1 May 2019 – Master Data – The requirement to submit the product information to the BrandSync Portal is part of the Medicines Barcoding and Serialization Guideline.
31 December 2019 – Serialisation SSU – All Products must be labeled in compliance with Legislative Decree No. 41 of 2017.
1 January 2021 – Registration – Register in the NHRA-MVC Traceability Hub, which requires a signed Participation Agreement with NHRA-MVC.
1 January 2022 – Reporting – All Invoicing Companies representing Manufacturers/MAHs are required to fully report traceability events.
1 May 2022 – Aggregation – All Invoicing Companies representing Manufacturers/MAHs are required to be compliant with Aggregation reporting requirements.
Who is affected?
- The manufacturer or their CMO
- Wholesaler and Distributor in the Kingdom of Bahrain
- Hospital or Pharmacy in the Kingdom of Bahrain