Press Room

LABELING OF PHARMACEUTICALS IN GUATEMALA

August, 2014

We inform you that on May 21st of this year, the COMIECO resolution number 340-2014 taken by the Cabinet of Economic Integration in which it was agreed to amend by adding to the Central American Technical Regulation RTCA No. 11.01.02:04 Pharmaceuticals, was published in the official Gazette. Pharmaceutical Labeling, which now states: "Gluten. Drugs that contain traces of gluten or gluten containing sources, for example wheat, starch, oats, barley, rye or triticale and its derivatives, should add a legend equal to or similar to the following: Caution contains gluten."

As a result of this modification, a transitional article was added to the RTCA referred to above, which will require that medication containing traces of gluten or gluten containing sources that are already on the market, will have a period of 12 months from the publication of the resolution above indicated to implement the legend on the package labeling.

For additional information on this topic, please contact us:

Liz Gordillo Anleu at liz.gordillo@ariaslaw.com
Jorge Alfredo Marroquín at jorge.marroquin@ariaslaw.com

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