Consideration must be given to certain steps such as legalization of documents and the period in project timelines when submitting documents for marketing authorization in several countries in Latin America. This also includes a wide range of GMP certification requirements and variation in the need to present certification for only one product or for intermediates of that product or active pharmaceutical ingredient (API).

The requirements to present GMP certificate in drug products marketing authorization submissions are very briefly described below for Chile, Cuba and Venezuela.

Chile and Cuba
Local authorities in these countries require the submission of GMP certificate for the drug product and accept the document issued by the authority of the country where the manufacturing site is located.

Venezuela
The regulatory body in charge of approving medicines in Venezuela is the National Institute of Hygiene Rafael Rangel (Instituto Nacional de Higiene Rafael Rangel, INHRR).

INHRR requires the presentation of GMP certificate for the drug product and accepts the document issued by the authority of the country where the manufacturing site is located.

Considering local experience, although not defined in the requirements checklist, presentation of the API GMP certificate was required for a new molecule in the country.

This article is the last of a series of four articles on the certification of GMP requirements in different countries in Latin America.

Related articles
GMP certification requirements in Central American countries

GMP certification requirements in Andean Community countries

GMP certification requirements in Argentina, Brazil and Mexico

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Reference
1. U.S. Food and Drug Administration. Facts about the current good manufacturing practices (CGMPs). 2018 [homepage on the Internet]. [cited 2021 Oct 8]. Available from: https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps

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