Summary of Executive Decree No. 2 of January 7, 2025
Executive Decree No. 2 of January 7, 2025, issued by the Ministry of Health of Panama, establishes a procedure for the automatic recognition of sanitary registrations for medicines manufactured and registered in countries whose regulatory authorities are part of the list of authorities recognized by the World Health Organization (WLA).
The regulation simplifies the sanitary registration process for medicines approved by authorities with high regulatory standards, eliminating the need for prior laboratory analysis, provided that the established conditions are met.
Requirements to Apply for the Automatic Recognition Procedure (Article 2)
- Proof of payment for the fee corresponding to the issuance of the sanitary registration through the expedited process.
- Completed form as established by the National Directorate of Pharmacy and Drugs, submitted through the digital platform FADDI, with the endorsement of the responsible pharmacist and the National College of Pharmacists.
- Legalized power of attorney accrediting the legal or technical representation of the holder of the pharmaceutical product by a natural or legal person residing in Panama.
- Original Pharmaceutical Product Certificate, legalized or apostilled, issued by the country of origin. If multiple laboratories are involved, information on compliance with Good Manufacturing Practices must be included.
- Legalized or apostilled copy of the complete dossiersubmitted in the country of origin to ensure post-recognition health surveillance.
- Stability studies for medicines requiring it, according to the climatic zone IVb applicable to Panama.
- Consistency of information between the country of origin of the medicine and the certificate submitted via the FADDI platform.
The process, conducted exclusively through the FADDI platform, must be completed within a maximum of ten business days, unless technical observations are identified. In case corrections are needed, the applicant has an additional five business days to address the inconsistencies. Otherwise, the request will be canceled.
This decree aims to streamline access to safe and effective medicines for the Panamanian population, while maintaining high-quality standards through post-recognition health surveillance.
The regulation came into effect on the date of its promulgation and is based on existing legal provisions, such as Law 419 of 2024 and Law 109 of 2019.
For more information, contact us to assess the impact of this regulation on your business activities and market strategies: info@central-law.com
Yolianna Arosemena Benedetti
Partner
Panama
