Key upcoming updates for Bahrain Traceability

December 2021 – End of 90 day grace period to Invoicing Companies, MAHs and exporting distributors in submitting reports to the NHRA-MVC Traceability Hub. 

Exception Period 1st October 2021 - 31st December 2021

All invoicing companies (MAHs, Manufacturers, Exporting Distributors)

  • Shipments between1st October and 31st December, 2021; shipment information would need to be reported as done in the past and NHRA will exempt these shipments for reporting the serialization information.
  • This is a 3-month grace period ending 31st December, 2021 to help address present supply chain challenges.
All Agents/Distributors (Importers), Dispensers (Hospitals, Pharmacies, Clinics) in the Kingdom of Bahrain
  • Medicines received in the inventory prior to 1st October, 2021 will not show up in the NHRA-MVC Traceability Hub if the serialization information is scanned.
  • Medicines received between 1st October, 2021 and 1st December, 2021 may not show up when serialization information is scanned due to the pandemic-related global supply chain challenges.

October 2021 – MAHs to be certified and reporting shipment information to the MVC Traceability Hub.
May 2022 – Aggregation to become mandatory

The MAH that export products to Bahrain are required to comply with the new reporting requirements given by the kingdom. There are certain changes also if you are an invoicing company, shipping & manufacturing company or both. For more information and to check your readiness, visit our Bahrain page.

Introduction to NHRA

The National Health Regulatory Authority in Bahrain plays a key role in ensuring expected health standards are met. This guarantees that patients are provided with safe drugs and can access the best form of medical care. The NHRA is an independent sector that regulates the entire healthcare system in the Kingdom. It has effective regulatory procedures that involve the licensing of all parties involved in the healthcare business such as pharmaceutical centers and hospitals. The NHRA has implemented a blockchain based end to end traceability hub which is the first of its kind in the GCC.

NHRA’s role in Bahrain’s Regulatory landscape

It provides licenses for the pharmaceutical factories in order to allow them to produce and supply drugs. The manufacturers also have to go through the NHRA in order to have their new drugs registered and then be provided the mandate to sell their products. As a licensing function, the NHRA is also involved in providing licenses to healthcare professionals. As a way of acting as a voice for the patients, the NHRA also takes part in regulating the general prices of drugs and also investigating any form of misconduct done by any healthcare professional. In addition to such fundamental and necessary roles, the NHRA also accepts and declines approvals when it comes to conducting clinical trials.

NHRA Bahrain’s Traceability Hub Highlights

  • Meets global track and trace requirements
  • Adheres to GS1 standards
  • Provides end to end traceability of all medicine imports into Bahrain
  • Clear visibility of medicine inventory right from manufacturers to patients and all intermediate transfers
  • Provides analytics of medicine imports and usage.
  • Increased patient safety by detecting and stopping counterfeit medicines.

Fundamental guidelines for Traceability in Bahrain

  • GS1-standard barcode to the medicines which are in-scope for Serialization, including human-readable data elements.
  • Provisioning and commissioning of a unique serial number at the individual unit at the POS.
  • Reporting to the Bahrain Traceability Hub – NHRA-MVC
  • Recording and traceability of commissioning, aggregation, and the shipping events
  • During the initial phase, Marketing Authorization Holders (MAHs) and Invoicing Companies must register and report all the medicines which fall under the scope with the NHRA.

The products which will be governed by the regulations

  • Foreign-produced medicines imported as finished goods
  • Imported medicines that are re-packaged locally
  • Non-registered medicines with a temporary importation license
  • Reporting responsibility lies with the invoicing company.
It’s important to note that the regulations do not make any provision for allowing 3rd parties do the reporting part with MVC Hub on behalf of an MAH.

Important past milestones

  • Bahrain legalized the Track and Trace regulations in Nov 2017
  • Starting April 2018 the product master data was reported to GS1 UAE BrandSync portal
  • Barcoding and serialization were adopted starting December 2019
  • THe MAH registration to the MVC hub started in January 2021

Aggregation

Product aggregation is still optional in Bahrain until May 2022 but End-state aggregation at time of shipment is still needed. The following aggregation rules related to reporting and GS1 standards still apply at the time of this writing:

Reporting requirements

Operational events in the warehouse are not needed to be reported.
No unpacking events are expected to be reported.
Requirement is to only report packing events

NHRA requires a maximum depth of 5 levels when aggregating products while following GS1-standard serialized shipping container coding (SSCC) configurations

Adherence to GS1 standards

The NHRA has ensured that all countries supplying and trading with pharmaceutical products meet the GS1 System of Standards. The National Health Regulatory Authority (NHRA) has also mandated the application of GS1 Data Matrix on the packaging of pharmaceutical products.

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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, partners 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.

https://www.nhra.bh/

Reference
AlSaffar, Gardenia. “Ethical Programs for Patients in Bahrain.” Ethical Consumerism and Comparative Studies Across Different Cultures: Emerging Research and Opportunities. IGI Global, 2020. 53-73.
Pascu, Georgiana Andreea, Gabriel Hancu, and Aura Rusu. “Pharmaceutical serialization, a global effort to combat counterfeit medicines.” Acta Marisiensis-Seria Medica 66.4 (2020): 132-139.

NHRA Circular No. (29) 2021

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