To certify Good Storage Practices in Peru, the following documents are required: – Client list – Supplier list – List of products being marketed (including registrations, validity, and storage conditions) – Quality manual – Job description manual – Organizational chart – Updated staff list with signatures and initials used by the staff – Environmental sanitation […]
1. Perú: These are the documents required to import the following products: Medicines – Health Registration or Certificate of Registration and Summary Sheet (VUCE) – Certificate of Analysis (batch) – GMP Certificate or equivalent – Official Import Certificate (COI) and RD Authorization for Entry (For psychotropics and narcotics) Biologicals and human plasma derivatives – Health […]
Are you interested in commercializing cosmetic products in Peru? Complying with local regulations is essential to ensure the success of your business. Below, we present a guide with the key steps you must follow to meet legal requirements and ensure that your products comply with Peruvian regulations. Step 1: Company Registration The first step to […]
In Peru and Chile, medical devices are classified based on the potential or residual risks associated with their use. This classification considers criteria such as the duration of body contact, the degree of invasiveness, and both local and systemic effects. Practically, devices are grouped by the level of risk they present, categorized into: Class I: […]
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 […]
Q.F. Idaly Jazminy Morote Guzmán QA Specialist & Biologics and Drug Regulatory Affairs Coordinator SCR Consulting Peru Q.F. Mary Carmen Chuquimia Socpaza Quality Specialist & Regulatory Affairs Coordinator SCR Consultores Bolivia The Pan American Network for Drug Regulatory Harmonization (PANDRH), made up of the Drug Regulatory Authorities of 35 Member States and representatives of the […]
Q.F. Mary Carmen Chuquimia Socpaza Quality Specialist & Regulatory Affairs Coordinator SCR Consulting Bolivia The safety and efficacy of pharmaceutical products are influenced not only by their intrinsic properties, but also by their stability during the manufacturing process. Based on these premises, manufacturers and the Bolivian Drug Regulation Authority must work together to ensure that […]
Q.F. Mary Carmen Chuquimia Socpaza Quality Specialist & Regulatory Affairs Coordinator SCR Consulting Bolivia The safety and efficacy of medicines are influenced not only by their intrinsic properties, but also by their stability during the manufacturing process. Based on these premises, manufacturers and the Bolivian Medicines Regulatory Authority must work together to ensure that all […]
Q.F. Mary Carmen Chuquimia SocpazaQuality Specialist & Regulatory Affairs CoordinatorSCR Consulting Bolivia Food Safety is the guarantee that food will not cause harm to the consumer when prepared and/or consumed, without posing health risks. This condition involves several actors (primary producers, food processors, transporters, food traders and final consumers) along the food chain up to […]
Q.F. Mary Carmen Chuquimia Socpaza Quality Specialist & Regulatory Affairs Coordinator SCR Consulting Bolivia The process of evaluation and granting of the Sanitary Registration of Medicines in Bolivia is responsibility of the “Agencia Estatal de Medicamentos y Tecnología en Salud” of the Ministry of Health and Sports, through the Department of Marketing Authorization, specifically through […]