Types of Drug Products in Guatemala

Which cathegory applies to a product i wish to register?

This is a common question when considering the registration of a product in Guatemala, so let’s review the current legal framework.

According to Technical Standard No. 7 on Drugstores, Version 05-2023, which came into effect on July 21, 2023, the categories are as follows:

Pharmaceutical Product (Art. 2.20): “A simple or compound substance, natural or synthetic, or a combination thereof with a defined pharmaceutical form, used to diagnose, treat, prevent diseases or modify a physiological function in humans.”

Controlled Pharmaceutical Product (Art 2.22): A pharmaceutical product whose importation and sale is monitored by the Department. The use of these products can lead to addiction. Controlled substances include opioids, stimulants, depressants, hallucinogens, and anabolic steroids. Controlled pharmaceutical products can only be dispensed with a medical prescription.

Productos afines (can be translated as associated products) (Art. 2.19): “(…) cosmetics, personal hygiene products, sanitary products, healing and medical-surgical materials, diagnostic laboratory reagents, dental products and equipment.”

Consider the hypothetical example of a cream that you have registered in another region as a cosmetic.

Depending on the product’s indications and formula, the authority might classify it as a pharmaceutical product. In such cases, it’s essential to compare the product’s formula with current regulations. This is one of the services we offer at Scheel Consulting.

If you’d like to make an inquiry, you can email us at regulatory.affairs@scheelconsulting.com.