Pharmacovigilance
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Pharmacovigilance Representative
Each month, our team engages directly with the Pharmacovigilance Department at the National Directorate of Pharmacy and Drugs to ensure full regulatory alignment.
We submit detailed periodic safety reports and actively consult on updates or feedback related to every product we represent. This hands-on, proactive approach allows us to stay ahead of potential issues, ensure ongoing compliance, and give our clients peace of mind.
With Pharmacy Solutions managing your pharmacovigilance, you gain a reliable partner dedicated to protecting your product and reputation in the market.




Pharmacovigilance Frequently Asked Questions
Pharmacovigilance in Panama encompasses the activities dedicated to identifying, evaluating, understanding, and preventing adverse effects or any other drug-related issues that may arise after a medical drug has received its Sanitary Registration and is being used in the Panamanian population. It is essential for continuously monitoring the safety profile of authorized medicines.
Adherence to Panama's Pharmacovigilance regulations is a fundamental requirement for maintaining the validity of a medical drug's Sanitary Registration. Non-compliance with these regulations, including failure to adequately monitor and report adverse events, can result in sanctions, potentially leading to the suspension or cancellation of the registration by the Ministry of Health (Ministerio de Salud).
Marketing Authorization Holders (MAHs) in Panama, who are the holders of the Sanitary Registration, are legally obligated to establish and maintain a functional Pharmacovigilance system. This includes the timely reporting of suspected adverse drug reactions (ADRs) and the submission of Periodic Safety Update Reports (PSURs) to the Panamanian health authorities according to the established procedures and timelines.
Information gathered through Pharmacovigilance activities can necessitate updates to the product information (e.g., Summary of Product Characteristics, Package Insert) associated with the Sanitary Registration in Panama. If new safety concerns are identified, the MAH may be required to implement risk mitigation strategies or modify the registered indications, dosage, or contraindications in collaboration with the Ministry of Health.