single outer carton. A collection of more than one of the same medical device, each packaged in primary level packaging, contained in a single outer carton (includes shelf packs). Multiple, different medical devices intended for one therapy packaged in a single tray, and that single tray contained in a single outer carton (may also be referred to as a Kit). Multiple, different medical devices intended for one therapy packaged in a single tray, and several of those trays are contained in a single outer carton (may also be referred to as a Kit)
FREE SAMPLES MUST BE MARKED?	No

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?

Yes

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	Yes (EUDAMED :- European Database for Medical Devices)
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?	European Commision
MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY?	Yes (Import & Exports)
DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT?	Yes
DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT?	Yes

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	Yes
DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED?	Yes

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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