Understanding the National System for Controlled Product Management (SNGPC)
The National Health Surveillance Agency (Anvisa) has announced that the National System for Controlled Product Management (SNGPC) is fully operational, with mandatory compliance expected from establishments starting in early 2025. This system is crucial for monitoring the movement of controlled substances within pharmacies and ensuring regulatory compliance. As the final testing phase concluded on December 31, 2024, Anvisa emphasizes the importance of pharmacies utilizing this tool to prepare for its mandatory implementation.
The SNGPC serves as a centralized database that tracks the distribution and sale of controlled medications in Brazil. It is designed to enhance the transparency and accountability of pharmaceutical practices, which is vital for public health and safety.
Pharmacies are encouraged to engage with the SNGPC to identify potential areas for improvement and necessary adjustments before the system becomes mandatory. This proactive approach will help ensure that the system operates robustly and stably once it is fully in effect. Importantly, pharmacies should note that they are not required to send information to the SNGPC at the time of medication sales. This allows them to gradually adapt to the system’s requirements without immediate pressure.
Key points to consider regarding the SNGPC:
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Voluntary Participation: Pharmacies are currently encouraged to use the SNGPC voluntarily. This is an opportunity to familiarize themselves with the system without the immediate consequences of regulatory oversight.
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System Updates: Pharmacies should take this time to update their records and adjust internal systems to align with SNGPC requirements. This includes reviewing operational routines and ensuring all necessary documentation is in order.
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Documentation Compliance: Throughout the operation of the SNGPC, pharmacies must maintain accurate internal records to verify stock and comply with audits. This is in accordance with the regulations set forth in Resolutions RDC 586/2022 and the documentation retention guidelines from Portaria SVS/MS 344/1998 and RDC 22/2014.
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Training Resources: Anvisa has made available a series of four instructional videos that provide detailed explanations about the SNGPC, covering topics from its purpose to user queries. These resources are essential for pharmacies to understand and implement the system effectively.
In October, Anvisa released a timeline for the final phase of updates and invited private pharmacies across Brazil to participate. During this operational period and beyond, maintaining accurate records will be critical for compliance and oversight.
In conclusion, the SNGPC is an essential system for managing controlled products in Brazil. Pharmacies should take advantage of the current voluntary phase to familiarize themselves with the system, update their records, and prepare for the mandatory implementation in 2025. By doing so, they can ensure a smooth transition and contribute to the overall safety and regulation of controlled substances in the healthcare system.
