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The Pharmaceutical industry is gradually coming into compliance with new regulatory requirements including the Falsified Medicines Directive (FMD) for Britain and the Drug Supply Chain Security Act (DSCSA) for the US. An important deadline coming up in November 2017 mandates that manufacturers must include product identifiers, serial numbers, lot numbers, and expiration dates in their labels.
The FMD is a European Union (EU) directive to harmonize new public health rules with existing EU directives. The FMD ensures medicines are safe for consumers and that trade is controlled. Each pharmacy dispensing medicine must have an EU-wide logo present on online stores’ websites verifying their legal status.
Packaging News addresses the elephant in the room: what is Brexit’s effect on this? What about the DSCSA and President Trump?
Independent of FMD regulations, UK manufacturers looking to increase trade with the US have to address the requirements of the DSCSA to remain globally competitive. Even in a worst case scenario, a “hard Brexit” as they say, the UK would lose single-market access but UK-originated medicines already on the market are not going to be very affected.
There is also the timing of Brexit, Brexit includes a 2-year negotiation period that would conclude in spring 2019, which is after the FMD deadline of February, 2019. Therefore, regardless of Brexit, UK manufacturers would already be in compliance with the FMD. This includes adding a secondary-level serialization to a GS1 standard serial number issued by the manufacturer. Other product identifiers could include a GTIN/country specific code or additional country-specific data in addition to the GS1 barcode label.
For those unfamiliar with the terminology, GS1 is the organization formerly known as the European Article Numbering-Uniform Code Council and it developed the Global Trade Item Number (GTIN). GTIN is a subset of GS1 data structures. It is a 14 digits long and usually comes in the form of a barcode. Companies can use radio frequency identification (RFID) labels. The Universal Product Code (UPC) that is employed by North American companies is a variation of GTIN known as GTIN-12.
Many industry insiders commented that the UK has more or less adopted the requirements of the FMD by way of a national medicines verification system (NMVS) that employs serialization and ensures falsified products do not enter the supply chain. Thus, complying with the FMD is not a leap for them.
The situation with DSCSA is different as there is no international unified system when it comes to serialization. Laws vary by country and can be inconsistent. Some nations do not require serialization for pharmaceuticals. Complying with multiple standards across different countries becomes expensive and cumbersome.
One commonality is tamperproof seals. Countries are on the same page when it comes to packaging requirements to prevent tampering and to make packaging child-proof. Some manufacturers use adhesives, and others use multi-level seals. As the standards and regulations become more complex, there has been an emergence of packaging and labeling-oriented technologies.
Then there is the Trump wildcard. The DSCSA was signed into US law by former President Barack Obama in 2013. President Trump is still assessing the DSCSA and has been rumored to eventually repeal it. US companies should plan to continue moving towards complying with DSCSA regulations, including having a track and trace system, Unique Device Indicator (UDI) serial numbers for products, and meeting validation requirements until the law is repealed or reworked.
For companies looking to comply with DSCSA, a solution in the form of Electronic Batch Records (EBR) exists as InstantGMP™ PRO. InstantGMP™ PRO is a sophisticated and robust software that encompasses a Manufacturing Execution System (MES) with EBR. It meets the traceability requirements and can handle serialization, but is also customization and integration friendly. Learn more about InstantGMP™ PRO by experiencing a live demonstration.