On April 28, 2021, the Technical Standard 09-2021, Version 2, SANITARY REGISTRATION OF INDUSTRIALLY MANUFACTURED OFFICIAL PHARMACEUTICAL PRODUCTS, was published on the website of the Guatemalan Ministry of Health, which aims to regulate the conditions and requirements for granting the sanitary registration of an industrially manufactured officinal pharmaceutical products, listed in the annex of the aforementioned document. This Standard became effective as of the date of publication, thus repealing Technical Standard 09, Version 01-2012, dated August 09, 2012.
The same applies to all those products industrially manufactured in Guatemala and for those imported from abroad, by any type of natural or legal person, excluding fractionated pharmaceutical raw materials, natural medicinal products, cosmetics, and hygienic products, forming part of this Annex with the Reference List of Official Products.