Regulatory Requirements

Saudi Arabia: Compliance Deadline is Now

The Adents Team Written by The Adents Team
07-Jan-2019

The Saudi Food & Drug Authority (SFDA) requested that by the January 7, 2019 deadline all stakeholders (manufacturers, warehouses, pharmacies, medical and dispense centers) register and start reporting all transactions for drug packages placed on the Saudi market to Drug Track & Trace System (DTTS).

The SFDA website content was recently updated to include the latest versions for the DTTS Integration Guide  (published on October 24, 2018), Drug Barcoding Specifications (published on November 29, 2018) and new Stakeholder Management Portal Manuals for track and trace system (published on November 25, 2018).

While January 7th is already here, the industry is reporting various levels of readiness. It is not always clear whether reporting to DTTS can be done when products are originating outside of Saudi Arabia and the manufacturer has no registered facilities in the country. We recommend that manufacturers reach out directly to SFDA and their local Saudi agents/distributors to identify what they need to do to be compliant with track & trace/reporting requirements. Manufacturers importing their products to the Saudi market need to be able to provide serialization data to their agent company in the country. Without the receipt of data, the alternative for the local agent/distributor will be to scan all products manually to build the dataset for reporting.

Saudi requirements follow GS1 standards and cover all pharmaceutical products placed on the Saudi market, including OTC medicines. Free samples, nonregistered drugs ordered by hospitals for specific patients and in particular quantities, as well as drugs cleared for personal use and drugs cleared for repackaging purposes are exempt.

In order to be compliant with Saudi regulations, manufacturers need to be able to print a GS1 DataMatrix code on secondary packaging. At a minimum DataMatrix is required to include the following data elements: GTIN (GTIN14), expiration date (YYMMDD format), batch/lot number and serial number (variable length up to 20 alphanumeric characters, unique for a given GTIN). 

For details on what is required to be printed on the outer packaging, please refer to the Drug Barcoding Specifications document on the SFDA website.

As for aggregation, while not required, it is recommended by the SFDA. In track & trace systems where reporting to DTTS is to be done by each supply chain participant, aggregation and the ability to infer the contents of the outer packaging, becomes especially important when dealing with serialized products.

Companies that have invested in robust serialization solutions will have less hurdles to overcome. Contact the Adents team to learn how we enable global compliance in the world of continually changing regulations.

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.

DISCOVER MORE ...

EU FMD: new FAQ document gives guidance on safety features for medicinal products
EU FMD: new FAQ document gives guidance on safety features for medicinal products
The EU commission has released version 16 of the FAQS related to the EU Falsified Medicines Directive including recommendations on coding requirements and serial number generation.
FDA delays Product Identifier verification requirement for saleable returns
FDA delays Product Identifier verification requirement for saleable returns
The FDA issued a compliance policy guidance for Wholesale Distributor Verification Requirement for Saleable Returned Drug Product in the US. The deadline is now November 27th 2020.