6. Biological Specimen

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment.

The application gathers information about the import/export shipment which includes:

• Name and address of clinical sponsor/investigator authorized to conduct the study.
• Study protocol information (for studies taking place both in and outside of Argentina).
• Type of specimen(s).
• Information about the specimen(s)’ destination.
• Information about the specimen(s)’ origin.

Additionally, shipments of biologic specimens linked to studies approved in Argentina before 2013, require a certification letter from Argentina’s Drug Evaluation and Registration Directorate (DERM).

The certification letter must validate the need to continue importing/exporting biological specimens for protocols approved five years ago or more. This new rule aims to ensure that study protocols used to authorize the import/export of biological samples are still current and under proper supervision.

Companies in Argentina can apply for the DERM certification by using the new application “Request for proof of the validity of the authorization for the import/export of biological samples linked to clinical studies.”

6.2 Does local regulation require any separate consent for biological specimen collection, storage, and future research? If yes, please explain if there are any templates and/or links to be followed.

A) If biological samples are obtained as part of the research, informed consent shall include the following information:

1. The possible uses, direct or secondary, of biological samples obtained in the study
2. The fate of the biological samples at the end of the study (e.g. their destruction or storage for future use). In the latter case, it should be specified what the possible future uses would be and where, how, and for how long the samples will be stored, and that the participant has the right to decide on those future uses.
3. A statement that the samples or derived data will not be commercialized.
4. If a possible development of a commercial product from the biological samples is considered, if monetary or other benefits are expected to be offered to the participant. 

The transfer of any sample or biological material intended for scientific research between participant and researcher or between researchers or others should be free of charge, without prejudice to the possibility that the participant may receive financial remuneration for expenses or inconvenience suffered or that the recipient must cover the costs of sending and maintaining the samples or materials. 

B) Secondary use of biological samples

It may happen that researchers request to use biological samples that have been obtained as part of another investigation or samples that, at the time of collection, their purpose had not been defined. Secondary uses are subject to the conditions defined in the original consent; however, a Clinical Investigator may approve a secondary use provided that the original consent has specified the following:

1. Whether there will be or could be secondary use for those samples and, if so, what kind of studies could be conducted with those materials.
2. The conditions under which researchers will have to contact participants to request additional authorization for secondary or not yet defined use.
3. The plan, if any, to destroy unused samples or irreversibly dissociate them.
4. The right of participants to request the destruction or dissociation of samples.

6.3 Does the local authority require any specific documents for customs clearance?

There are specific documents for the customs/clearance of biological samples. The documents required are standard for the import/export of any type of goods as outlined below.

Products that are prohibited:

The Government of Argentina has prohibited the importation of the following products:

• Medical products containing nimesulide as an active ingredient (Disposition 4430/2009 ANMAT).
• Medicines and food containing olaquindox (Resolution 84/2007 SENASA).
• Additionally, ANMAT regulates and prohibits imports of certain toxic substances contained in products such as pharmaceutical products and cosmetics. Within ANMAT, the National Food Institute (INAL) regulates consumer-ready food products, health supplements, and both alcoholic and non-alcoholic beverages, except for wine.

Apart from the aforementioned, importing of medicinal products is regulated as follows:

Permission to Import

Argentina subjects imports to automatic or non-automatic licenses that are managed through the Comprehensive Import Monitoring System (SIMI) established in December 2015 by the Argentine Tax Agency (AFIP). The SIMI system requires the electronic submission of detailed information about goods to be imported into Argentina. Once the information is submitted, relevant Argentine government agencies review the application through a “Single Window System for Foreign Trade” (Ventanilla Única de Comercio Exterior, VUCE). The automatic import licensing requirements apply to approximately 85 percent of Argentina’s tariff schedule. Licenses are required for each import transaction and are reviewed by AFIP. The Central Bank requires AFIP approval to grant importers access to the foreign exchange market. An Argentine firm or individual who wishes to import must utilize the services of an Argentine customs broker to file the SIMI through the online customs system if they do not possess a customs brokerage license to handle their own imports.

