March 2017 – Serialization SSU – All Products must be labeled in compliance with Legislative Decree No. 41 of 2017.
February 2018 – Registration DENR – All local manufacturers and warehouses have to register their GLN’s in the DENR authority portal. Do not apply for overseeing suppliers.
7 January 2019 – Reporting DTTS – Stakeholders start reporting SNs through the new authority platform called DTTS, Drug Track & Trace System.
August 2020 – Aggregation – All Companies representing Manufacturers/MAHs are required to be compliant with Aggregation reporting requirements.
Who is affected?
- Medical and Dispense Centers
Local manufacturers and importers/distributers have to notify the authorities through DTTS about all activities done to the drug packs.
The external manufacturers (oversee suppliers with production outside the KSA) have the possibility to provide their agents with a flat list of SN.