Regulatory Requirements

Saudi Arabia Regulatory Update on Aggregation Requirements

Written by The Adents Team

26-Apr-2019

Pharmaceutical manufacturers that supply the Saudi Arabia market are required to serialize drug products since 2017.

A circular recently released in February 2019 furthers the SFDA Track and Trace mission by requiring manufacturers to aggregate product by October 1, 2019.

While it was recommended for manufacturers to aggregate, to date there was no regulatory requirement.

Currently, manufacturers need to provide shipment data to their agents in Saudi Arabia, including the serial numbers of the packages. Local agents are then responsible for reporting that data to SFDA.

The October deadline does not give manufacturers much time to implement aggregation capabilities if they are not already installed.

Adents has posted on what it means to aggregate products, and GS1 has recently published a discussion paper on aggregation.

It’s important that manufacturers prepare to aggregate all products for the Saudi Arabia market as well as to establish data exchange capabilities and expectations with their in-country distribution network.

Serialization in Saudi: Are you all set to address reporting requirements?

Aggregation may streamline inbound and outbound processes for logistics operations, but managing aggregated hierarchies adds a lot of complexity to the IT systems and material management processes.

Also, the SFDA specifically indicates that errors in aggregation need to be fixed by the sender. This issue will no doubt flow upstream to the manufacturer, and it will be difficult to fix aggregation errors once product is in Saudi Arabia. For this reason, it is critical that manufacturers have robust aggregation systems and processes in place.

Adents has posted information on the serialization regulatory requirements in Saudi before. If your company has any questions on readiness or compliance issues, download our comprehensive global serialization regulatory map below.

Take a Look to the Global Serialization Landscape

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 ...

Serialization of medicines in Russia: Deadline is officially extended!

Just before New Year, the federal law No. 346344-7 amending Government Decree 1556 "On approval of the Regulations on the system of monitoring the movement of medicines for medical use" was officially signed and published

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.