Introduction
Pharmaceutical drug serialization regulation is drafted and governed by Jordan Food and Drug Administration (JFDA). The regulatory requirements were introduced to ensure the implementation of serialization and traceability systems in the pharmaceutical supply chain. These regulations are in line with international standards and best practices.
The serialization systems implemented in JFDA are designed to be interoperable with systems in other countries, facilitating the global movement of pharmaceutical products.
Key areas of regulation requirements as per JFDA:
Regulations: The JFDA has established regulatory requirements for pharmaceutical serialization in line with global standards, including those from organizations like the World Health Organization (WHO) and the Drug Enforcement Administration (DEA).
Serialization Standards: Pharmaceutical manufacturers and distributors in Jordan are required to adhere to specific serialization standards, such as GS1 global standards, to ensure the unique identification of each product.
Data Management: The serialization process involves capturing and managing data related to each serialized product, such as product information, batch numbers, expiration dates, and unique serial numbers. This data is typically stored in a central repository or database.
Traceability: The serialization system enables tracking and tracing of pharmaceutical products at various points along the supply chain, from manufacturing to distribution and dispensing.
Verification: Pharmacists, wholesalers, and other stakeholders in the pharmaceutical supply chain can verify the authenticity and legitimacy of products using the serialized codes.
Note of caution from JFDA: Pharmaceutical companies operating in Jordan are required to comply with serialization regulations, and non-compliance can lead to regulatory actions and penalties.
Timelines:
The JFDA was created in 2003 to ensure the safety and efficacy of drugs and the quality and safety of food. After postponing the implementation of 1D linear and 2D data matrix codes several times in recent years, the JFDA has now established new regulations for the application of 2D data matrix codes and serialization on secondary packaging of pharmaceutical products. Since 2018, every pharmaceutical product must be provided with a DataMatrix. By 2020, these products should be labelled with a DataMatrix and additionally need to be serialized. However, the deadline has been postponed several times, which means that this requirement was scheduled for September 30, 2023.
Product Identification
To facilitate the visual correct reading control together with a two-dimensional bar code is applied Human-Readable Information (HRI), which includes the following elements:
- GTIN: Maximum 14-digit code for unique identification of products at the global level.
- Batch number: Maximum of 20 alphanumeric characters.
- Expiration date: Represented in YYMMDD.
- Unique Serial number: The length of the serial number is variable and can contain up to 20 alphanumeric characters.
Compliance
It is important for pharmaceutical companies to work closely with their supply chain partners and technology vendors to ensure that their serialization solutions comply with JFDA regulations and meet the required deadlines. Non-compliance with serialization requirements can result in penalties and delays in product registration and market access in Jordan.
How can CosmoTrace help?
We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing them for the existing and upcoming regulations across the globe.
We are well versed with the compliance regulations for various markets and can help you with implementing the Jordan pharmaceutical serialization requirements.
Our team of experts strategize and plan end-to-end solutions using a combination of years of knowledge in product serialization, pharmaceutical supply chains, life sciences and brand integrity.
Disclaimer
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions. Please use the references below to follow the updates at the source.
