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Anvisa

Notice to pharmacy professionals: the mandatory use of SNGPC will return in 2025.

Pharmacies’ participation is essential to detecting possible areas for improvement and making adjustments before the system becomes mandatory again.

Anvisa reinforces the importance of SNGPC and guides pharmacies towards a mandatory return in 2025

The Brazilian Health Surveillance Agency (Anvisa) informs that the Brazilian System for Management of Controlled Products (SNGPC) is in full operation and highlights that pharmacies must prepare for the system’s mandatory return to use, scheduled for the beginning of 2025.

Even with the end of the last testing phase, which concluded on December 31, 2024, the system continues to be active and available for use. Anvisa recommends that pharmacies take advantage of this period to familiarize themselves with the tool, clarify doubts through the Contact Us service channel (available at www.gov.br/anvisa), and consult the explanatory material accessible on the agency’s official website (link here).

The voluntary adherence of pharmacies to the system, from now on, is essential to identify possible points for improvement and make necessary adjustments before the use of SNGPC becomes mandatory again. Preparation helps ensure that the system functions robustly and stably at the time of mandatory return.

Submission of Information and Adjustment Period

Anvisa clarifies that, during this phase of voluntary use, sending information to SNGPC does not need to be done immediately after the medicine is sold. Furthermore, any data transmitted or recorded during this period will not be used as a basis for inspections by the competent bodies.

This is the ideal time for pharmacies to update their registrations, adjust their internal systems, and adapt their operational routines. These preventive actions will help minimize errors and optimize processes when the system becomes mandatory again.

Background and Recommendations

In October 2024, Anvisa released the schedule for the last stage of registration updating, encouraging the participation of private pharmacies across Brazil. During this period of adaptation and after the mandatory return of the system, it is essential that pharmacies maintain internal records of movements. These records are essential for proving stocks and meeting the tax requirements established by Collegiate Board Resolution (RDC) 586/2022. The deadline for document retention, defined by SVS/MS Ordinance 344/1998 and RDC 22/2014, remains unchanged.

Available Training

To support users of the system, Anvisa has made available a series of explanatory videos about SNGPC. The material covers the following topics:

  1. What is SNGPC?
  2. Registration and accreditation in the system.
  3. SNGPC’s main functions.
  4. FAQs and answers.

These videos are a valuable tool to understand how the system works and prepare for mandatory use. More information and guidance for testing is available on Anvisa’s official website.

This period of voluntary use of SNGPC represents a unique opportunity for pharmacies to adjust to the new requirements, improve their internal practices, and ensure a smooth transition when the system becomes mandatory again in 2025. Take advantage of available resources, clarify doubts, and be prepared to comply with regulations with excellence.

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