Under CAFTA-DR, a certificate of origin is not required.  However, the Government of Guatemala has asserted that a CAFTA-DR Certification of Origin must accompany the shipment to receive CAFTA-DR preferences and provides a suggested form and filing instruction. It is strongly suggested to follow this format to avoid problems. For additional information on tariffs, see the Trade Barriers section of this guide and/or visit the FTA Tariff Tool and the FTA Resources Toolbox on our FTA Help Center.

For rules regarding how to complete the CAFTA-DR Certification of Origin, please refer to the Directorate of Administration of Foreign Commerce (DACE) of the Ministry of Economy or read the attachment “Instructivo de llenado” (Spanish only).

Standards and regulations for both local and imported products are the same, except for public markets and other food serving locations that require sanitary licenses but no product registration.

Any local producer, processor, packer, or distributor needs to operate under a sanitary license issued by Food Control at the Ministry of Health. Importers need to be legally registered with an active sanitary license of operations and imported products need to be registered as well.  Labeling is required and imported food products are marketed in Guatemala with a Spanish-language label in accordance with the food law.  Stickers are also allowed.  Stickers would be required to declare name of the product, list of ingredients, and nutritional label if appropriate. Please ensure that the Spanish sticker is legible but does not block the front package or the ingredients list or the preparation instructions.  A retailer who violates the food laws as interpreted by Food Control can be fined up to half the value of the previous day’s total sales.  Furthermore, there have been situations where imports have had difficulty clearing customs when the labels have not been in Spanish.

MAGA maintains lists of approved companies, not plant facilities, at https://visar.maga.gob.gt/

that can export to Guatemala non-processed food products such as poultry, meats, and seafood.  The pre-approved facilities’ requirement does not apply to the United States.  For the United States, the list of exporting companies is constructed and updated as exports come to the country, since the United States was granted food safety equivalence through CAFTA-DR.  Not all importers are aware of this, so please clarify with your importer.

The Foreign Agricultural Service updates every year its GAIN Food and Agricultural Imports Regulations and Standards (FAIRS) Report, where detailed information is provided for exporting agricultural and food products to Guatemala. Please visit the latest GAIN FAIRS report for Guatemala.

To receive an import permit, all imported foods of animal or vegetable origin, fresh or processed, must comply with the following requirements:

• Certificate of Origin for Sanitary Purposes:
  • Plant health certificate (phytosanitary certificate) issued by APHIS if it is a fresh plant food product.
  • Sanitary certificate issued by the Food Safety Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA), if it is meat product, either fresh or processed.
  • Agricultural Marketing Service (AMS) Export Certificate for table eggs, low egg content process products (like omelets), and milk and dairy products.
  • National Oceanographic and Atmospheric Agency (NOAA) seafood and fisheries Export Certificate.

• State Issued Certificate of Free Sale or Food and Drugs Administration (FDA) export certificate if it is a processed food product, either primary or end, which is not a meat product.

• Commercial invoice.
• Bill of lading

• Certification of Origin for customs and tariff purposes. The CAFTA-DR proposed certificate of origin the Government of Guatemala fulfills customs requirements so that preferential tariffs can be applied.

• Re-Export Certificate if the product is re-exported from the country, but please note that it still requires the original sanitary or phytosanitary certificate.

The Certificate of Free Sale can include a list of products to be registered, if all the products in that list are registered simultaneously.

For example, if twenty products are to be registered at the same time, Food Control allows for one original certificate and nineteen copies to accompany the rest of the products, since one complete file is kept per registered product.

Central American Technical Regulations (RTCA) – As part of the Central American harmonization process, Ministries of Economy have published the RTCAs that spell out technical regulations for packaging, labeling, liquors and spirits, approved additives, infant food, sanitary license, and registration of products.  Though the regulations are the same for all Central America, their implementation varies from country to country.  Please, refer to FAS export certificate report to get more detailed information on the U.S. export certificates approved in Guatemala and additional information required to comply with Guatemala import requirements and standards.

Contact Information

Interested parties may contact Agricutural Specialist Karla Tay at KayTM@state.gov  or Commercial Specialist Antonio Prieto at antonio.prieto@trade.gov

Medical Devices, Pharmaceutical Products and Cosmetics

The Division of Registration and Control of Medicines and Foods of the Ministry of Health issues import permits for medical devices, pharmaceutical products, and cosmetics.

