Morocco

Regulation name

Draft national pharmaceutical traceability regulation (under development, not yet enacted)

Serialization status

In progress – draft regulations exist, pilot discussions underway; no mandatory serialization enforced yet

Country population

~38 million

Alert requirement: Not available – to be determined in final regulation

Aggregation requirement: Not yet defined — may be introduced in later phases

Track & Trace requirement: Planned — envisioned in draft traceability framework

Official governing body: Likely Directorate of Medicines & Pharmacy under Ministry of Health (not yet officially designated)

Implementation deadline / enforcement date: Not set — to be decided when draft becomes regulation

Serialization type / level: Undetermined — expected to include secondary unit level in initial rollout

MAH / CMO responsibilities: Not yet specified

Serialized product scope: Not determined — widely anticipated to cover Rx initially

Penalties for non-compliance: Not defined — to be established in enacted regulation

Repackaging rules: Not specified — expected to follow GS1 GMP once drafted

Serialization exemption rules: None known — any exemptions not yet outlined

Market coding requirements:

Not defined — expected to follow GS1 DataMatrix standards once regulation is enacted

Spanish