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The International Coalition of Medicines Regulatory Authorities (ICMRA) released a report which provides technical recommendations, strongly focused on interoperability. The document is drawn up by the ICMRA in cooperation with WHO (World Health Organization). The referred recommendations are continuation of ICMRA`s 2017 paper, which analyzed the potential public health benefits of interoperability. You could meet the recommendations below, divided according to the subject matter.

 

ICMRA`s recommendations focus on traceability systems in the pharma industry aiming the provision of  interoperability.

 

 

 

#1 Recommendations regarding the product identification

 

Use numeric product identifiers

The report recommends the use of numeric identifiers for product identification. The alphabetic identifier (e.g., letters) could be an issue for effective interoperability, because of the different types of alphabets around the world (e.g. the same word could be written in several ways depending on the language).

 

Enable the use of widely accepted international standards

The use of globally accepted standards could ensure interoperability, as well as consistency and uniqueness of the coding between the Track & Trace systems. Currently, GS1 standards are the most widely accepted international standard for identification of pharmaceuticals data. For the moment, the recommendations do not oblige the use of a single global data standard.

 

Use the four data elements

Under “use the four data elements”, it is meant to be the unique product code, the unique serial number, expiry date and batch/lot number. The serialization of the pharmaceuticals is the core of the counterfeiting of medicines and ensuring safe access to healthcare system. The global use of these “four data elements” allows the automation of business processes that require such information for input.

 

Provide clear requirements on packaging level identification

The next logical step of the track & trace process after serialization is the aggregation. The aggregation is realized on case/ bundle level and requires unique identification on both “participants in the process”. The report recommends a clear and harmonized (according to the different countries) guidance on identification and barcoding of the different packaging levels.

 

 

 

#2 Recommendations regarding the data carriers, data fields and syntax

 

Use ISO/IEC Data Matrix on secondary packaging

On the international level, the ISO/IEC 16002 Data Matrix continues to be used globally. The standardized 2D barcode data carrier provides the required information thanks to which the traceability provides visibility across the supply chain. Regarding the standard for secondary packaging, the reports outlined the need for in-depth analysis of AIDC (Automatic Identification and Data Capture) and more specifically its use in place of or in the existing solution.

 

The use of scratch-off mechanisms

One of the things that the report does not support and recommend is the use of scratch-off mechanisms. In the experts` opinion, this technology costs a lot for the manufacturers, but meantime does not have such positive impact on the security of the system.

 

Avoidance of RFID

Because of the difference between the barcode and RFID technologies, the implementation of RFID would entail the use of another data capture device – RFID reader. However, if you choose to use RFID in your production, it is recommended to 2D/Matrix data carrier as a backup of the RFID – in cases of interoperability with countries that do not mandate RFID.

 

Avoid mandating the use of 2D/Matrix bar code other than ISO/IEC Data

As we outlined, the regulatory authorities on a global level require the use of Data Matrix for product identification. The report militates against additional data carriers on the asame package/ label, because of the risks of inefficiency and errors.

 

Human-readable information – “irreplaceable”

The serialized data in the form of barcode is as important for the global Track & Trace, as the human-readable information is for the patients. These two product information carriers are not interchangeable.

 

Use a globally standardised syntax

The scanning devices and their ability to read in interpret are the basis of accurate data reporting to the national regulatory authorities. The globally standardized syntax ensures these devices and their effective and proper way of working.

 

Avoid additional information in the barcode

The place for additional information as a price is not in the barcode. The report reference and recommend that “extra” data could be stored as master data or looked up in IT systems with the use of product code.

 

Use suitable barcodes for each packaging level and avoid multiple barcodes on the same pack

To ensure interoperability, the suitable barcode should be used at each packaging level, afterwards to be used globally.

 

Use only ONE barcode on a pack

Last, but not least – in order to prevent confusion and errors, the use of one barcode on a pack is recommended.

 

As the report clarified “It is important to note that the common denominators identified in these recommendations are a prerequisite for interoperability but are not enough on their own to guarantee full interoperability across traceability systems.”

 

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If you need more information regarding the interoperability of Track & Trace system, schedule a meeting with our experts >>

 

Source:

http://www.icmra.info/drupal/sites/default/files/2021-08/recommendations_on_common_technical_denominators_for_T&T_systems_to_allow_for_interoperability_final.pdf