Regulatory Requirements

Drug Serialization Requirements in Saudi Arabia

Brigitte Naftalin & Nathalie Wardé Written by Brigitte Naftalin & Nathalie Wardé
17/03/2017

The Saudi Food and Drug Authority (SFDA) has published the latest version of the Saudi Drug Code (SDC) in November 2016. Its aim is to fight against counterfeit pharmaceuticals and to make Saudi Arabia’s drug supply chain safer and more efficient.

If you are producing for the Saudi Arabian market, you need to be aware of the SDC to ensure your pharmaceutical products are cleared and get import permits through the Import and Batch Release Clearance System (IBRCS).

Benefits for the Saudi Supply Chain

The main objectives of the Saudi Drug Code are to increase patient safety, reduce medication errors, detect counterfeit pharmaceuticals, facilitate product recalls and withdrawals and ensure accurate, real-time information flow among stakeholders. The benefits of drug serialization are numerous, and not limited to the customer. Hospitals can reduce adverse drug events by verifying the origin and ingredients of genuine drugs. Pharmacies, distributors, wholesalers and even manufacturers benefit from a healthy supply chain as well.

Scope of the Saudi Drug Code

Since March 2017, all pharmaceutical products for human treatment that “are packaged and ready to be marketed” (i.e. Rx and OTC drugs, food supplements, herbal products) have to be serialized and assigned with a GS1 Data matrix barcode. Veterinary products will follow, however, there is no specific application date yet. Exempt are free samples, non-registered drugs manufactured in limited quantities for hospitals for specific patients, as well as drugs that are to be repackaged (after clearance).

Coding requirements for the Saudi Arabian market

To ensure the quality and overall readability of information provided, Saudi Arabia has decided to adopt GS1 standards. Published in November 2016 by the Saudi Food and Drug Authority, the Saudi Drug Code (SDC) and Drug Barcoding Specification provides further details regarding coding requirements that have to be taken into account as of March 12, 2017. Pharmaceutical companies and CMOs have to provide certain information in human-readable and GS1 Datamatrix format on the secondary packaging.

Serial numbers and GS1 standards in Saudi Arabia

To facilitate international understanding, the secondary packaging of a drug destined for the Saudi Arabian market must contain the 14-digit GS1 Global Trade Item Number (GTIN). The IBRCS will use the GTIN to identify and track the pharma product entering Saudi market. GTIN-14 is a 14-digit number used to identify trade items at various packaging levels: the first digit indicating the packaging level, the next twelve digits represent the GS1 Company Prefix – GCP and the item reference assigned by the manufacturer plus a check digit. It is the pharmaceutical company’s responsibility to contact GS1 to obtain its unique Global Location Number (GLN).

The serial number

The Saudi Drug Code (SDC) and Drug Barcoding Specification indicates that pharmaceutical companies do not have to coordinate with third parties to obtain their serial numbers. Therefore, they can manage the generation of serial numbers in-house as long as the serial number is unique to each unit and does not exceed 20 digits. Allowed are combinations of letters and digits (Alphanumeric). The human-readable serial number must match the serial number encoded in the GS1 Datamatrix.

Together with unique product identification or serial number and Global Location Number, drug manufacturers have to print expiration dates in YYMMDD format and batch/lot number on the packaging.

There are multiple options on what to print and where on secondary packaging. For details please refer to the Saudi Drug Code (SDC) and Drug Barcoding Specification as published by the SFDA on November 17, 2016.

Aggregation and national drug database

Over time, all registered drugs’ GTIN numbers will be collected in order to add them to a periodically published drug database on the SFDA’s website. Each registered product in the database is going to carry a GTIN and a SDC number. There are currently no specific information or deadlines regarding potential aggregation requirements. However, it is likely that aggregation will, at one point, have to be put in place to comply with potential upcoming regulations.

What next in the Middle East?

Once the Saudi Arabian approach has been tried and tested, other members of the Cooperation Council for the Arab States of the Gulf (CCASG) or Gulf Cooperation Council (GCC) will probably follow its example. In Jordan, serialization will be mandatory from 2020 whereas Egypt and the United Arab Emirates are working on draft laws implementing serialization based on GS1 encoding for global interoperability. Regulations are also expected for the Lebanese market.

Brigitte Naftalin & Nathalie Wardé
Brigitte Naftalin & Nathalie Wardé

Brigitte has an extensive background in journalism, marketing and international business. During her travels in Africa and South-East Asia, she has learned first-hand about the importance of malaria drugs and was shocked about the percentage of counterfeit medicines in certain countries. Brigitte has joined Adents’ marketing team in July 2016 to be able to contribute to a safer drug supply chain through serialization.

Nathalie works as an independant consultant based in Switzerland. With more than 20 years of experience in Pharmaceutical Manufacturing Operations, she is specialized in Supply Chain Project Management, Contract Manufacturing, Compliance to GMP/GDP and international Track&Trace regulations especially in the MENA region and in Europe.

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