By SCR Consulting Fiorella De la Cruz Huamán, Consultant & Comercial and Marketing Head of SCR Consulting At the end of August, SCR Consulting had the privilege of attending, as an associate, the presentation of the Commercial Intelligence Study conducted by the “Gremio de Cosmética e Higiene Personal” (COPECOH) of the Lima Chamber of Commerce […]
The Andean Technical Regulation sets clear guidelines to ensure the quality and safety of cosmetic products manufactured, packaged, or processed in the member countries of the Andean Community. This regulation applies to all companies and establishments involved in the production, packaging, or processing of cosmetics, including imported products, which must comply with the established Good […]
– Pharmacovigilance audit activities should verify, based on the examination of objective evidence, that the pharmacovigilance system is adequate, effective, and complies with the criteria established in national regulations. For a successful audit, it is recommended to: – Have an email and phone number dedicated to the pharmacovigilance department of the establishment. – Inform DIGEMID […]
To certify Good Distribution and Transportation Practices in Peru, the following documents are required: – Client list – Supplier list – List of products being marketed – Quality manual – Job description manual – Distribution service contract – List specifying storage and packaging conditions for proper preservation during the transportation of pharmaceutical products, medical devices, […]
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 […]