PANAMA Trends and Developments Contributed by: Rafael Rivera, Malvis Mina, Nicole Pérez and Carolina Lino, BDO Panama
This judgment establishes a significant prec - edent regarding the use of CPCs and the refund process for ITBMS in Panama, stressing the importance of accurate reporting by taxpayers to qualify for these tax benefits. New Sanitary Registration Procedures Law 419 introduces a new sanitary registration procedure in addition to the existing regular and abbreviated procedures, as well as mutual rec - ognition. The newly established procedure is specifically designed for innovative medicines, allowing for a more expedited registration pro - cess for such products in Panama. Furthermore, the Law formally recognises vari - ous Central American Technical Regulations concerning the requirements and procedures for obtaining sanitary registration in the country, thereby promoting regional harmonisation and regulatory efficiency. Expedited Registration Via WHO-Listed Authorities In 2025, Executive Decree No 2 of 7 January 2025 introduced an additional expedited regis - tration pathway. This procedure allows for the recognition of sanitary registrations for medi - cines approved by regulatory authorities includ - ed in the World Health Organization’s List of Authorities (WHO WLA). Under this mechanism, the standard registration timeline – which may extend up to one year – is reduced to just ten business days, provided there are no objections from the National Direc - torate of Pharmacies and Drugs. This significant - ly accelerates market entry for eligible products.
To qualify for this expedited process, the follow - ing conditions must be met: • the product must be manufactured in a coun - try whose regulatory authority is listed in the WHO WLA; and • the product must be registered in a coun - try with a WHO WLA-recognised regulatory authority. One of the key benefits of this procedure is the exemption from laboratory analysis in Panama, which is typically time-consuming. However, this exemption only applies if the product is both registered and marketed in a WLA-listed country. It is important to note that even if a regulatory authority is included in the WLA, it must meet all product-specific regulatory requirements. For example, vaccines from a given country may qualify, while chemically synthesised medicines may not – each case must be assessed individu - ally. Recognition of Well-Known Trade Marks Panama’s Industrial Property Law recognises the concept of well-known trade marks. However, it previously lacked a formal procedure for their recognition by competent authority. As a result, applicants had to argue and request such rec - ognition in each individual case, with the effect limited to the specific proceeding. In 2024, the Ninth Civil Circuit Court of the First Judicial District of Panama issued a landmark ruling recognising, for the first time, a well-known trade mark with general effect within one of the classes of the Nice Classification.
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