Includes import documentation and other requirements for both the U.S. exporter and foreign importer.

The Government of Guatemala has asserted that a CAFTA-DR Certificate of Origin must accompany the shipment to receive CAFTA-DR preferences.  (See: http://www.mineco.gob.gt/certificado-de-origen ). 

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 Certificate 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).

The Division of Registration and Control of Foods of the Ministry of Health, here after referred to as Food Control, is the main authority for food products legally imported or manufactured in Guatemala. Government Decree # 45-79 established the Health Code in 1979, later published and updated under Government Decree 90-97.  Chapter Five of the Health Code refers to food products.  Food Control, under the authority of Ministerial Decree 969-99 (which replaces Decree 132-85), is responsible for upholding food product norms set by the Guatemalan Ministry of Economy’s National Quality System, which is governed by Law 78-2005. Under the National Quality System, administered by the Ministry of Economy, three offices operate: The Standard Commission, COGUANOR; the Guatemalan Accreditation Office (OGA), and the National Metrology Center (CEME) https://www.mineco.gob.gt/direcci%C3%B3n-del-sistema-nacional-de-la-calidad.

The COGUANOR office, prior to December 17, 2005, was the sole entity responsible for setting obligatory standards regarding processed food, but after the establishment of the National Quality System, COGUANOR kept the mandate exclusive for voluntary standards. The National Quality System has approved standards since December 17,2005; prior to which standards were not modified and appeared as COGUANOR norms. The OGA, (governed by Presidential Decree 145-2002,) is responsible for accreditation of laboratories, certifying entities and inspecting 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).

There are many specifications, rules, laws and other requirements regulating food products.  Decree 969-99 details various regulations related to food safety.  Standards 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.

Product Registration is required for all primary and final processed food products in Guatemala.  Food Control is responsible for all registrations. There are many food regulations approved under the Central American Customs Union, which apply to Guatemala.

Sanitary registration, a requirement throughout Central America, is causing increasing delays. The Government of Guatemala is requesting registration of primary processed food products under the same procedure that applies for registration of end processed food products; additives do not need to be registered. The Government of Guatemala has also set in place a mechanism known as "sanitary inscription for registered products," which allows for an extension option of already existing registries, for different companies. For example, if company 1 registers brand "x", and the registration number 1520-1 is assigned, company 2 can register the same brand "x" under the 1520-2 registration number. This mechanism allows for:  a) title of ownership of the registered product, but not over the brand, allowing for different importers/distributors to commercialize the same product (exclusive distribution is left in the hands of commercial interests and not for regulatory purposes); and b) title of ownership of the registration and sole responsibility for the registration.  For example, if for any reason, registration number 1520-1 has any specific issue (labeling, license status of the importer, food safety or other), only company 1 is affected. Besides the title of the ownership component, the "sanitary inscription for registries" also expedites the registration process -especially in the case of animal products- since the extension is granted immediately given the fact that the first registration number has already passed the laboratory analysis.  The registration, in this case number 1520, is valid for five years, independent of when the extension was granted, and all extensions of this registration must be renewed every five years.

Food Control issues a sanitary registration number after a laboratory test has been performed on animal products. This registration number is valid for five years and in the case of animal products, takes at least six weeks to be issued.  For other processed products not of animal origin, the registration takes approximately 10 days.   Laboratory tests will take place routinely and are scheduled once a year per product category.  If products do not comply with labeling standards or food safety parameters, importers will be notified as necessary.  Non-animal products do not require a phyto- or sanitary certificate; a Certificate of Free Sale applies in this case. The Certificate of Free Sales is required for registration purposes only, and can be a federal or state document.

For registration purposes, the sample must come with the following documentation: a) Certificate of Free Sales, b) Bill of Lading, and c) Invoice (with any negligible quantity) specifying it is only a sample.  If the product to be registered is non-animal origin, registration will take between 10-12 days; for animal origin products, registration might take up to one month.

In addition to the laboratory analysis for animal products, (for the wholesomeness of the product) the law requires inspections at the point of entry, wholesale and retail levels.  Non-processed foods and food additives do not require registration. There is no environmental legislation that affects the importation of food products. The cost of registration and analysis of a product is about USD 215, independent of its category, and independent of registering it for the first time or requesting an extension of an already existing registration.

