Key Track-and-Trace Requirements of New NHRA Bahrain Guidelines for Pharma Manufacturers

Approximately two billion people worldwide lack access to necessary medication and vaccines, according to the World Health Organization. Unfortunately, such a vacuum is often filled with falsified or substandard products.

The problem is exacerbated primarily by two factors. Firstly, healthcare supply chains have become too complex. Today, it’s possible for a product manufactured in one country to be packaged in another country and sold in a third. Secondly, the growth of e-commerce has made it easy for consumers to purchase “medication” online, often from unauthorized sources.

Counterfeit drugs can harm not only the user’s physical and mental health, but also their financial health, and erode their trust in the healthcare system.

Fortunately, many national governments have taken active steps to address the issue. For instance, the Kingdom of Bahrain has pledged to create a complete track-and-trace system to curb the growing problem of drug falsification.

Pharmaceutical manufacturers or packagers that are based in Bahrain or have trade relations with the country need to know about the new National Health Regulatory Authority (NHRA)’s track-and-trace guidelines.

ROLE OF THE NHRA IN COMPLIANCE

The NHRA is a licensing body in Bahrain that decides whether a manufacturer is fit to produce and sell drugs. Individual manufacturers have to go through rigorous NHRA checks to sell their medicines. Professional healthcare workers also have to acquire an NHRA license to set up their practice, and the organization oversees clinical trials.

Recently, the NHRA has been working to develop an end-to-end track-and-trace system to deter drug counterfeiting.

WHAT IS THE NHRA TRACEABILITY HUB?

To realize their vision of end-to-end traceability, real-time transparency, accountability, and verification, the NHRA devised a data repository and track-and-trace application known as the NHRA-MVC traceability hub.

Pharmaceutical manufacturers and intermediary vendors must submit traceability and serialization information to the hub to facilitate enhanced product visibility and to protect the integrity of the supply chain.

With such a system in place, the NHRA and supply chain stakeholders will be able to:

  • Accurately detect counterfeits
  • Eliminate medication errors
  • Ensure enhanced traceability
  • Initiate faster product withdrawals and recalls
  • Facilitate real-time information flow between stakeholders

So, how does it help supply chain stakeholders? Distributors, manufacturers, importers and others must complete the technical onboarding process to validate their readiness in sharing transactional information. They must send records of transactions to the traceability hub, such as:

  • Receiving a shipment of serialized medicine into stock
  • Packaging (aggregation of cartons to cases and cases to pallets)
  • Shipping products to various dispensers (hospitals, clinics, pharmacies)

Though this adds an extra step to the process, it will help the pharmaceutical supply chain in the long run. How? Easily accessible data facilitates package location, inventory planning, demand forecasting, recall effectiveness and more.

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CHRONOLOGY OF NHRA TRACEABILITY PROGRESSION

For seamless incorporation of the track-and-trace program, the NHRA proposed a five-year timeline, starting in November 2017 and ending in May 2022. Here are some of the key milestones manufacturers, packagers and distributors need to be aware of:

November 2017 : This month marked the inception of track-and-trace regulations in Bahrain. Manufacturers and other supply chain stakeholders must now assign Global Trade Item Numbers (GTINs) to all drugs supplied in Bahrain.

April 2018 : As of April 2018, manufacturers have to report product master data to the GS1 UAE BrandSync Portal.

December 31, 2019 : From this day onwards, all Marketing Authorization Holders (MAHs) must be registered on the MVC (Medical Value Chain ) traceability hub and registered product master must be uploaded to Brandsync before importing the Goods to Bahrain.

October 2021 : All MAHs must be certified by October 2021. Also, they must begin actively sharing shipment information with the traceability hub.

May 2022 : This marks the deadline for supply chain players to comply with aggregation requirements.

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PRODUCTS AFFECTED BY THE REGULATIONS

The following pharmaceutical products are subject to the new regulations:

  • Medicines that are produced by foreign companies and imported as finished goods
  • Non-registered medicines having a temporary importation license
  • Imported medicines that are locally repackaged

GUIDELINES FOR SERIALIZATION IN BAHRAIN

Serialization allows manufacturers and other stakeholders to keep track of every product moving through the supply chain. The unique identifier that is logged into the system of every supply chain stakeholder, as well as with the NHRA, allows no room for counterfeit products.

All pharmaceutical manufacturers must provide labeling for products in line with GS1 standards. Pharmaceutical trade items also must carry a 14-digit GTIN. Using standardized GTINs will empower the worldwide pharmaceutical industry to make consistent decisions to identify pharmaceutical products throughout the supply chain.

When paired with other relevant data, such as the batch number (up to 20 characters), expiration date (up to 6 characters) and serial number (up to 20 characters), this interoperable system will provide end-to-end traceability – from production to patient delivery – to every pharmaceutical supply chain stakeholder.

GS1 standards also dictate that GTINs, expiration dates, serial numbers, batch numbers need to be included in one barcode. This makes it easy to feed information to the repository, as opposed to typing in 20-character numbers.

Moreover, when you scan the barcode, the data is automatically verified against the information provided by the entity one level below in the supply chain. This makes it easy to track your products and identify missing or fake products.

The Datacode must also be printed in Human Readable Interpretation (HRI) format. One can print the HRI below or on the side of the barcode. It’s particularly helpful in case the scanner is having trouble reading the barcode.

HRI information must carry an Application Identifier (AI) to help packagers along the supply chain understand what the number signifies. Here are the four most commonly used AIs:

  • GTIN: 01
  • Serial Number: 17
  • Lot Number: 10
  • Expiry Date: 21

The AIs follow global GS1 standards.

SCOPE OF AGGREGATION IN NHRA BAHRAIN GUIDELINES

Aggregation is the end goal of NHRA’s track-and-trace guidelines. If you’re unfamiliar with the term, aggregation is a form of hierarchical serialization that facilitates granular tracking of medical products.

Aggregation won’t be mandatory until May 2022; however, end-state aggregation is still required at the time of shipment.

From May 2022, the NHRA will require item, case, and pallet serialization. Each saleable item will need a unique serial number, as will the case it’s packed in and the pallet on which the case is stacked. Aggregation defines a parent-child relationship between each packaging level.

kind of hierarchical relationship. The same goes with the carton and the pallet it’s stacked in.

Here are some benefits of chain-wide aggregation:

  • Repackagers and suppliers no longer need to scan every individual product, as scanning the parent will automatically log in all data about its contents.
  • As all countries are slowly moving towards aggregation, adopting it will help you remain trade-ready.
  • As each parent node has all the data regarding its child components, it’ll be easy to detect any anomalies and mismatches and prevent the entry of counterfeit or illegal drugs into the pharmaceutical supply chain.

The NHRA requires manufacturers, packagers and suppliers to include GS1-standard Serialized Shipping Container Coding (SSCC) during aggregation, with a maximum five-level hierarchy.

WHAT ARE THE DATA REPORTING REQUIREMENTS?

Not all information is to be reported to the traceability hub:

  • Only packing events need to be reported
  • Operational events in the warehouse do not need to be reported
  • Unpacking events do not need to be reported

A thorough understanding of the guidelines will ensure that any pharmaceutical manufacturer or packager based in Bahrain can continue selling and producing drugs.

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