Saudi Arabia Regulatory Compliance

General Overview

The Saudi Food and Drug Authority (SFDA) was established under the Council of Ministers resolution no (1) dated 07/01/1424 H, as an independent body corporate that directly reports to The President of Council of Ministers. The Authority objective is to ensure safety of food and drug for human and animal, and safety of biological and chemical substance as well as electronic products.

The Saudi Food & Drug Authority initiated Drug Track and Trace System for pharmaceutical products (RSD) as one of its plans to contribute in achieving the kingdom’s Vision 2030 by adopting new technologies for tracking all human drugs manufactured in Saudi Arabia and imported from abroad.

In 2019 the Saudi Food & Drug Authority (SFDA) required all supply chain actors to register at their portal ASAP. Requirements for reporting to start Jan. 7, 2019.

Aggregation applies to all local manufacturers. If global manufacturers export without aggregation, local agents should do it on their behalf. The SFDA aggregation requirement means that all saleable units must have an identity or data relationship to the case they are shipped in.

Every registered drug in the Saudi market is assigned a Saudi Drug Code (SDC) that contains four variables: a fixed prefix, the year, a letter to identify the type of drug, and a serial number (e.g., SFDA12D001). The SDC will eventually replace the current code.

Regulatory Framework

Products that require barcodes:

Human drugs that are packaged and ready to be marketed;
Herbal and Health products that are packaged and ready to be marketed will require barcoding in the future;
Veterinary pharmaceutical products that are packaged and ready to be marketed will require barcoding in the future.

Products that does not require barcodes:

Free samples of pharmaceutical products;
Nonregistered drugs ordered by hospitals for specific patients and in particular quantities;
Drugs cleared for personal use;
Drugs cleared for repackaging purposes.