To import pharmaceutical products into Uruguay, companies must obtain authorization from the Ministry of Public Health (MSP). This process involves registering the pharmaceutical specialty and obtaining approval for its sale within the country. The registration process requires the submission of detailed product information, including composition, manufacturing processes, and clinical data, to demonstrate the product's safety and efficacy. Additionally, the MSP requires that imported pharmaceutical products comply with Good Manufacturing Practice (GMP) standards. GMP certification from recognized authorities, such as the European Union (EU) GMP, World Health Organization (WHO) GMP, or Pharmaceutical Inspection Co-operation Scheme (PIC/S), is typically recognized by the MSP. Importers must ensure that their suppliers hold valid GMP certifications to facilitate the importation process. Furthermore, companies must obtain wholesale distribution authorization from the MSP, which involves meeting specific requirements related to storage, handling, and distribution practices to ensure the integrity and quality of pharmaceutical products throughout the supply chain.
