January 3, 2014

In a release by the Ministry of Trade and Ministry of Health of Libya, draft regulations were released regarding serialization for all pharmaceutical products imported into Libya. Currently, there is a law that requires GTIN, lot, and expiry to be printed on the drug package in human readable form. The draft regulation would require the addition of a serial number in human readable and all data elements to be encoded in the data matrix. The example below would satisfy the proposed regulation:

(01)03453120000011(17)120508(10)ABCD1234(21)987654321012

No timeline for implementation has been established in the draft regulation. The new law may require a manufacturers to provide the Libyan government with the GTIN, expiry date, lot, and serial number to be stored in a central database.

Excellis Health Solutions Recommendations and Comments It is unclear whether the regulation will follow a track and trace system or authentication model. Draft regulation does not mention if serial numbers should be generated randomly or

sequentially. Aggregation would be required if a track and trace system is adopted. Draft does not specify data carrier for packaging levels about the saleable unit.

See embedded document for sourcing legislation:

Proprietary and Confidential1

Serialization Regulation Advisory

Libya