Sandra Ortiz
Compliance with the health provisions established by Guatemalan law is essential to guarantee the safety and legality of products sold in the country. In this regard, all medicines, food, supplements, or related products must have a health permit issued by the Ministry of Public Health and Social Assistance (MSPAS) before they can be distributed, marketed, or imported.
Health registration is not only a legal obligation but also a guarantee of quality, safety, and traceability for consumers, distributors, and authorities. Compliance with this requirement avoids penalties, customs holds, and other administrative contingencies that can affect the operation and reputation of companies.
In the food sector, the Ministry has recently introduced the National Food Health Registration System (SNRSA-G), a digital tool that seeks to modernize and streamline the processes of registration, renewal, and modification of food products. This platform represents a significant step forward in the electronic management of health records, promoting transparency, efficiency, and traceability in procedures.
In light of this technological and regulatory update, a specialized advisory and comprehensive support service is available to operators in the sector for the registration, renewal, and updating of health permits for both pharmaceutical and food products. This service is designed to facilitate regulatory compliance, optimize processing times, and ensure the correct implementation of the procedures established by the MSPAS.
Strengthening the health culture and regulatory compliance are essential pillars for the development of a more competitive, responsible market that is aligned with international standards. For this reason, the correct implementation of the SNRSA-G system requires that health records be accompanied by accurate technical documentation.
In this regard, the Technical Data Sheet (TDS) plays an essential role, and we have recently identified that customers are often unaware of the importance of this document. This document is essential in any export or import project, as it contains key information for both commercial purposes and regulatory compliance.
Once a product innovation has been validated as acceptable and effective, it is essential to have its Technical Data Sheet, as this document not only supports marketing but is also indispensable for the management of health records.
The purpose of the Product Technical Data Sheet is to clearly communicate the characteristics and specifications of the product, covering both technical and commercial aspects.
Who should prepare it?
Generally, the manufacturer has the necessary information to prepare it. However, the importer or exporter must also be familiar with and have access to this document, as its content is vital for proper marketing and regulatory compliance.
In our experience advising on import and export structures, we have observed that many clients are unfamiliar with this document. This is often because products are sometimes marketed without a formal technical data sheet, even though relevant information is available, such as:
- Product identification: commercial, technical, or scientific name (in the case of products of plant or animal origin).
- Technical data: composition, physical and chemical characteristics, density, among others.
- Commercial data: presentation, varieties, uses, type of packaging, etc.
It is important to note that the Product Technical Data Sheet is no longer a purely commercial document. In many countries, health authorities require it as part of the file necessary to obtain health registrations.