The wave of deregulation has also reached the National Administration of Drugs, Food, and Medical Technology (ANMAT). In Argentina, this agency holds no minor role: its role in analyzing and controlling products that directly impact the population's health makes it a key authority for ensuring commercial traceability and the safe consumption of goods destined for the community.
In this sense, the restrictions or prohibitions issued by ANMAT are intended to protect every inhabitant, not only nationally but also internationally, from products originating in the Argentine Republic. Thus, its work is also significant in regulating both imports and exports of goods such as medical equipment, medicines, and food.
Its areas of expertise include both medicines and medical technology products. Through the National Food Institute (INAL), it also regulates all food products, as well as all packaging that will come into contact with them, ensuring their safety and quality.
Deregulation process
(I.e.Medical products
This year, according to a series of provisions, the scope of the regulations that have always covered a wide range of operations was limited. So much so that in April of this year, Provision 2.857 (1) was published in the Official Gazette (BO), establishing that the administration will not intervene in the importation of medical products when their use is necessarily without a prescription and carried out by individuals. It also states that the use must be directly by the patient and user, and that this measure is not intended for profit, prohibiting those who wish to use this regime for commercial purposes or free distribution.
In May of this year, Provision 3.562 (2) was published. This time, the deregulation regarding personal importation targeted cosmetics, over-the-counter household sanitary products, oral hygiene products for dental use (including toothpaste and mouthwash), and disposable hygiene products for external use (disposable diapers for babies and adults, some feminine hygiene products, and disposable hygiene products). The regulation also specifically clarifies that the importation of the aforementioned products for commercial purposes and/or free distribution is prohibited.
It is worth noting that both regulations, or deregulations, expressly state that the user is solely responsible, assuming the consequences of their use and acquisition. The question is, how do we, as a State, discretionarily protect one citizen from another?
It turns out that if a quantity is imported for commercial purposes and someone purchases it through a store with taxes and other payments, having completed the necessary procedures to control it over the non-economic prohibition, we guarantee safety and reinforce personal care by protecting their health. However, if, on the other hand, we open up imports and allow each user to carry out their personal imports, consume that medication, use those products, and expose their bodies to products for which the necessary controls have not been carried out, then we would be faced with a dichotomy regarding the safeguards that should prevail in health. On the one hand, we ignore the protection of those who purchase directly, from those who obtain them under strict certification standards on the supermarket shelf.
In terms of facilitation, a different situation occurs with Provision 4.033 (3), which actually allows for improved control over samples imported specifically for testing, trials, and analysis. It is there that, by facilitating entry but still intervening through an import notice, deregulation is aligned with real control.
(I.e.Food and food contact
According to Provision 537/25 (4), the method in which interventions for food imports were carried out is facilitated, differentiating through Annex III origins and preferential agreements reached in order to be able, through the import notice, to document the release for consumption, leaving the rest of the origins in the hands of the import authorization according to the regulations and simplifying the records both for the registration of the establishment (RNE) and of the products (RNPA) through the Federal information system for the Management and control of food.
The aforementioned countries are AUSTRALIA, CANADA, SWITZERLAND, EUROPEAN UNION, UNITED STATES, NEW ZEALAND, STATE OF ISRAEL, JAPAN, UNITED KINGDOM and countries with which Economic Integration Treaties or Reciprocity Agreements govern in health and hygiene matters.
Regarding utensils intended to come into contact with food, it regulates the validity of processing a packaging and/or utensil authorization certificate, which, as was previously the case, requires the respective documents for specific shipment.
The real progress is evident when it comes to Annex III origins, since the import notice only requires stating that the product is authorized for public consumption in the domestic market of one of these countries, and must be accompanied by a marketing authorization or a free sale certificate or similar document.
It should be noted that the food import notice implies the entry of the merchandise with the right to use it. That is, once the sworn declaration is submitted, the merchandise will be admitted for subsequent circulation, marketing, and sale of the product involved.
Finally, this Provision is aligned with the European regulation EC 1.935/2.004 (5) for the registration of substances of components in contact with food, where the testing and certification protocol governs to guarantee the preservation of human health.
What happens to food under the simplified regime?
After the modification of shipments from postal service providers as private entities, 2 import categories were defined via Courier, differentiating between use for commercial purposes and personal use, which were exempt from taxes after Decree 1.065 (6) was published last year (2024).
Although the regulation establishes limitations on the number of annual shipments, weight and value, for personal shipments it is necessary to take into account the opening that was carried out according to the scope of the interventions.
On the ARCA micro-site (7), you can see the exemptions under this modality, which include:
- After intervention by the National Food Institute (INAL).
- Interventions by third-party agencies whose regulatory standards would have determined control in the domestic market after the goods have been released to the market.
- Merchandise Identification Regime (SIDIP).
- Economic restrictions and prohibitions.
- Following the intervention of the National Administration of Drugs, Food and Medical Technology (ANMAT), as mentioned above.
In Conclusion
Ultimately, in any case, the ultimate destination is a user, which raises an obvious contradiction: is comprehensive public health protection being guaranteed or only a partial safeguard? The inevitable question is whether, by relaxing controls based on entry regime, the State is differentiating between first- and second-class residents in terms of health protection. Should physical safety depend on the import channel or the scope of external controls?
It should not be forgotten that the protection of health is an obligation that the State must assume, since the right to health is included within the right to life, which is "the first natural right of the human person pre-existing to all positive legislation that, obviously, is recognized and guaranteed by the National Constitution" (8) to which must be added that in the Preamble of the National Constitution "there are already expressions referring to the general welfare, a preeminent objective in which, of course, the preservation of health must be computed with undisputed priority" (9).
Thus, while trade facilitation can be aligned with deregulation, when implementing measures aimed at greater openness in international trade—an objective we consider necessary—these measures must be implemented with the principle of responsibility. In cases such as health-related treatment, a proper balance must be struck between trade facilitation and the control that the State must assume.
- Provision 2857/2025 NATIONAL ADMINISTRATION OF MEDICINES, FOOD AND MEDICAL TECHNOLOGY 29-Apr-2025 (BO05.05.2025).
- Provision 3562/2025 NATIONAL ADMINISTRATION OF MEDICINES, FOOD AND MEDICAL TECHNOLOGY 22-May-2025 (BO28.05.2025).
- Provision 4033/2025 NATIONAL ADMINISTRATION OF MEDICINES, FOOD AND MEDICAL TECHNOLOGY
- Provision 537/2025 NATIONAL ADMINISTRATION OF MEDICINES, FOOD AND MEDICAL TECHNOLOGY 24-Jan-2025 (BO 30.01.2025).
Graduate in Foreign Trade (Universidad de la Marina Mercante), customs broker and customs transport agent. She works as a professor at the University of Belgrano and CAECE.
