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 warehouse
that complies with Good Storage Practices (GSP) guidelines. - Start the registration process for the establishment through Form A-2, “Application – Sworn
Statement for the Sanitary Authorization of Drugstore Operation,” from the General
Directorate of Medicines, Supplies, and Drugs (DIGEMID), attaching the necessary documents. - Pay the processing fee at Banco de la Nación, at health rate 6556.
- Submit the documentation through the appropriate channels.
- The process is subject to prior inspection, and the evaluation period is 30 working days.
- Once DIGEMID schedules the inspection, inspectors will verify all the establishment’s
documentation and the warehouse infrastructure. - Upon approval, the Directoral Resolution for the Sanitary Operation Authorization and a
provisional GSP certificate valid for 6 months will be issued. - Apply for the renewal of the GSP certification at least 45 days before expiration.
- Once registered as a Drugstore, you may begin operations, and the TD can manage the sanitary
registrations for the products to be imported or request Sanitary Registration Certificates.
Bolivia:
In Bolivia, the requirements to open a pharmaceutical importer of recognized medicines
include:
- Submit company documents such as Form 003, the NIT (Tax Identification Number) certificate,
and others. - Present the professional profile of the Regente (Professional in Biochemical Pharmacy,
Pharmaceutical Chemistry, or Pharmacy), including legal copies of their diploma, working
contracts, and other necessary credentials. - Establish a company with a NIT and hire a licensed pharmacist as the Regente.
- Ensure the facility complies with Good Storage Practices (GSP).
- Begin the registration process through Form 003 and pay the required fees per Ministerial
Resolution No. 265, item No. 26. - Submit the documents to AGEMED for review and inspection.
- Once approved, obtain the Sanitary Operation Authorization and start business operations.
Chile:
In Chile, the requirements to open a Drugstore include:
- Establish a company and obtain a RUT.
- Hire a licensed pharmacist to serve as the Technical Director (TD) of the establishment.
- Have a properly equipped facility that meets the storage and conservation standards according
to current regulations. - Submit architectural plans for the establishment for evaluation by the Public Health Institute
(ISP), pay the respective fee, and attend an evaluation session. - Once the plans are approved, request an installation authorization, pay the respective fees, and
submit the required documents. - Upon approval, the authorization is valid for 3 years, with automatic renewals for equal and
successive periods. - After receiving the final approval, the establishment may begin operations.