ANMAT Establishes New Requirements for the Licensing of Regulated Establishments and the Appointment of Technical Directors – Provision – No. 4550/2026
Healthcare & Life Sciences Department Report | ANMAT Establishes New Requirements for the Licensing of Regulated Establishments and the Appointment of Technical Directors – Provision – No. 4550/2026.
Dear all,
On July 22, 2026, Provision No. 4550/2026 (the “Provision”) was published in the Official Gazette, through which the National Administration of Medicines, Food and Medical Devices (“ANMAT”) established the obligation to submit criminal record certificates and a sworn statement evidencing the lawful origin of funds in connection with the licensing procedures for establishments regulated under Law No. 16,463 and the appointment of technical directors.
The measure is grounded in the need to strengthen controls over the legal suitability of those involved in activities within the pharmaceutical sector, as well as to ensure traceability of the origin of funds invested in licensed establishments. According to the recitals of the Provision, the identification of Ultimate Beneficial Owners of legal structures —pursuant to the Anti-Money Laundering Law (Law No. 25,246) and FIU (“Financial Information Unit”) Resolution No. 112/2021— helps prevent the use of legal vehicles to conceal the true parties interested in the regulated activity and strengthens the integrity, transparency and reliability of the regulatory system for medicines. These requirements are aligned with international standards on the prevention of money laundering and terrorist financing.
In this regard, the Provision establishes the following requirements:
1-Criminal record certificate: the Provision requires the submission of a certificate issued by the National Registry of Recidivism in: (a) the licensing procedures for establishments engaged in the import, export, production, manufacturing, fractionation, commercialization or storage of medicines and products regulated by Law No. 16,463; and (b) the appointments and acknowledgment of appointment of Technical Directors and Co-Directors.
2-Obligated parties: the certificate must be submitted by: (a) Technical Directors and Co-Directors; (b) members of the management bodies of the intervening legal entities; and (c) the Ultimate Beneficial Owners holding at least 10% of the capital stock or voting rights, as provided by Law No. 25,246 and FIU Resolution No. 112/2021.
3-Disqualifying offenses: the certificate must evidence the absence of convictions for willful criminal offenses, offenses related to public health, drug trafficking or diversion of narcotics, economic crimes against public administration, or crimes against public faith.
4-Sworn statement on origin of funds: Additionally, in the licensing procedures for establishments, a sworn statement (affidavit) evidencing the lawful origin of funds allocated to the investment for the installation, modification and/or expansion of the establishment must be submitted. To that end, the form attached as Annex I must be executed by the owner, legal representative or attorney-in-fact, declaring under oath that the funds originate from lawful activities and that the firm has supporting documentation.
5-Consequences of non-compliance: non-compliance with these obligations prevents the approval of the applications, without prejudice to the sanctions set forth in Law No. 16,463 (warnings, fines, closure of the establishment, suspension or disqualification) and other applicable regulations.
The Provision entered into force on July 22, 2026, the date of its publication in the Official Gazette.
Sincerely,