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Panama Introduces Automatic Recognition for Health Registrations
In January 2025, Panama passed Executive Decree No. 2, establishing an innovative procedure for the automatic recognition of health registrations for medicines. This new framework aims to streamline the registration process for medicines manufactured and registered in countries with regulatory authorities recognized by the World Health Organization (WHO).
What does the decree establish?
The decree allows medicines already registered and marketed in countries with WHO-recognized regulatory authorities to obtain their health registration in Panama without prior laboratory analysis. This procedure seeks to ensure the quality, safety, and availability of medicines efficiently.
Requirements for Automatic Recognition
To apply for automatic recognition, applicants must meet the following requirements:
- Payment of fees for the expedited process.
- Submission of a digital form via the FADDI platform.
- Legalized powers of attorney accrediting the applicant’s representation.
- A Certificate of Pharmaceutical Product issued by the country of origin, legalized or apostilled.
- A complete copy of the registration dossier submitted in the country of origin.
- Stability studies for medicines requiring compliance with Panama’s climate zone IVb.
Timelines and Follow-Up
Once the complete application is submitted, the National Directorate of Pharmacy and Drugs will issue a response within ten business days. If technical observations are identified, the applicant will have five business days to address them. Failure to comply will result in the cancellation of the application, requiring the process to start over.
Control and Oversight
The decree also grants health authorities the ability to inspect establishments importing, distributing, or selling medicines registered under this procedure, ensuring compliance with current regulations.
With this decree, Panama is taking a significant step toward modernizing and simplifying regulatory processes, ensuring the availability of high-quality medicines for its population.
For more information, contact us at bd@icazalaw.com.
