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.
It is key to double check that the correct “preferential criteria” is included in space # 7 of the suggested form. Importers have been denied the preferential tariff for incorrect criteria designation.
The preferential criterion corresponds to letters “a”, “b”, or “c”, according to Chapter 4 - Rules of Origin.
If either the exporter or the importer does not know which criterion applies, the Ministry of Economy is willing to review the product description with the importer to determine the correct criterion.
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).
As of December 2005, the Guatemalan Ministry of Economy’s National Quality System became the standard setting body and manages the Guatemalan Accreditation Office (OGA) and the National Metrology Center (CEME). Prior to December 2005, the Guatemalan Norms Commission (COGUANOR) set standards, but when the National Quality System came on board, COGUANOR standards became voluntary. The Guatemalan Accreditation Office (OGA) is governed by Presidential Decree 145-2002 and is responsible for the accreditation of laboratories and certifying entities and inspection organizations.
Presidential Decree 78-2005 establishes official tariffs for the services provided by the OGA, which is a signatory to the “Multilateral Recognition of the Inter American Cooperation for Accreditation” (IAAC) and has been accepted in the “Mutual Agreement of Recognition of the International Accreditation for Laboratories” (ILAC).
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) 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:
a) Certificate of Origin for Sanitary Purposes:
i. Plant health certificate (phytosanitary certificate) issued by APHIS if it is a fresh plant food product.
ii. 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
iii. Agricultural Marketing Service (AMS) Export Certificate for table eggs, low egg content process products (like omelets), and milk and dairy products.
iv. National Oceanographic and Atmospheric Agency (NOAA) seafood and fisheries Export Certificate.
b) 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.
c) Commercial invoice.
d) Bill of lading
e) Certification of Origin for customs and tariff purposes. The CAFTA-DR proposed certificate of origin b the Government of Guatemala fulfills customs requirements so that preferential tariffs can be applied.
f) 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.
OFFICIAL CONTACTS
Name: Karla Tay
Title: Agricultural Specialist
Institution: Foreign Agricultural Service, U.S. Department of Agriculture
Address: Avenida Reforma, 7-01, Zona 10. Edificio Embajada Americana
01010
Telephone: (502) 5326-0005
Email: TayKM@state.gov
Name: Evelyn Meneses
Title: Food Control Officer
Institution: Food Control Unit/Ministry of Health (MSPAS)
Address: Avenida Bolivar, 28-07 Zona 8
01008 Guatemala
Telephone: (502) 22964026
Email: emeneses@mspas.gob.gt
Name: Jorge Gomez
Title: Plant Health Director
Institution: Norms and Regulations Unit/Ministry of Agriculture (MAGA)
Address: 7 Avenida 3-67, Zona 13
01013 Guatemala
Telephone: (502) 2413-7389
Email: jgomez@maga.gob.gt
Name: Nelson Ruano
Title: Food Safety Director
Institution: Norms and Regulations Unit/Ministry of Agriculture (MAGA)
Address: 7 Avenida 3-67, Zona 13
01013 Guatemala
Telephone: (502) 2413-7389
Email: mvnelsonru@yahoo.com
Name: Khrista Polanco
Title: Animal Health Director
Institution: Norms and Regulations Unit/Ministry of Agriculture (MAGA)
Address: 7 Avenida 3-67, Zona 13
01013 Guatemala
Telephone: (502) 2413-7389
Email: kpolanco@maga.gob.gt
Name: Dra. Nidia Sandoval
Title: Director OIRSA-SEPA-SITC
Institution: Inter-Regional Body for Plant and Animal Health/Ministry of Agriculture (MAGA)
Address: 21 Avenida 3-12, Zona 15, Guatemala
Telephone: (502) 2369-5900
Fax: (502) 2334-0646
Email: nsandoval@oirsa.org
Name: Licda. Victoria Meza
Title: CAFTA-DR Administrator
Institution: Foreign Commerce Administration Direction/Ministry of Economy
Address: 6 Avenida 10-43 Zona 1, Guatemala
Telephone: (502) 2412-0200
Email: vmeza@mineco.gob.gt
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.
In Guatemala, 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.
Original labels or its projects
Original Labels
Labels must be in Spanish.
If they are in English, they should be translated by a legal translator, and the relevant information must be bonded to the product.
Power of Attorney
This document must be apostilled, or legalized, by a Guatemalan Consulate in the United States.
The Power of Attorney will allow a third party to sign in the name of the foreign company, and it must also specify a person that will be responsible for any sanitary eventuality when importing and commercializing the product in Guatemala.
Apostille
This is an international certification comparable to a notarization in U.S. domestic law, and normally supplements a local notarization of the document. In the United States, the Secretary of State is responsible for the apostille procedure for all public documents.
Additional Requirements
When a product has an active ingredient that exceeds the maximum percentage permitted by Law, the manufacturer is required to issue a letter declaring whether the ingredient is pure or part of a blend. Guatemala requires a distributor, with valid sanitary permits, to have the proper facilities to import and storage cosmetic products.
Source: “Sanitary Registration of Cosmetic Products in Central America” by Unimark Law Firm, https://www.unimarkip.com/
Details and registration forms for cosmetic products may be found in the following link:
https://medicamentos.mspas.gob.gt/index.php/formularios/registro-e-inscripcion
under the following subtitle:
“F-AS-f-08: Solicitud de Inscripción Sanitaria de Productos Afines”
Validity and Renewal
The sanitary registration is valid for five years. It can then be renewed for five more years. The renewal procedure must be initiated before its expiration, and the requirements for the renewal process may be found at https://medicamentos.mspas.gob.gt/index.php/formularios/registro-e-inscripcion
under the following subtitles:
“F-AS-f-05: Solicitud Renovación de Registro” (Renewal)
“F-AS-f-09: Solicitud Actualización de Registro” (Update)
The Division of Registration and Control of Medicines and Foods of the Ministry of Health generally does not reply to inquiries via email or telephone. A request for personal appointments is highly recommended.
U.S. businesses that have an experienced and strong representative in Guatemala will find that this is the best means to easy registration in the country.
For more information, please refer to:
Dirección General de Regulación, Vigilancia y Control de la Salud,
Departamento de Regulación y Control de Productos Farmacéuticos, Higiénicos, Quirúrgicos y Cosméticos
Elizabeth Cesino de Pozada, Head of Department