Pharmaceutical serialization

Pharmaceutical serialisation is the tracking and tracing of the passage of prescription drugs through the supply chain from manufacturing to dispensing. This is generally accomplished through automated, electronic means, and is legally required in many countries. It involves such company practices as recording, authenticating, maintaining and sharing accurate records of items prior to dispatching. Pharmaceutical serialisation uses track and trace technology though the timings for implementation and the information required for a serialisation program is dependent on local national laws and standards.

Argentina

In 2011, Argentina introduced a catalogue of drugs covered but its national drug traceability scheme, listing more than 3,000 drugs that require the placing of unique serial numbers and tamper-evident features on the secondary packaging. The drugs listed are recorded in real time in a central database managed by the National Administration of Drugs, Foods, Medical Devices of Argentina (ANMAT), Regulation 3683, which uses Global Location Numbers (GLNs) to identify the various actors in the supply chain. The purpose of this program is to actively limit the use of illegal drugs.

Brazil

The 2009 Brazilian Federal Law 11.903 and subsequent regulations of the National Agency for Sanitary Surveillance in Brazil (ANVISA) require that a 2D data matrix code be put on all secondary packaging. Under these provisions, manufacturers will be required to maintain a database of all transactions from manufacturing to dispensing, while distributors must report serialized transaction data to the manufacturer and keep a database of suppliers, medicine recipients, and packing companies.

China

In 2008, China’s State Food and Drug Administration (CFDA) made serialization mandatory for over 275 therapeutic classes of individual saleable product units by December 2015. The CDFA does not follow an international standard. Manufacturers may only register their products and obtain their serial numbers by applying to the China Product Identification, Authentication and Tracking System (PIATS). They must also implement a quality control system with an electronic drug-monitoring system, a standardized documentation system, and bar codes to ensure pharmaceutical traceability. Companies importing drugs into China must designate a local pharmaceutical company or wholesaler as their electronic monitoring agent in the country. In addition to legislative reforms, China has increased enforcement efforts at the provincial and local levels. In 2013, the Chinese government coordinated joint special enforcement campaigns targeting counterfeit drugs.