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Regulatory Changes to the Regulation of Pharmaceutical Establishments: Key Provisions of Supreme Decree No. 008-2025-SA

Prepared by Carolina Núñez – Associate Consultant in Quality Assurance and Regulatory Intelligence On Friday, June 13, 2025, the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) convened stakeholders from the pharmaceutical sector to present the scope of Supreme Decree No. 008-2025-SA, which modifies key articles of the Regulation of Pharmaceutical Establishments (Supreme Decree No. […]

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Requirements for Opening a Pharmaceutical Establishment, Drugstore, or Importer in Peru, Bolivia and Chile

Peru: In Peru, there are 11 requirements to open a pharmaceutical establishment/Drugstore/Importer, as follows: Establish a company and obtain a RUC (from SUNARP, SUNAT) for both legal entities and individuals. Employ a licensed pharmacist who will serve as the Technical Director (TD). Have a facility that includes an administrative area and a third-party or in-house […]

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