Some products require an inscription (registration) at the registration office of the Ministry of Health.  The approximate amount of time for the registration of a medical device is between 2-3 weeks and for pharmaceuticals and 4-6 months for cosmetics. These inscriptions need to be renewed every five years.

Surgical devices that require an inscription are intended for cutting the skin or a membrane, or which touch blood, such as syringes or finger pricks.  Devices such as anesthetics and asthmatic inhalers, high pressure measuring apparatus, laser-guided apparatus and others do not require an inscription. These would be classified under medical equipment and supplies and undergo normal customs clearance procedures.

The Central American Technical Regulations, CATR (RTCA in Spanish) have been recently issued and published for processed food products, pharmaceuticals, and cosmetics, among others. The CATR established unified standards and requirements for commercializing agricultural products, pharmaceuticals, cosmetics, healthcare products and others within the Central America and Panama region. Compliance with these technical regulations assures that products may be imported without major complications.

For more information on these technical regulations, please visit: 

https://medicamentos.mspas.gob.gt/

Registration Requirements for Pharmaceutical Products

Pharmaceutical products, including but not limited to specialty pharmaceuticals, homeopathic, radiopharmaceutical, supplements, biological, biotechnology and allergens require a Sanitary permit to be imported and commercialized in Guatemala.

Details and registration forms for pharmaceutical products and renewal process may be found in the following link: Registro e Inscripción (mspas.gob.gt)

A simplified list of requirements for obtaining a sanitary permit is below: *

1.  Fill and submit the appropriate forms in original and duplicate

2.  Product formula and composition (mention both common and scientific names) (using appropriate form)

3.  Sanitary license, valid or prior license (usually from FDA or PAHO)

4.  Legalized copy of the Trademark registry

5.  Free Sale Certificate from the country of origin; CBL approved by a recognized organization such as the OMS

6.  Monograph study, when it is a new product

7.  Product description

8.  Product specifications

9.  Method of analysis used

10. Packaging materials used (a sample), originals and copy

11. Instructions on label in Spanish

12. Copy of contract (in case of manufacture under drawback or “maquila” law)

13. Stability study for products with 24 months life expectancy or more, according to product

14. Samples

15. Bio-equivalence study, when applied

16. Standard of raw material of active principle/s for new molecules

17. Copy of the Sanitary License of the local distributor

18. All foreign language documents must be legally translated into Spanish.

*This is a simplified guide; it is recommended that the U.S. company visits the appropriate links to obtain updated and specific guidance on how to register products.

Registration Requirements for Medical Devices, Dental Materials, Laboratory

Reagents:

Details and registration forms for these products may be found in the following link Registro e Inscripción (mspas.gob.gt) under subtitle: “F-AS-f-08: Solicitud de Inscripción Sanitaria de Productos Afines”

Cosmetics

Authorization to commercialize cosmetic products in Guatemala is required, and the owner of the sanitary registration must be a local company.  It is recommended that the U.S. exporter find local representation to take care of the ownership of its sanitary registrations.

When products are registered under a distributor’s name, and the U.S. Company determines that there is a need to change the distributor, it is necessary to present a document or contract, signed by both parties to the Ministry of Health.

If the U.S. Company owns the sanitary registrations through a local representative or company and chooses to change a distributor, such change must be notified to the Ministry of Health; this is a simple procedure.

Some requirements for sanitary registration include, but are not limited to:

• Good Manufacturing Practices: This document must be filed once for all the products manufactured by the same Company. It must be issued by the Health Authority or similar authority in the country/state of origin of the product. If this document is not issued by the Health Authority or similar, a Sanitary License of the Manufacturer may be accepted.

• Qualitative and Quantitative Formula: This document must be issued by the producer/manufacturer and must be signed by a responsible person (responsible professional in the Company).

Finished Product Specifications

This information may be contained in the Analysis Certificate. The document must include the physical specifications of the product: (odor, color, appearance), and the chemical and microbiological specifications.

Information

Interested parties may contact Commercial Assistant Karla Salas at karla.salas@trade.gov