Documentation Requirements and Restrictions

The Argentine government requires a certificate of origin and consularization for imports generally covering (but not limited to) consumer goods, textiles, apparel and footwear, printing machines, and machine tools. Consularization, or authentication by a consular office, is required for every country from which an integrated component is sourced. In order to receive the MFN tariff rate on a given product, a certificate of origin must be certified by an Argentine embassy or consulate or carry a “U.S. Chamber of Commerce” seal. Resolution 60/2018, passed in October 2018, eliminated the requirement for a certificate of origin for goods subject to antidumping or safeguard measures, instead requiring an online sworn declaration of non-preferential origin. The resolution also simplifies the process required to obtain a certificate of origin for most categories of products, except for textiles and footwear.

It is strongly advised that all exporters work with an Argentine customs broker or with a freight forwarder with an established relationship with a broker prior to shipping goods to Argentina.

Import/Export Documentation

Maritime Shipments

The following documents are required for all maritime shipments, regardless of value:

• Commercial invoice (original and three copies).
• Bill of lading (minimum of one copy for customs purposes).
• Packing list (not generally required for bulk commodities or for articles that are identical in kind, characteristics, composition, weight, etc.).
• Insurance certificate (if insurance coverage is purchased by the exporter).

Air Cargo Shipments

These documents are always required for air cargo shipments, regardless of value:

• Commercial invoice (original and three copies).
• Air waybill (number of copies depends on requirements of the importer and of the airline used).
• Packing list.

Freight forwarding and/or agents’ fees cannot be shown on airway bills; the fees must be prepaid. Argentina does not have a centralized platform for, and does not allow the use of, electronically produced airwaybills, which would accelerate customs processing and the growth of electronic commerce transactions.

Commercial Invoices

Commercial invoices must be presented in Spanish (one original and three copies) with the caption “Original Invoice.” Carbon copies, printed copies, or photocopied invoices will not be accepted in place of the original. In addition, a properly authorized member of the firm must provide an original signature in ink on each copy of the invoice presented (i.e., the original and three copies). The invoice should contain:

• Invoice number.
• Place and date of execution.
• Full name and address of the exporter.
• Full name and address of consignee.
• Full name and address of the agent/freight forwarder, (if any).
• Quantity, indicating measuring units invoiced.
• Name and description of goods (in Spanish).
• Unit price and total.
• Currency used in transaction.
• Terms of payment and delivery, using INCOTERMS.
• Origin and place/port of export of the merchandise.
• Means of transport (specifying via ocean, air, or parcel post)
• Port or place of entry into Argentina.

If the invoice is in English, the common practice is to show the Spanish translation just below the English text. The invoice must contain the following declaration in Spanish:

“DECLARO BAJO JURAMENTO QUE LOS PRECIOS CONSIGNADOS EN ESTA FACTURA COMERCIAL SON LOS REALMENTE PAGADOS O A PAGARSE, Y QUE NO EXISTE CONVENIO ALGUNO QUE PERMITA SU ALTERACION, Y QUE TODOS LOS DATOS REFERENTES A LA CALIDAD, CANTIDAD, VALOR, PRECIOS, ETC., Y DESCRIPCION DE LA MERCADERIA CONCUERDAN EN TODAS SUS PARTES CON LO DECLARADO EN LA CORRESPONDIENTE SHIPPER’S EXPORT DECLARATION.”

(Unofficial Translation: “I swear under oath that the prices on this commercial invoice are those actually paid or to be paid, and that no agreement exists that permits their modification, and all data pertaining to quality, quantity, value, prices, etc., and the description of the merchandise and its parts faithfully match what was declared in the corresponding Shipper’s Export Declaration.”)

A fax of the commercial invoice may be used as a working copy for Customs, but the original must be presented to complete entry. The commercial invoice must include payment terms, and the date on the commercial invoice must be prior to the bill of lading date.

