Panama: Importing Medicines Without Registration, Article 358

What Article 358 of Executive Decree 27 of 2024 says

Executive Decree 27 of May 10, 2024, published in Gaceta Oficial Digital 30028-C, regulates Law 419 of 2024 on medicines and other products for human health in Panama¹. Its Article 358 begins: "Se autorizará la importación de los productos sin haber obtenido el registro sanitario cuando se trate de:" (imports of products without sanitary registration will be authorized when they involve:) and lists three cases: samples with no commercial value for a registration filing, cosmetics for personal use, and medicines for personal use imported through courier service or travelers¹.

Medicines for personal use: what is required

Item 3 of Article 358 refers to "medicamentos para uso personal importados a través de servicio de courier o viajeros" (medicines for personal use imported through courier service or travelers). It sets these conditions¹:

• For parenteral medicines, biologicals and blood derivatives, "la conservación de la cadena de frío es responsabilidad del importador" (keeping the cold chain is the importer's responsibility).
• The importer must present the prescription from the qualified professional.
• The importer must present a detailed invoice, a copy of the ID or passport, a liability-release letter to the health authority and the air waybill.
• The quantity to import may not exceed six months of treatment.
• A traveler must also present the retention record.

The text closes with an explicit ban: "No se permite la importación de materia prima o productos no terminados a través de servicio de courier o viajeros" (importing raw material or unfinished products through courier service or travelers is not allowed)¹. La Estrella de Panamá summarized these rules on October 18, 2024, when Minsa clarified that it "no ha implementado ningún requisito o procedimiento adicional a los consignados en el artículo 358" (has not implemented any requirement or procedure beyond those in Article 358)². La Prensa reported that from October 14, 2024 the documents had to be submitted in person at the DNFD import department window⁴.

What the article does not cover

Mulino was explicit on the same point: "lo que no podemos es permitir que se dedique una persona a hacer un negocio comercial de esto sin pagar impuestos" (what we cannot allow is a person making a commercial business of this without paying taxes)³. As a result, the exception in item 3 is for personal use; it is not a route to supply third parties or to resell. It does not cover raw material or unfinished product either¹.

A common mix-up: the caps of "up to six units per person" and "500 ml per month" that circulated in October 2024³⁴ appear in item 2 of Article 358, which deals with cosmetics; for medicines the limit is six months of treatment¹. If the product is not a finished medicine with a prescription in a person's name, item 3 does not describe its situation. Nothing in the text we reviewed turns a "research use" label into a personal-use permit.

"Research" is not a shortcut: it is a different pathway

Law 419 provides for import without registration "para fines de investigación científica, siempre que se cumpla con los parámetros de bioética y bioseguridad" (for scientific research, provided bioethics and biosafety parameters are met) and with prior approval from the authority in charge of health research (Article 45)⁶. Executive Decree 27 regulates it in Articles 372 to 374: an Authorization issued by the DNFD is required, and for clinical research that authorization is enough except for vaccines, blood derivatives and biotechnological products¹.

The DNFD publishes the requirements for research medicines under the exception⁵:

• Form F-01-ERS-DNFD, one for each medicine or placebo.
• A copy of the certificates of analysis of the lots.
• A letter to the National Director of Pharmacy and Drugs stating quantity, manufacturer, description and an expiration date not less than three months out.
• Approval and protocol from an accredited research bioethics committee, in Spanish and in electronic format.
• Proof of protocol registration with the health research regulation unit of the General Directorate of Public Health.
• The laboratory's Good Manufacturing Practice certificate and, if the applicant is not the principal investigator, the investigator's authorization.

In other words, the research exception depends on an ethics-approved protocol and a responsible institution, not on the importer's own declaration. On the clinical-trial framework in the country, see Law 84 and clinical trial registration in Panama.

Cold chain and quality: why the text leaves it to the importer

The decree places responsibility for the cold chain on the importer for parenterals, biologicals and blood derivatives¹. The practical reason shows in the literature: a 20-year review in the American Journal of Health-System Pharmacy found that, of 705 products approved by the FDA since January 2000, 246 required storage below room temperature, and acceptable excursion information existed for only 214 (87%)¹³. Another review in Cureus (2025) examines the stability of refrigerated medications at room temperature and the implications for transport¹⁴.

The deeper problem is the falsified or substandard product. The World Health Organization (WHO) defines falsified products as those that "deliberately misrepresent their identity, composition or source" and estimated in 2017 that 1 in 10 medicines in low- and middle-income countries failed quality control tests⁸. A meta-analysis in JAMA Network Open addressed the prevalence and economic burden of that problem⁹. For online purchases, a study in the Journal of Medical Internet Research (2024) bought semaglutide from six illegal pharmacies: three vials arrived, none of the three Ozempic pens did, semaglutide content exceeded the label by 28.56% to 38.69%, measured purity was 7.7%-14.37% versus 99% advertised, and endotoxin was detected in every sample¹⁰. The WHO issued an alert on counterfeit Ozempic in the global supply chain¹¹, and a case report in the European Journal of Hospital Pharmacy described a hypoglycemic coma from a falsified vial that contained insulin¹².

Enforcement in 2026

In September 2026, Minsa launched a national campaign in Panama against falsified medicines, led by the DNFD, with an alliance that includes the National Customs Authority, the Public Prosecutor's Office, the Ministry of Public Security and the University of Panama. According to Panamá América, the institution seized 25 tons of falsified products the previous year, and complaints filed through the official portal are processed in coordination with Customs and the Public Prosecutor's Office⁷. Under Article 368, the import invoice must also include the manufacturer's name, the conditioner's name, country of origin, route of administration, concentration and a signature¹.

For the physician, the map boils down to two questions: who is the patient named on the prescription, and which document authorizes entry. More context in Prescribing, importing, administering: a physician's legal map in Panama, in the registration exception in public procurement and in how to verify a certificate of analysis. This piece is journalism and regulatory analysis; it does not recommend any clinical use and is not legal advice.