OPENING COMMERCIAL PHARMACIES IN BRAZIL: DOCUMENTATION AND REGULATORY REQUIREMENTS

Abstract

The opening of commercial pharmacies in Brazil is a fundamental process for promoting public health, yet it is marked by a complex regulatory framework. This study aimed to analyze and systematize the essential steps, documents, and legal requirements for the regularization of these establishments, serving as a practical guide for entrepreneurs in the sector. The methodology adopted a qualitative approach, based on documental and bibliographic research of primary sources, resolutions from ANVISA and the Federal Council of Pharmacy, and technical guides from SEBRAE. The results were structured into a step-by-step roadmap that details each phase of the process, from business registration to obtaining the Company Operation Authorization (AFE). It was evidenced that, despite bureaucratic challenges and the costs involved, regulatory compliance provides crucial advantages such as legal security, market credibility, and the possibility of expanding pharmaceutical services. It is concluded that the rigorous regularization process is a pillar for consumer safety and the quality of healthcare, reaffirming compliance with standards as an essential factor for the sustainability and legitimacy of the pharmacy as a health establishment.