Learn about the legal, health, and administrative requirements you must meet to import, distribute, and market medicines in Panama.
Panama is a strategic location for commercial and logistics activities in the region. Its international connectivity, port infrastructure, and foreign trade facilities offer opportunities for companies interested in importing, distributing, and marketing pharmaceutical products.
However, entering this sector requires much more than incorporating a company and obtaining a Notice of Operation. The marketing of medicines is subject to specific health regulations that establish requirements for establishments, technical personnel, and the products intended for commercialization.
If you are considering establishing a pharmaceutical company in Panama, whether in Panama City, Colón, or in connection with international trade operations, it is important to understand the authorizations required under Panamanian law before beginning operations.
1. Incorporate a company and properly define its business activities
The first step is to establish the legal structure of the company that will conduct the business activities.
In Panama, investors may choose from different legal structures, including a corporation (S.A.) or a limited liability company (S. de R.L.), depending on their business objectives, shareholder structure, and operational needs.
At this stage, it is important to clearly define the company’s corporate purpose, including the activities it intends to carry out, such as:
Importation of medicines and pharmaceutical products.
Wholesale distribution and commercialization.
Retail sales.
Storage of pharmaceutical products.
Exportation and re-exportation, when applicable.
The activities to be carried out must be consistent with the commercial and health authorizations subsequently obtained.
2. Obtain the Notice of Operation
Once the company has been incorporated, the Notice of Operation must be processed through the Panama Emprende system, administered by the Ministry of Commerce and Industries (MICI).
This document identifies the commercial activities the company will carry out and constitutes one of the administrative requirements for obtaining the corresponding authorizations from the health authorities.
It is important to understand that the Notice of Operation does not replace the health license required to conduct activities involving medicines.
Therefore, having a company registered with the Public Registry and an active Notice of Operation does not automatically authorize the company to import, store, distribute, or sell pharmaceutical products.
3. Obtain the operating license from the Ministry of Health
This is one of the most important requirements for entering the pharmaceutical sector.
The National Directorate of Pharmacy and Drugs (DNFD), a division of the Ministry of Health (MINSA), is responsible for regulating and supervising establishments that conduct activities involving medicines and other products intended for human health.
Under Law 419 of February 1, 2024, and its implementing regulations established by Executive Decree No. 27 of May 10, 2024, establishments that manufacture, package, import, store, distribute, or market regulated products must obtain the operating license or registration applicable to their activities.
The following categories of establishments must be distinguished:
Drug wholesalers: establishments authorized to import and sell pharmaceutical products at the wholesale level, among other permitted activities.
Distribution agencies: establishments engaged in the distribution of pharmaceutical products, according to the scope of their license.
Pharmacies: establishments dedicated to dispensing and selling medicines at the retail level, subject to specific operating requirements and pharmaceutical care standards.
Non-pharmaceutical establishments: businesses that may sell certain over-the-counter medicines at the retail level, provided they have obtained the corresponding registration from the health authority.
This classification is not merely a formality. It determines which activities the company may carry out and the requirements it must meet to operate legally.
4. Appoint a duly qualified pharmacist as technical director
Operating a pharmaceutical establishment requires the involvement of a duly qualified pharmacist who assumes the corresponding technical responsibility.
This professional, known in Panama as a regente farmacéutico (pharmacist-in-charge), is responsible for matters related to compliance with health regulations, proper product handling, storage conditions, and supervision of the establishment’s technical operations.
Their involvement is essential to ensuring that medicines maintain their quality, safety, and efficacy throughout the different stages of the commercialization process.
The company must plan for this appointment from the outset, as it is not a requirement that can be postponed until after operations begin.
5. Comply with storage requirements and health inspections
Facilities where medicines are stored, distributed, or sold must comply with the health and technical conditions established by the competent authority.
Depending on the activity and the type of products handled, requirements may include:
Temperature and humidity conditions.
Storage and preservation systems.
Inventory control and traceability.
Handling of expired or damaged products.
Transportation and distribution procedures.
Hygiene and safety conditions within the facilities.
The National Directorate of Pharmacy and Drugs may conduct inspections to verify that establishments comply with the applicable regulations.
Consequently, before leasing or preparing commercial premises or a warehouse, it is advisable to verify that their characteristics are compatible with the pharmaceutical activities the company intends to conduct.
6. Obtain sanitary registration for medicines
Authorization to operate as a pharmaceutical company does not mean that all medicines may be freely marketed.
Each product must comply with the health requirements established under Panamanian law.
For imported medicines, sanitary registration is a fundamental authorization for their importation and commercialization within Panama.
Documentation that may be required to obtain sanitary registration includes:
Qualitative and quantitative composition of the product.
Certificate of Free Sale issued by the health authority in the country of origin.
Good Manufacturing Practices (GMP) certificate.
Product Certificate of Analysis.
Manufacturer’s analytical method.
Corresponding labels and packaging.
Stability studies, when required.
Medicinal product monograph.
Product samples.
Corresponding professional endorsements.
The specific documentation required will depend on the characteristics of the medicine and the regulations applicable to its registration.
It is also important to note that the company must comply with the corresponding importation and quality control procedures before the products can be marketed.
7. Consider special regulations for controlled medicines
If the company intends to market medicines containing substances subject to special controls, such as certain narcotics and psychotropic substances, it must comply with additional regulations.
In Panama, these products are subject to specific controls concerning their importation, storage, distribution, dispensing, and documentation.
Therefore, holding a standard operating license is not sufficient. It is necessary to verify the specific authorizations and conditions applicable to each substance and activity.
What happens if you want to establish your pharmaceutical company in Colón?
The province of Colón is an attractive location for companies involved in international trade, particularly because of its logistics infrastructure and connections to regional and international markets.
The possibility of conducting commercial activities from this province may appeal to investors interested in importing, distributing, storing, and re-exporting pharmaceutical products.
However, it is important to distinguish between commercial and customs benefits and health regulatory requirements.
For example, operating from the Colón Free Trade Zone does not eliminate the obligation to comply with Ministry of Health regulations when the activity involves medicines and other regulated products.
The company’s location, business model, and the destination of its products must be analyzed together to determine the necessary authorizations.
For this reason, before investing in infrastructure, inventory, or logistics, it is advisable to assess the legal and health regulatory feasibility of the project.
Getting started correctly is essential for smooth operations
Establishing a company dedicated to marketing pharmaceutical products in Panama represents a business opportunity, but it also entails significant regulatory compliance responsibilities.
Company incorporation, the Notice of Operation, the license issued by the National Directorate of Pharmacy and Drugs, the appointment of a pharmacist-in-charge, and sanitary registration of the products are some of the elements that must be considered during the initial planning stage.
The key is to identify from the beginning which activities the company will carry out, what types of products it will handle, and which authorizations it needs to operate.
At Coronell, Lam & Asociados, we can guide you through the legal structuring of your company and help you identify the requirements necessary to conduct commercial activities in Panama.
If you are considering establishing a pharmaceutical company in Colón or any other province in the country, our team can assist you with the legal planning and organization of your project.
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