Regulatory Requirements

Drug Serialization and Aggregation in Saudi Arabia: Latest Updates

The Adents Team Written by The Adents Team
21-Aug-2019

Drug Serialization and Aggregation requirements in Saudi Arabia have been further clarified. Indeed, spring 2019 was a very busy time for the Saudi Food & Drug Authority (SFDA), culminating in the publication of V 6.0 of the Saudi Drug Barcoding Specifications (published in July), and two new guidelines in June.

New guidelines on Saudi DTTS e-services

Two new guidelines explain how to register with and use the Saudi Drug Track & Trace System’s (or in short DTTS) e-services Stakeholder Management Portal and Stakeholder Operation Portal.

In the Stakeholder Management Portal, licence holders manage their DTTS stakeholders like manufacturers, suppliers, warehouses, hospitals or pharmacies. To get registered, each user will need a GS1 GLN (Global Location Number). The system will create a user name for each stakeholder to login and notify the system about the operations in the stakeholder operation portal.

Through the Stakeholder Operation Portal, establishments and their stakeholders report movements of drugs in the supply chain. The portal can be used to some extent as a communication tool. For instance, upon acceptance of a shipment, a user can rate delivery speed and package quality. 

Serialization and coding requirements in Saudi Arabia clarified

Serialization requirements are applicable since March 2017 for medicines for human use that are ‘packaged and ready to be marketed’. There are plans to include drugs for veterinary use as well as herbal and other health products in the future. To create serial numbers, pharmaceutical companies do not have to coordinate with third parties or government agencies. Therefore, they can manage the generation of serial numbers in-house. To be compliant with Saudi serialization requirements, serial numbers must be unique to each unit and generated in a randomized manner. Allowed are combinations of up to 20 letters and digits (Alphanumeric). The human-readable serial number must match the serial number encoded in the GS1 Datamatrix.

Saudi Arabia uses GS1 standards: GTIN 14 is used as product code. This 14-digit Global Trade Item Number (GTIN) can be used to identify trade items at various packaging levels: the first digit indicating the packaging level, the next twelve digits the GS1 Company Prefix and the item reference assigned by the manufacturer in addition to a check digit at the end.

The GS1 Data matrix to be printed on secondary packaging is to include Global Trade Item Number (GTIN), expiry date (6 digits, YYMMDD format), batch and serial numbers.    

From October 2019, aggregation will be mandatory in Saudi Arabia; using the 18-digit Serial Shipping Container Code (SSCC) on cases/cartons and pallets, whether homogenous or heterogenous. The SSCC needs to be encoded in a 128 linear barcode or Datamatrix (both GS1 standards). For homogenous cases and pallets, a Datamatrix including a higher level GTIN, expiry date and batch number can be used in addition (not instead!).

Serialization requirements around the world

The Adents Team
The Adents Team

The Adents Team: your serialization experts. With over 25 years of experience in different fields of product traceability, supply chain, big data and pharmaceutical serialization, our team members bring a wealth of knowledge to help you better understand the challenges and opportunities of serialization.

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