On August 01, 2023, it was published by the Department of Regulation and Control of Pharmaceutical and Related Products, of the Ministry of Health of Guatemala, the Technical Standard 21 Version 02-2023, On the Identification of Pharmaceutical Products.
It contains various regulations regarding the name of pharmaceutical products, among which it is important to mention:
- A section of general provisions is developed, indicating that:
- The name of the product cannot have therapeutic connotations, nor can it cause confusion with another already registered product.
- The primary, secondary and insert labeling must match the application form being entered. Being able to place for generic products the marketing line, name of the manufacturer or owner through logos or designs.
- It is not allowed to place the presentations of the product as part of the name of the product.
- It is possible to add the type of container or applicator to the name, example: Roll on, bar, injectable pen, etc.
- Indicates some specifications regarding the Trade Name or Brand Name, such as:
- It should not be confused with a common name, nor include therapeutic properties.
- The mixture of trade name and generic name as part of the denomination is not allowed.
- The registration of a phonetically or orthographically similar product to another already registered is not allowed.
- Trade names consisting only of letters, numerical codes or punctuation marks are not accepted.
- The use of a commercial name that has been previously registered and that is expired/cancelled is not accepted, but until 10 years have elapsed from expiration.
- Regarding the Generic Name, it mentions:
- The name must be in Spanish and conform to the International Nonproprietary Name (when applicable).
- It must be added to the name of the product one of the following options to this:
- Name of owner.
- Manufacturer's name.
- Marketing line.
- It is indicated that the denomination of the Natural Medicinal Products must be a scientific name, common name or trade name.
- In the case of Dietary Supplements, the name or logos must not have therapeutic connotations.
- For products with a Trade Name that also request to be marketed under an International Common Name or vice versa, separate (individual) Sanitary Registrations must be processed.
- It allows that if it is not possible to comply with the requirements indicated in the Regulations, the case is submitted for evaluation by the Department of Regulation and Control of Pharmaceutical Products, attaching the respective justification.
- Establishes a table with the guidelines for the conformation of the product name:
| Product name structure | |||||||||
| optional term | mandatory term | optional term | optional term | mandatory term | optional term | mandatory term | mandatory term | optional term | |
| Prefix Applies only | Name of the product Applies for commercial or generic name | Therapeutic action/Therapeutic group Applies to over-the-counter products | Suffix Applies for commercial or generic name | Name or initials of manufacturer/owner (mandatory for generics) Applies to commercial or generic names | Type of container/applicator Applies for commercial or generic name | Concentration (dose unit/administration unit) Applies to commercial or generic name (max. three active ingredients) | Pharmaceutical form/Finished form Applies for commercial or generic name | Aroma/color/flavor Applies to commercial or generic name | |
- It also provides us in Annexes 1, 2 and 3, examples of Prefixes, Therapeutic Indications and Suffixes that can be used as part of the product name.
This new article repeals Technical Standard 21 version 01-2002 dated August 02, 2002, and will enter into force on September 01 2023