User Guide for Applying for the Sanitary License for Establishments / NICARAGUA

Dear all,

In accordance with the User Guide for applying for the Sanitary License of establishments engaged in manufacturing, exporting, importing, distributing, and marketing products regulated by the Directorate of Pharmacy, issued by the National Health Regulatory Authority (ANRS) of the Ministry of Health of Nicaragua and published on March 13, 2026, we hereby inform you:

  1. The objective of the guide is to establish the legal and technical requirements for submitting applications in the Karplus System for the authorization of Sanitary Licenses for establishments engaged in manufacturing, exporting, importing, distributing, and marketing products regulated by the Directorate of Pharmacy.
  1. The scope of the guide covers the process from obtaining the requirements, submitting the application for establishment authorization, to the approval of the Sanitary License for Operation.
  1. It includes the detailed requirements for submitting applications for authorization of establishments classified as manufacturing laboratories, distributors, importers, and those for internal consumption.
  1. Information to be included in the establishment authorization application:

4.1 Establishment Information

4.2 Legal Representative Information

4.3 Responsible Pharmacist Information

  1. Steps to follow for submitting the establishment application:

5.1 Obtain username and password for the Karplus System

5.2 Payment for the opening fee of the Sanitary License for Operation

5.3 Application for opening the Sanitary License for Operation

5.4 Resolution of the application for opening the Sanitary License for Operation

5.5 Inspection request

5.6 Issuance of the Sanitary License for Operation

  1. All information related to the opening of establishments is available on the website www.minsa.gob.ni under the Publications section of the National Health Regulatory Authority – Directorate of Pharmacy, or by contacting the emails farmaciadir@minsa.gob.ni and divfar@minsa.gob.ni.

For any additional questions, please feel free to contact us.

Kind regards.

 

Brenda Aguilar

 


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