What are the categories of Pharmaceutical Products in Guatemala?
Regulatory projects for different countries make evident that each Regulatory Authority in the region has different criteria and product categories.
A starting point for a Marketing Approval is to know in which category the product will be classified in the country. The requirements for the process depend on this.
In Guatemala, the Department of Regulation and Control of Medicines published a Technical Standard 21 (Norma Técnica in Spanish), version 2-2023 titled “On the Identification of Pharmaceutical Products”.
It defines the following categories for Pharmaceutical Products:
1. Pharmaceutical Specialty
2. Biological or biotechnological product (includes vaccines)
3. Homeopathic product
4. Radiopharmaceutical
5. Masterful product
6. Official product
7. Medicinal natural product
8. Dietary supplement
9. Medical gas.
This classification applies to the following procedures: New health registration, renewals and post-registration modifications.
The Technical Standard 21 (NT-21) also provides information on the accepted name for products. For example:
-The product name, logos or other phrases must not have therapeutic connotations that could generate confusion in the therapeutic indications / forms of use. (Art. 4.1)
-The name of the product must not cause confusion with another already registered, either in its written form – orthographic similarity – or pronounced – phonetic similarity. (Art. 4.2)
-The commercial name must not be derived from international common names (Art. 4.7.1.2.)
For inquiries on this topic, contact us at regulatory.affairs@scheelconsulting.com
Source: Technical Standard 21, Version 02-2023 “On the Identification of Pharmaceutical Products”, July 2023.
