An increasing number of countries worldwide have enacted regulations mandating serialization, tracking and tracing of pharmaceutical products down the supply chain during recent years as a response to drug integrity concerns.
There are plenty of laws requiring pharmaceutical companies selling prescription drug products – and over-the-counter products (OTCs) in some instances – to serialize each individual and sellable drug unit to aid authentication and tracking from manufacturing to delivery to patients, e.g.:
- United States’ Drug Supply Chain Security Act (DSCSA of 2013), started to be implemented in November 2017
- European Union’s “Falsified Medicines Directive” (Directive 2011/62/EU), applicable since February 9th, 2019.
To avoid the risk of non-compliance as this regulatory requirement spreads worldwide, it is necessary for the pharmaceutical companies to clarify serialization regulations in any country they intend to serve. Thus, what follows is an overview of the serialization requirements in the Middle East and North Africa (MENA) region with a focus on Saudi Arabia.
The Situation in Saudi Arabia
The Saudi Food & Drug Authority (SFDA) believes that a “standardized identification system from manufacture to patient delivery is imperative to comply with the increasing need for product integrity and traceability”.
Therefore, SFDA requests both international drug manufacturers exporting to Saudi Arabia and local manufacturers to implement GS1 supply chain standards. The reasoning behind opting for the GS1 system is that it has been endorsed by the global healthcare community and is one of the most widely used trade item identification systems worldwide.
To provide guidance to the industry, the Drug Sector at the SFDA has issued the “Drug Barcoding Specifications” guideline (current version 6.1 of October 1st, 2019) which details the requirements for the Saudi market.
In the view of the Saudi regulator, the aims of implementing serialization are to enhance patient safety, reduce medication errors and enable tracking of each drug unit in the supply chain. The functioning standardized identification system will lead to:
- Effective detection of counterfeits
- Proper traceability and fast product recalls and withdrawals
- Accurate, real-time information flow among stakeholders
- Continued support for the optimal use of the drug.
Requirements for Saudi Arabia: GS1 Data Matrix 2-D Barcode, Printed Information and Aggregation
GS1 Data Matrix 2-D Barcode
The GS1 Data Matrix barcode is a graphic representation of digital data in a two-dimensional format. It can be read by camera-based barcode scanners and offers a high-storage capacity that permits encoding for a larger amount of data within a smaller space when compared to linear barcodes. Data Matrix enables direct marking for items where it is impractical to add a label. Accordingly, linear barcodes must be upgraded to GS1 Data Matrix 2-D Barcodes (Figure 1).
Figure 1: Example of Linear Barcode and GS1 Data Matrix 2-D Barcode
SFDA requires that the GS1 Data Matrix barcode must include at a minimum:
- The GS1 Global Trade Item Number (GTIN)
- The serialization number (SN)
- The expiration date in YYMMDD format and
- The batch/lot number.
|FNC opening character||AI||GTIN||AI||Serial number||FNC separator||AI||Expiration date||AI||Batch number|
Figure 2: Example of the required information in the GS-1 DM barcode and how it appears when read by the scanner
AI. In addition, each item must provide its Application Identifier (AI) – an opening code of two, three or four digits placed at the beginning of the GTIN to identify and differentiate it from a serial number.
GTIN. The GTIN is a globally unique number used as an identifier for trade items, products and services worldwide. There are several lengths for GTINs but SFDA accepts the GTIN-14 – a 14-digit number that should be encoded in the Data Matrix barcode.
Local companies have to register at GS1 Saudi Arabia to acquire a GS1 Company Prefix, be able to produce GTINs and access the GS1 standards.
SN. The serialization number (SN) is used to identify each product unit. A used SN cannot be reused again for the same product. The SN can be up to 20 alphanumeric characters in length and must be randomly generated by the manufacturing company.
FNC1. The Function 1 Symbol Character (FNC1) is a “separator used as a barrier in between different data entry components that do not have a fixed character count”, e.g., between serial numbers and batch numbers. The FNC code entered after each one of the data entries informs the scan reader that their number has ended.
