Panama-Operating License and Sanitary Registration of Medicines

National Directorate of Pharmacy and Drugs – Ministry of Health, Panama

Published: September 17, 2026

Legal Framework

• Law 419 of February 1, 2024: Regulates medicines and other products for human health, as well as the public procurement of medicines, health supplies, medical devices, and medical equipment.
• Executive Decree 27 of May 10, 2024: Regulates Law 419 of 2024.

The Ministry of Health, through the National Directorate of Pharmacy and Drugs (DNFD), is empowered to verify compliance with the sanitary provisions applicable to establishments engaged in the importation, conditioning, manufacturing, and other activities related to medicines and products for human health (except for the sanitary registration process for export purposes).

It also establishes the rules and procedures governing the selection of bidders and the procurement of medicines, medical devices, and medical supplies by public entities (MINSA, CSS, public institutions, and any entity using public funds or national assets).

Objectives

• Promote the availability of medicines and products for human health use.
• Establish regulatory mechanisms to monitor compliance with the quality, safety, and efficacy of health products.

Key Definitions

• Distribution agency: Establishment engaged in the importation, exportation, re-exportation, storage, distribution, transportation, and wholesale commercialization of pharmaceutical raw materials, medicines, vitamin supplements with therapeutic properties, cosmetics, and household and hospital pesticides and disinfectants. Includes logistics centers.
• Free Sale Certificate: Document issued by the competent authority of the country of origin certifying that the medicine is registered and authorized for human consumption. Must be submitted in Spanish or translated, authenticated before a Panamanian consul (or a consul of a friendly country) or with an apostille.
• Generic medicine: Medicine distributed or dispensed labeled with the generic name of the active ingredient (arts. 49, 51, 69; E.D. 27-29).
• Sanitary Registration: Authorization issued by the health authority for the importation and/or commercialization of a pharmaceutical product, following the corresponding evaluation procedure (art. 4).
• Abbreviated Sanitary Registration: Applicable to new registrations, renewals, and modifications of medicines with certifications issued by accredited international organizations or high-standard regulatory authorities.
• Accountability: The DNFD will publish on the Ministry's portal all resolutions, sanitary registration certificates, interchangeability certificates, special importation permits, operating licenses of pharmaceutical establishments, and registrations of non-pharmaceutical establishments.

Sanitary Registration

Application Requirements

The application must be submitted through an attorney, endorsed by the qualified pharmacist responsible for the technical procedure and by the National College of Pharmacists:

1. Power of attorney evidencing legal representation.
2. Pharmaceutical Product Certificate WHO-type (original or authenticated photocopy of the legalized document). Alternatively: free sale certificate + Good Manufacturing Practices (GMP) certificate for each manufacturing establishment.
3. Manufacturing contract (or extract of the relevant parts), when applicable.
4. Complete quantitative and qualitative formula per dosage unit.
5. Product monograph.
6. Analytical methods validated in accordance with the RTCA Pharmaceutical Products.
7. Organoleptic, physical, chemical, biological, and microbiological specifications of the finished product.
8. Labels for primary and secondary packaging and insert, in accordance with the RTCA on Labeling.
9. Stability Study Report (RTCA).
10. Safety and efficacy studies.
11. Analytical standards.
12. Samples of the finished product (in harmonized quantity).
13. One unit of the finished product.
14. Proof of payment of the applicable fee.

Administrative Filing Rules

• The application, filed by the attorney, must be endorsed by the qualified pharmacist and the National College of Pharmacists.
• Power of attorney duly notarized by the holder, manufacturer, or legal representative of the applicant company.

Certification Procedure

• The DNFD will issue the sanitary registration within a maximum of 20 business days, once the satisfactory analysis is received from the reference laboratory.
• Reference laboratories have up to 60 days to issue the analysis result.

Priority for Innovative Medicines

The DNFD may grant priority to applications for innovative medicines, subject to a special priority fee, when there is a health need for the Panamanian population.

Validity and Renewal

• Validity: 5 years, renewable at the end of each period.
• The renewal application must be filed at least 3 months before expiration.
• During the renewal period, the product may be freely imported and marketed.
• If the registration expires without a timely renewal application, it loses its validity and registration number.

Sanitary Registration under Abbreviated Procedure

• No prior laboratory analysis is required if the product is registered and marketed in countries with high-standard regulatory authorities pre-qualified by WHO/PAHO and recognized through executive decree.
• The holder must arrange the post-registration quality analysis of the first imported batch within 6 months, in an authorized reference laboratory, and submit evidence to the DNFD.
• If results are unsatisfactory or evidence is not provided within the deadline, the DNFD will suspend the use of the medicine and order its withdrawal through a reasoned resolution.

Importation under a Sanitary Registration

A sanitary registration may be used for importation and commercialization by a third party different from the holder, provided that:

• The product is identical in name, formula, pharmaceutical form, dosage, and composition (same excipients).
• It comes from the same laboratory or manufacturing company.
• It has been legitimately manufactured by the trademark/patent holder or by an authorized party.
• It complies with all approved specifications.

The health authority will issue an Importation Certificate under Current Sanitary Registration.

Operating License

Mandatory Requirement

The manufacturing, distribution, conditioning, storage, transportation, commercialization, and dispensing of pharmaceutical products may only be carried out in pharmaceutical establishments that hold a valid operating license issued by the DNFD, under the responsibility of a pharmacist regent.

The DNFD is competent to issue operating licenses for both pharmaceutical and non-pharmaceutical establishments.

First-Time Requirements

1. Notarized power of attorney.
2. Form completed according to the type of pharmaceutical establishment.
3. Original Public Registry Certificate.
4. Photocopy of ID or passport of the legal representative/owner and of the pharmacist regent.
5. Design of the internal areas of the facility, indicating size in square meters.
6. Payment of the service fee according to the type of establishment.

Platform Process

1. Upload the requirements at faddi-minsa.panamadigital.gob.pa.
2. Evaluation: assignments are made on Mondays.
3. Pharmaceutical inspection (approximately 15 days after requirements review).
4. Review of the inspection report.
5. Issuance of the license.

Inspection Payment

• Access the payment gateway.
• Select "Pharmacy" and in the description enter "Inspection".
• Documents must be uploaded as a single combined PDF file.

General Notes

• Payments equal to or greater than US$200 must be made by certified check payable to the National Treasury.
• For controlled substances, there is a dedicated section in the sanitary registration procedure.
• Consult the possibility of applying to the abbreviated procedure based on the product's origin and certifications.

Key references:

Law 419 2024, Panama

Executive Decree  24 2024

Dr. Kathia Lee Duque, Law 419 2024

Need attorney support? Contact us!  +507 62601471 info@re-legal.com.pa