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)            Certificate of Free Sale 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)            Certificate of Origin for customs and tariff purposes. The CAFTA-DR certificate of origin 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, as long as 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.

The Unit of Norms and Regulations (UNR) of the Ministry of Agriculture, Livestock and Food Security (MAGA) controls all of these requirements and issues the import permit. Import forms are available on-line at: http://visar.maga.gob.gt/?page_id=6215.   If the certificate cannot attest against specified quarantine pests, it might not be considered valid and the shipment might not receive an import permit or worse, its entry might  be forbidden, even if the shipment has arrived at a Guatemalan port.  Your APHIS inspector should verify that the Phytosanitary Certificate includes specific attestation when required.

Microbiological - On July 19, 2009, the Government of Guatemala (GOG) published their Central American Technical Rule (RTCA):
67.04.50:08. This ruling establishes the maximum level of food-borne pathogens permitted in processed and unprocessed food and agricultural products. The following website has further information: https://www.sieca.int/index.php/download/resolucion-no-402-2018-aprueba-rtca-67-04-5017-alimentos-criterios-microbiologicos-inocuidad-de-alimentos/ . Compliance with the microbiological criteria spelled out in the RTCA started being enforced on November 19, 2009. Compliance with the microbiological parameters will be determined during the registration process or during surveillance using laboratory analysis.  Most plants in the U.S. already have systems in place to measure microbiological profiles as part of their Hazard and Critical Control Points (HACCP) programs. It is recommended to send the most recent report with the sample that will be used for registration purposes.

Under CAFTA-DR, the U.S. meat and poultry inspection system was recognized as equivalent by MAGA, so FSIS Certificate of Wholesomeness (FSIS 9060-5) is accepted by the Government of Guatemala as a Certificate of Free Sale and/or Sanitary Certificate, according to the specific case of a meat processed product and/or fresh meat 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 of Central America, their implementation varies from country to country.  Please, refer to the following web site to assure compliance with presently enforced technical regulations:
https://www.sieca.int/index.php/integracion-economica/instrumentos-juridicos/actos-administrativos/consejo-de-ministros-de-integracion-economica/resoluciones/ .

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) 2332-4030
Website: https://gt.usembassy.gov/es/embassy-es/guatemalacity-es/sections-offices-es/oficina-de- 
                                 asuntos-agricolas/

Name:                    Bernardo Molina
Title:                       Director for Regulations
Institution:            Food Control Unit/Ministry of Health (MSPAS)
Address: Avenida Bolivar, 28-07 Zona 8
                                01008 Guatemala
Telephone:            (502) 22964026
Website:                https://www.mspas.gob.gt/index.php/component/jdownloads/category/252-control-de-alimentos?Itemid=-1   

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
Website: visar.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
Website: visar.maga.gob.gt

Name:                    David Orellana
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
Website: visar.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
Website: www.oirsa.org

Name:                    Lic. Alexander Cutz
Title:                      CAFTA-DR Administrator
Institution:            Foreign Commerce Administration Direction/Ministry of Economy
Address: 6 Avenida 10-43 Zona 1, Guatemala
Telephone:            (502) 2412-0200
Website: www.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: 
http://medicamentos.mspas.gob.gt/index.php/legislacion-vigente/resoluciones-comieco

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: http://medicamentos.mspas.gob.gt/index.php/formularios/registro-e-inscripcion

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 Trade Mark 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 http://medicamentos.mspas.gob.gt/index.php/servicios/autorizacion-de-productos-farmaceuticos-y-afines/registros-sanitarios
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.
https://travel.state.gov/content/travel/en/legal/travel-legal-considerations/internl-judicial-asst/authentications-and-apostilles/apostille-requirements.html

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, www.unimarkcr.com
Details and registration forms for cosmetic products may be found in the following link:

http://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 http://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
drcpfa.jefatura@gmail.com
www.mspas.gob.gt

Prepared by our U.S. Embassies abroad. With its network of 108 offices across the United States and in more than 75 countries, the U.S. Commercial Service of the U.S. Department of Commerce utilizes its global presence and international marketing expertise to help U.S. companies sell their products and services worldwide. Locate the U.S. Commercial Service trade specialist in the U.S. nearest you by visiting http://export.gov/usoffices.