Recently, our legal system incorporated Law 419 of February 1, 2024, which regulates medicine and other products for human health and the public procurement of medicines. Other products for human health include health supplies, devices, medical equipment and cosmetic products. This new Panama Medicine Law, introduces significant changes in how medicines are regulated, distributed, and accessible for the Panamanian people.
Key points of this law include updated requirements for the approval of new drugs, incorporating safety and efficiency criteria, and the necessary steps to maintain an accurate and transparent drug registration.
Registration and approval of drugs
Executive Decree No. 27 of May 10, 2024, which regulates Law 419 of February 1, 2024, establishes a new drug registration and approval framework. This process is intended to ensure that all medicines available in the Panamanian market comply with international safety, efficiency and quality standards. Specific deadlines are introduced for reviewing and approving new registration applications, seeking to streamline people’s access to innovative and essential drugs.
Regulatory Body
In this regard, it is noticeable that Chapter V, Title II of the law grants power to the National Directorate of Pharmacy and Drugs to verify and monitor the quality and safety of pharmaceutical and related products and to authorize and issue licenses and certificates for their storage and distribution.
These regulations seek to protect consumers from misleading advertising or misinformation and ensure that all treatment decisions are based on reliable and truthful information.
Promotion and advertising
The new regulatory framework includes regulations on drug promotion and advertising. It requires that all claims about drugs be supported by scientific evidence and approved by the competent authority. Only medicines sold without a prescription are allowed to be promoted or advertised.
These regulations seek to protect consumers from misleading advertising or misinformation and ensure that all treatment decisions are based on reliable and truthful information.
Price control and access to medicines
Another highlight is the creation of the National Medicines Observatory. It will be responsible for publishing medicines’ reference prices to be used during the public procurement process. The objective is to establish fair prices and improve medicine accessibility for the general population, especially those medicines critical for severe and chronic diseases.
The National Drug Price Reference System (Sistema Nacional de precios de Medicamentos, Sinprem) was created. It will allow the revision of drugs purchase prices for public institutions and solidarity pharmacies, estimating a price reduction of 20% to 30%.
Public Procurement of Medicines
This new law also regulates public bids for medicines, supplies, devices and medical equipment. The tender process will be carried out through a call for bids following the requirements established in Law 22 of June 27, 2006, and those required by the electronic public procurement system PanamaCompra.
Law expert’s professional advice
Pharmaceutical developments increase the complexity of compliance with new laws and regulations. By relying on the advice of our law firm, you will have a team of specialized professionals who can represent you legally and ensure that your company’s operations fully comply with the requirements of this new law.
Whether you require the registration and approval of medicines, the management of licenses and certificates, or advice on digital procedures, you will always receive from us a proven experience, ethical commitment, and updated knowledge at the forefront of Panamanian pharmaceutical legislation.
