Panama Simplifies Sanitary Registration Of Medicines: Executive Decree 2/2025

Published on Jan 28, 2025

Issa Rodríguez, Associate in Panama, expert on Regulatory Law, shares the following article on the executive Decree No. 2 of January 7, 2025, which establishes the procedure for the recognition of sanitary registrations to medicines manufactured and registered in countries with regulatory authorities that are part of the list of authorities of the World Health Organization. 

 

On January 13, 2025, Executive Decree No. 2 of January 7, 2025 ("Executive Decree 2/2025") was published in Official Gazette 30195-A, which establishes the simplified procedure for the recognition of sanitary registration of medicines manufactured and registered in countries with regulatory authorities that are part of the list of authorities of the World Health Organization (WHO). With this regulation, Panama seeks to accelerate the availability of quality medicines in the market, benefiting both consumers and the pharmaceutical industry. 

 

The main objective of Executive Decree 2/2025 is to reduce the times and costs associated with the process of sanitary registration of medicines, eliminating the need to carry out prior laboratory analysis, provided that the product has been registered and marketed in countries with regulatory authority that are part of the WHO list of authorities (WHO - WLA). This advance is significant, since it focuses on automatically recognizing the sanitary registrations granted by regulatory authorities in other countries, thus allowing faster access to medicines in our country. 

 

The new procedure is aligned with the principles of Law 109/2019 and Law 419/2024, which promote the accessibility and availability of essential medicines for the population. By relying on evaluations conducted by trusted authorities, Panama ensures that recognized medicines meet high international standards of quality, efficacy, and safety. 

 

The automatic recognition procedure includes the following key steps: 

 

SUBMISSION OF DOCUMENTATION: 

  • Proof of payment for the abbreviated procedure service. 

  • Form established by the National Directorate of Pharmacy and Drugs, submitted through the Digital Pharmacy and Drugs platform (FADDI), endorsed by a qualified pharmacist and the National College of Pharmacists. 

  • Legalized power of attorney that accredits the legal representation of the owner of the product. 

  • Original, legalized or apostilled Pharmaceutical Product Certificate. 

  • Complete record of the registration in the country of origin, also legalized or apostilled. 

  • Stability studies in climatic conditions IVb, as appropriate. 

 

VERIFICATION:  

The Panamanian authority, the National Directorate of Pharmacy and Drugs, will analyze the documentation submitted and verify the authenticity of the documents within ten (10) business days. Verification includes verification that the regulatory authority of origin is on the WLA list and that the product complies with applicable regulations.  

 

POSSIBLE OBSERVATIONS:  

If observations are found from the technical analysis, they will be notified through the Digital Pharmacy and Drugs (FADDI) platform, with a term of five (5) business days to correct the observations.  

 

APPROVAL: 

Once the observations have been corrected, the National Directorate of Pharmacy and Drugs will automatically issue the health registration number and the corresponding certificate within a maximum period of ten (10) business days. This procedure accelerates the introduction of new medicines to the market. 

 

INSPECTIONS: 

The National Directorate of Pharmacy and Drugs may carry out inspections of establishments that import, distribute and market medicines registered under this procedure. These inspections seek to ensure compliance with current health regulations and protect the health of consumers. 

 

The implementation of this Executive Decree 2/2025 not only positively impacts the pharmaceutical industry, but also the health system of Panama. By facilitating the entry of medicines into the market, greater competition is expected and, therefore, a reduction in product prices. This is particularly relevant in a global context where access to quality medicines at affordable prices remains a challenge. 

 

Executive Decree 2/2025 marks a milestone in Panama's health regulation, promoting efficiency and trust in drug registration processes. By implementing an automatic recognition system, Panama not only modernizes its regulations, but also positions itself as a leader in the region in terms of access to quality medicines. 

 

For pharmaceutical companies interested in taking advantage of this new scheme, our law firm in Panama is ready to assist you in the preparation and submission of your applications, ensuring compliance with all requirements and maximizing the opportunities offered by this innovative regulation. Initiatives such as Executive Decree 2/2025 are essential to build more resilient, equitable, and sustainable health systems. This decree not only benefits patients and businesses but also strengthens Panama's role as a model of regulatory efficiency in the region. 

 

 

The information provided by ARIAS® is presented for informational purposes only. This information is not legal advice and is not intended to create, and does not constitute, an attorney-client relationship. Readers should not act upon this information without seeking advice from professional advisers.