Two official documents released in 2026 address different regulatory issues: the cancellation of drug certificates in Argentina and the imposition of U.S. tariffs linked to forced labor. The contrast between the two allows us to specify what each source establishes, what it does not say, and what questions remain open.
What ANMAT Ordered Regarding 25 Certificates
Disposition 5866/2026, published on Wednesday, September 23 in the Official Gazette, canceled the authorizations to manufacture and market drugs of 15 companies. According to the text, 25 registration certificates in the Registry of Medicinal Specialties (REM) had expired and the renewal process had not been initiated. The document was signed by the agency’s national administrator, Luis Eduardo Fontana.
The secondary source—the La Nación article—indicates that the proceedings began following a review of non-renewed certificates conducted by the Directorate of Technical Information Management. During that review, it was detected that certain registrations had expired and that the corresponding renewals had not been requested.
The agency recalled that, under the Drug Law, authorization to manufacture and market a medicinal specialty is valid for five years from the date of the enabling certificate. Holders or representatives must request re-registration within 30 days prior to expiration. The regulations also provide for cancellation due to expiration of the term or due to modifications, alterations, or non-compliance with the conditions under which they were granted.
The list includes registrations whose expiration dates range from March 2019 to May 2025. It identifies certificate numbers, holder or representative companies, and validity dates, without detailing trade names or active ingredients. The companies affected are CSL Behring, Lafedar, Microsules Argentina, Aspen Argentina, Lavimar, Laboratorio Internacional Argentino, Savant Pharm, Laboratorios Monserrat y Eclair, Takeda Argentina, Megalabs Argentina, Eurofar, Monte Verde, Tecnonuclear, Terumo BCT Latin America, and Laboratorio Elea Phoenix.
The disposition ordered notification to the companies and informed them that they may file motions for reconsideration or appeal within 20 and 30 days, respectively, counted from notification. It also provides a 180-day period to initiate judicial action.
What the U.S. Decision Establishes
The Office of the United States Trade Representative (USTR) announced that Ambassador Jamieson Greer took final action, at the instruction of President Trump, under Section 301 of the Trade Act of 1974, imposing tariffs on 60 economies for failing to impose and effectively enforce a prohibition on the import of goods produced with forced labor.
According to the statement, the measure came after USTR investigations that included two rounds of public hearings, more than 2,100 public comments, and contacts with trading partners. On March 12, 2026, at the specific instruction of the President, the Trade Representative initiated 60 investigations. On April 28 and 29, 2026, public hearings were held. Pursuant to Section 303(a), the USTR held consultations with more than 45 governments of the investigated economies.
On June 2, 2026, the Trade Representative determined that the practices of the 60 investigated economies are unreasonable and burdensome to U.S. commerce, and therefore actionable under Section 301(b). As a result, it proposed responsive action and invited the public to submit written comments until July 6, 2026. The USTR received, reviewed, and analyzed more than 1,600 written comments. From July 7 to 9, 2026, public hearings were held with more than 100 witnesses.
The USTR also determined that product exemptions are appropriate for: (a) raw materials whose subjection to these tariffs could lead to the unavailability of domestic supply; (b) products that could cause disruptions across the economy; (c) products that cannot be grown or produced in sufficient quantities or at reasonable prices in the United States or obtained from other sources; (d) certain products from Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, the European Union, Guatemala, Indonesia, Jordan, Malaysia, Switzerland, Taiwan, or the United Kingdom that would encourage these economies to comply with commitments on prohibitions of forced labor imports or to enact and effectively enforce a prohibition; or (e) articles for which these tariffs might not contribute substantially to the elimination of the practices considered actionable.
What the Sources Do Not Say and What Questions Remain Open
The ANMAT disposition does not detail trade names or active ingredients of the drugs affected. Nor does it specify whether the companies initiated renewal procedures after the cancellation or whether the measure affects the availability of the products on the market. The La Nación article does not indicate whether any of the companies filed motions for reconsideration or appeal.
The USTR statement does not specify what concrete tariffs will be applied to each economy or the corresponding rates. It does not mention whether Argentina was included among the 60 investigated economies or detail the scope of the exemption for Argentine products. Nor does it specify the exact date of entry into force of the tariffs or the amount of comments received that were accepted or rejected.
Both sources are of a different nature: the ANMAT disposition is an official primary source published in the Official Gazette; the USTR statement is an official primary source disseminated by the agency. The La Nación article is a secondary source that comments on the disposition. Neither of the two primary sources confirms or contradicts the other: they address independent topics.
Value Module: What Each Document Establishes
| Document | Agency and Date | What It Establishes | What It Does Not Establish | Open Questions |
|---|---|---|---|---|
| Disposition 5866/2026 | ANMAT, 09/23/2026 | Cancels 25 REM certificates from 15 companies due to expiration without renewal; notifies and grants periods for appeals | Trade names, active ingredients, impact on availability, whether there were subsequent renewals | Did any company file appeals? Were the products restocked? |
| USTR Statement | USTR, July 2026 | Imposes tariffs on 60 economies under Section 301 for not prohibiting the import of goods with forced labor; details exemptions | Specific tariff rates, list of economies, effective date, whether Argentina was investigated | What tariffs apply to each economy? How is the Argentine exemption applied? |
No currency or unit conversions are made because the material does not include exchange rates or conversion factors. Figures are kept in their original units: certificates, companies, economies, comments, and days.
What Data to Follow
In the case of ANMAT, it is appropriate to follow the publication of any motions for reconsideration or appeal filed by the 15 companies and the possible re-registration of the canceled certificates. In the case of the USTR, it is advisable to monitor the publication of the notice in the Federal Register with the specific tariff rates per economy and the final list of exempt products, particularly those from Argentina.
Fuentes consultadas
El Sereno contrastó las fuentes enlazadas y añadió contexto, comparación o análisis documental. Las fuentes primarias están identificadas. La nota no se presenta como investigación de campo ni como entrevista propia, salvo indicación expresa.
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