The Substitute Technical Health Regulation for the Operation of the National Pharmacovigilance System, published through Resolution ARCSA-DE-2025-052-DASP, entered into force today. The regulation governs the detection, notification, evaluation and prevention of risks related to the use of medicines.

Who does it apply to?

Compliance is mandatory nationwide for public and private entities of the National Pharmacovigilance System. It includes obligations for health registration holders, pharmaceutical establishments, health facilities and health professionals.

Its scope covers medicines, biological products for human use, processed natural products for medicinal use and homeopathic products, as well as products subject to the regulation that enter the country through exceptional importation, donation or homologation.

Deadline to implement MedDRA and WHODrug

Pharmaceutical establishments and health registration holders must implement, by August 4, 2027, the MedDRA terminology to code clinical manifestations, diseases and abnormal laboratory findings, and the WHODrug dictionary to code medicines and vaccines, in accordance with ARCSA guidelines. This specific deadline does not postpone the entry into force of the other provisions.

Recommendations:

• Identify the applicable obligations according to the activity of each establishment and verify the designation of those responsible for pharmacovigilance.
• Review and update internal procedures, records and the Pharmacovigilance System Master File, as well as agreements with third parties involved in these activities.
• Verify the mechanisms and deadlines for notifying adverse events to ARCSA, ensuring the traceability of information and the protection of personal data.
• Verify compliance with Good Pharmacovigilance Practices, including the preparation of periodic safety reports, risk management and the updating of product safety information, where applicable.
• Train the personnel involved in pharmacovigilance activities and strengthen internal detection and reporting mechanisms.
• Plan the implementation of MedDRA and WHODrug within the established deadline, identifying the necessary technological and operational adjustments.

This document does not constitute a legal opinion; it is merely a general informational bulletin. Should you require specific advice, please contact us at the following addresses: