Serialization Requirements in Pakistan
To ensure a safe and efficient pharmaceutical supply chain, the Drug Regulatory Authority of Pakistan (DRAP) is planning to implement serialization and track&trace measures. As per a notification published in June 2017, all drugs will have to be uniquely identified and serialized in the future, no matter whether they are destined for the domestic market or export.
Serialization and UPID requirements in Pakistan
To ensure unique product identification (UPID), Pakistan has chosen to use GS1 standards. A machine-readable 2D datamatrix will be used for the primary and secondary packaging levels, a one-dimensional ID barcode and SSCC (Serial Shipping Container Code) on the tertiary packaging level. The datamatrix will have to include information such as Global Trade Item Number (GTIN 14), expiry data in YYMMDD format, batch number, alphanumeric product identification information and an alphanumeric up to 20 digits long serial number.
Product information incl. serial numbers will have to be reported to DRAP’s online database.
Deadlines: step by step to track&trace
The law will come into force in December 2017 (6 months after publication in the Gazette of Pakistan) leaving manufacturers and importers 2 years to comply with Pakistani serialization requirements. Serialization on primary and secondary level are thus optional for the time being but will become mandatory from December 2019. By December 15 2020, complete track& trace of each unit of sale and shipment will be compulsory.
Scope of the law
Concerned by the legislation are allopathic drugs for human and veterinary use under the exclusion of “alternate [sic, as published in The Gazette of Pakistan June 2017] medicines, health and OTC non-drug products, nutraceuticals”, medical gases and radio-pharmaceuticals. The law applies to domestically produced drugs as well as to imported drugs. Should imported drugs not be compliant with the DRAP’s requirements, the importer can make arrangements with a local facility that is licensed to produce and sell medicines if the Registration Board approves.