SERIALISATION - ARE YOU READY?

SERIALISATION - ARE YOU READY?

An Overview from EU and US perspective:

In 2011, the European Commission published Directive 2011/62/EC, the Falsified Medicines
Directive (or FMD). The FMD is designed to protect patients by minimising the chances of counterfeit medicines entering the established medicines supply chain across Europe.
It will enable manufacturers, wholesalers, distributors and everyone who supplies to patients to verify the authenticity of a medicinal product, identify individual packs, and check whether the outer packaging of medicines has been tampered with. Serialisation is a track and trace method.

The unique identifier includes a 20-character alphanumeric serial  number, product code, batch number and expiry date, as well as national identifying or reimbursement numbers where required.
The 2D barcode (data matrix) has been set as carrier of this unique identifier. The composition, format and carrier of this unique identifier will be fully harmonised across the EU.An end-to-end verification system supported by risk-based verifications by wholesale distributors will guarantee Medicine authenticity. Medicines will be verified before being dispensed to patients. With the end-to-end scanning process of the data matrix, the authenticity of each packaging is automatically verified via a protected centralised database.

If identical numbers are found or if a number cannot be found in the database, an alarm will be triggered immediately.The repository containing the unique identifiers will be set up and managed by the stakeholders. National competent authorities will be able to access and supervise the database.This new requirement will become active in 2018.

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2011_62/dir_2011_62_en.pdf
 
In the US on the other hand, the Drug Quality and Security Act (DQSA) was signed into law on 27 November 2013. It outlines critical steps to build an electronic, interoperable system for
identification and traceability of prescription drugs as they are distributed in the U.S. The new law supersedes any states requirements. The requirements are phased in over a period of 10 years by providing a migratory path from lot traceability to serialisation to item-level traceability. The new system will enable verification of the legitimacy of the drug product identifier down to the package level, enhance detection and notification of illegitimate products in the drug supply chain and facilitate more efficient recalls.
 
In summary, there are planned implementation time frames for the Drug Supply Chain Security Act over a 10-year period.

The major phases are:

  • Lot-Level traceability and verification: Phase one, which started on Jan. 1, 2015 and will be in effect until December 2022, requires the exchange of “chain-of-ownership data.”
  • Unique Serialization: Beginning in November 2017 until 2019, the second phase will require that “pharmaceutical products be marked with anational drug code, serial number, lot number, and expiration date in machine-readable and human-readable form.”
  • Serialized Item-Level Traceability: From 2023, information must be provided to allow supply chain partners to trace the transaction historyback to the initial manufacturer or re-packager.

Are you ready to comply with all of the requirements by February 2019?

MIAS Pharma Ltd's team of consultants, which includes a number of former EU regulators, provides oversight of our clients' entire supply chains to ensure compliance with the requirements of the FMD.

For further information on how MIAS Pharma Limited can assist your organisation, contact us at +353 1 846 3604/ 5 or info@miaspharma.com.