SFDA accepts and offers several label printing options. The one shown below (Figure 3) opts for printing only the GTIN and SN without the lot number or expiry date. In this case, the latter two information points must be printed on the outer packaging of the pharmaceutical product.
Figure 3: An accepted option for the printed information
Aggregation, as described in the SFDA guideline, “defines the hierarchy relationship between the parent and child where each of the packaging levels will be barcoded allowing the receiver of the product to scan one code and understand exactly what is in the whole shipment—every case, bundle, or individual carton”.
SFDA mandates that aggregation is done by manufacturers for the various packaging steps of the supply chain according to GS1 standards. All details on how to complete aggregation can be found in the published guideline.
Ensuring compliance with the barcoding and aggregation requirements
SFDA recommends Saudi Arabia based companies to contact the GS1 Saudi Arabia office to obtain GTINs, GLNs, aggregation standards, and Data Matrix barcodes.
Manufacturers should have proper procedures in place to handle the aggregation process and manage its files following GS1 standards for products shipped to other parties. In addition, the production lines must be prepared to print and verify the new barcodes.
Products that require barcoding
All human drugs intended to be placed on the Saudi market require barcoding according to the SFDA guideline. In the next step, this will apply also to veterinary drugs as well as to herbal and health products. Exceptions are made only for:
- Free samples
- Non-registered drugs ordered for specific patients
- Drugs cleared for personal use
- Drugs that must be repackaged – non-finished products.
Drugs Barcoding and Serialization in MENA
Following the global trend, other Competent Authorities in the MENA region have also started mandating medicines barcoding and serialization.
The table below summarizes the status of the GS1 2D Data Matrix barcode requirement (related to the addition of GS1 2D barcode that includes a batch number, expiry date and GTIN) and serialization implementation dates (related to the addition of a serial number per box to be included in the GS1 2D barcode) in selected MENA countries:
|Country||GS1 DM 2D Barcode||Serialization|
|Algeria||– Not yet required||– Not yet required|
Deadline for implementation: December 31st, 2019
Deadline for implementation: December 31st, 2019
|Egypt||December 2018 (at least 1 product per distributor)||December 2018 (at least 1 product per distributor)|
|Iraq||– Not yet required||– Not yet required|
|Jordan||December 31st, 2019||December 31st, 2019 (grace periods are possible)|
|Kuwait||– Not yet required||– Not yet required|
|Lebanon||January 1st, 2020 (imported)
December 31st, 2022 (local)
|– Not yet required|
|Oman||March 1st, 2019||March 1st, 2019 (grace periods are possible)|
|Qatar||January 18th, 2021 (required by HMC*)||January 1st, 2021 (required by HMC*)|
|Saudi Arabia||May 15th, 2015||March 12th, 2017;
Aggregation – August 20th, 2020
|United Arab Emirates||Required by some institutions only:
· CCA** – since January 18th, 2021
· BDHA*** – since January 17th, 2021
|Deadline for implementation: June 1st, 2021|
HMC* – Hamad Medical Corporation; CCA** – Cleveland Clinic Abu Dhabi; BDHA*** – Dubai Health Authority
Drugs barcoding and serialization have become an important regulatory requirement in major MENA markets. The remaining countries in the region are expected to follow suit and introduce the mentioned requirements sooner or later.
Barcoding and serialization are often viewed as more than a regulatory requirement to meet – companies invest in and leverage barcoding and serialization to increase efficiencies, fight the proliferation of counterfeit drugs by securing supply chains, improve inventory visibility, product recalls, etc. Failing to achieve compliance with these regulations can have significant business and financial implications as well.
Therefore, pharmaceutical companies selling or planning to sell to the region should inquire about existing barcoding and serialization regulations, clarify the requirements and implement necessary changes to their product labeling processes.
If you want to inquire on this or other regulatory topics related to the MENA region, contact us!