Electronic documents with electronic signatures are acceptable if the certifying company has obtained eligibility by completing the licensing procedure. Electronic invoices are required for domestic sales or for Argentine exporters. Regarding importers, they need to present the commercial invoice that is issued by the overseas supplier. If the invoice is submitted electronically, the importer and customs broker should sign it as an affidavit. The invoice can be in English. A translation could be required by Customs authorities. Annex I of General Resolution 2793 at servicios.infoleg.gob.ar/infolegInternet/anexos/160000-164999/164919/texact.htm describes the supplementary documents required for import transactions.

Bill of Lading

The bill of lading should be issued (at minimum) in one negotiable copy; additional negotiable copies may be required by the importer, bank, steamship line, or other interested party (follow instructions from the importer or those given in the letter of credit or other contractual arrangement). Bills of lading must indicate the weight and volume of each package, as well as the total weight and volume of the shipment. All bills of lading must also show the amount of freight and a statement “Freight Paid” or “Freight Payable at Destination” as appropriate.

The bill of lading must show the following:

• Name of the ship
• Name of the ship’s captain
• Port of registry and registered tonnage (weight and volume)
• Name of the charter or the shipper
• Name of the consignee (unless it is “to the bearer” or “to order”)
• Number of packages, and specific description of the contents, the quantity, quality, and marks of the goods
• Port of loading and unloading, with a declaration of the port of call, if any
• Freight amount
• Place, method, and date of payment
• Date of preparation of the document and signature of the captain and of the shipper (signature of the shipping company and shipper should be signed manually; facsimile signatures are not acceptable)
• Container and seal number, and terms of shipment
• Invoice number suggested

Packing Lists

Packing lists are necessary for customs clearance in Argentina and must describe the content of each package. Where the contents of a parcel are the same as those in other parcels of the same lot, one description on the packing list covering the lot will be sufficient. The packing list preferably should be in Spanish. No packing list is necessary for goods imported in bulk, such as coal, petroleum, sand, etc., or for articles identical in kind, characteristics, composition, weight, etc. It is suggested that the packing list be included in every air shipment.

Consular authentication of the packing list may be required in certain instances. Check with the importer for exact requirements.

At least three copies of the packing list should be included as part of the shipping documents sent to the consignee or the agent thereof. The exact contents of each package should be clearly identified. This should include each item’s gross weight and net weight and each package’s marks and numbers. The required information must be consistent with all information shown on the commercial invoice.

Insurance Certificate

The U.S. exporter must request this document when purchasing insurance and should proceed according to the details provided by the importer. Marine insurance can be obtained from any insurance company.

Certificate of Origin

The certificate of origin is a document that may be required by Argentine Customs for consumer goods, textiles, footwear, apparel, printing machines and machine tools, organic chemicals, tires, bicycle parts, flat-rolled iron and steel, certain iron and steel tubes, air conditioning equipment, wood fibreboard, fabrics, toys, games, brooms, and brushes. This requirement by Argentine Customs falls under various circumstances:

Control of Preferential Origin

To claim preferential import duties when the country of origin has signed a trade agreement endorsing these preferences, as is the case of imports from member countries of MERCOSUR or ALADI (Latin American Integration Association). Argentine Customs authorities will require this document to grant preferential treatment at the importer’s request.

Control of Non-Preferential Origin

The Government of Argentina also requires a certificate of origin for certain products, such as textiles and footwear, regardless of their country of origin (Resolution MEOSP 39/96). This measure is in place to address import issues such as:

• Anti-dumping duties
• Countervailing measures
• Safeguard measures
• Import quotas
• Trade statistics

The certificate of origin requires the authorized signature of the local Chamber of Commerce Secretary in the United States, the seal of that organization, and the seal of legalization by the Argentine Consulate in the United States (located in Atlanta, Georgia, Chicago, Illinois, Houston, Texas, Los Angeles, California; Miami, Florida, New York, New York, and Washington, DC).  Note that if the product to be shipped contains component parts manufactured in another country, the U.S. company must obtain the signatures of the relevant chambers in those countries and have the document legalized by the Argentine Consulates in those countries.

https://www.trade.gov/country-commercial-guides/argentina-prohibited-and-restricted-imports