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Mandatory Quarterly Medicinal Cannabis Reporting to Enhance Market Supervision

Clinical Practice
Mandatory Quarterly Medicinal Cannabis Reporting to Enhance Market Supervision

Portugal’s National Authority for Medicines and Health Products (INFARMED) has approved a uniform quarterly template that captures all cultivation, manufacturing, and research activities involving cannabis for medicinal, veterinary, or scientific purposes. Entities must submit these reports electronically within 15 days of each quarter’s end, as outlined in the official deliberation.

The regulation demands complete visibility across the entire production chain, from raw materials through intermediates, finished products, residues, and surpluses. Every figure must match the operator’s internal records of entries, exits, transformations, and inventories, with any discrepancies clearly explained.

Deadline Discipline Enforced

Authorised operators face a strict 15-day post-quarter deadline for electronic submission using the exact templates published in Annexes I and II. Batch numbers, dates, and units of measure must be included wherever applicable to guarantee data integrity and audit readiness.

The measure draws its authority directly from Law n.º 33/2018 and longstanding provisions in Decree-Law n.º 15/93 and Decree-Regulatory n.º 61/94, which already require operators to maintain updated traceability records from seed to final destination. By standardising formats, INFARMED transforms these obligations into consistent, comparable datasets that strengthen supervisory capacity.

Data Systems Set to Transform Oversight

Robust medicinal cannabis reporting will deliver reliable, real-time intelligence to regulators, supporting tighter control of the licit market and more informed decisions on supply integrity. Long-term record preservation and inspection-ready archives further embed transparency across the value chain.

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