The National Administration of Drugs, Foods and Medical Technology (ANMAT) crosses a refunctionalization which is reflected in a series of measures announced recently.
Now, as far as he could tell Infobaea significant update has been introduced to the certification of laboratories abroad. This is a provision that updates the procedure for the issuance of Good Manufacturing Practices (GMP) Certificates destined for drug manufacturing plants located outside the country. This replaces the scheme in place since 2005 that required on-site inspections.
With this provision, the ANMAT may grant these certificates to foreign plants that are located in member countries of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), in MERCOSUR nations or that have a certification granted by a National Regulatory Authority (ARN) recognized by international reference organizations such as the Pan American Health Organization, without requiring your own audit abroad.
The initiative incorporates regulatory recognition mechanisms and reliance practices, allowing evaluations from other reliable health agencies to be considered to avoid duplication and accelerate procedures, although maintaining the power to carry out in-person or virtual inspections when the risk or type of product so requires.
According to what was reported from ANMAT, this process is essential for the registration of imported medicines in the Registry of Medicinal Specialties (REM)while ensuring compliance with the quality and safety standards required in the Argentine market.
In parallel to this regulatory modernization, as stated Infobaethe ANMAT has made progress in the review of a preventive measure. After the inhibition imposed on Beta Lab due to non-compliance with Good Manufacturing and Control Practices (GMPyC), published in the Official Gazette of the Argentine Republic (BORA) on October 1, the company presented a corrective and preventive action plan (CAPA), formalized through a Commitment Minute signed with the National Institute of Medicines (INAME). Both the firm and its technical management expressed their commitment to correct the deficiencies detected and guarantee compliance with current regulations.
He INAME evaluated that there are no current risks that justify maintaining total inhibition, as long as the correction plan continues to be followed. For this reason, the partial lifting of the measure was ordered: The general productive activities of the laboratory are enabled againincluding the La Rioja plant, the headquarters in the Autonomous City of Buenos Aires and the warehouse in Vicente López. Nevertheless, The suspension on the medicinal specialty is maintained Exotran (Mesalazine 500 mg), until ANMAT verifies effective compliance with the agreed corrective actions.
The laboratory must implement and demonstrate to the ANMAT the execution of the committed improvements. Once the health authority verifies compliance with these actions, the full restitution of productive activities may be considered, including the Exotran specialty.
When non-compliance with Good Manufacturing Practices or drug control is detected, the ANMAT applies preventive sanctions, such as the inhibition of productive activities, with the purpose of protecting public health and ensuring that medicines meet legal quality and safety standards. In fact, days ago, two laboratories They were disqualified due to irregularities in their production. In this way, they already add nine establishments inhibited since Augustafter the appointment of Gaston Moran as director of INAME.
Meanwhile, recently, the entry into force of the Provision 7939/25 published in the Official Gazette. As detailed Infobaethe regulations simplifies the establishment authorization process for cosmetic, personal hygiene productsoral hygiene of use dentaldisposable toiletries and household toiletries in Argentina.
The measure, which will come into force 60 administrative business days from publication in the Official Gazette, marks a change in regulatory managementand responds to the need to modernize and focus the role of the organization, as anticipated by the Minister of Health of the Nation, Mario Lugones, in an interview with Infobae.
The new provision eliminates bureaucratic procedures and digitizes the authorization procedure. Upon implementation, manufacturers and importers of the items covered will be able to present an electronic sworn declaration certifying compliance with current health requirements and Good Manufacturing Practices.
The system will automatically grant a file number, enabling the activity immediately and without expiration. “This way waiting times are significantly reduced to obtain the necessary authorization to operate, allowing activities to begin more quickly and efficiently,” details the ANMAT statement.
The regulations establish that the health authority will carry out subsequent verifications to ensure the compliance with Good Manufacturing Practicesmaintaining the protection of public health and the quality of the regulatory system. Digitization will also allow the creation of a comprehensive database updated in real time, which will contribute to the transparency and traceability of the process.
In an interview in July, the Minister of Health of the Nation, Mario Lugones, said to Infobae that these changes are part of a broader strategy to refunctionalize the ANMAT.
Lugones explained that The objective is for the agency to concentrate on the control of medicines, food and medical devices, leaving other areas, such as the cosmetics industry.under more decentralized regulation schemes.
“When you cover too much, in the end you lose sight of everything“, remarked the minister to this medium, who stressed the need to recover efficiency and public confidence in the organization. What Lugones’ management seeks is, on the one hand, for ANMAT to improve efficiency and regain public trust; and on the other, streamline functions to avoid overlapping powers.
This morning, the Minister of Deregulation and State Transformation, Federico Sturzenegger, highlighted in your account of Provision 7939/25 “generates a transcendental change in the functioning of the organization that puts it on par with similar agencies in the rest of the world.”
He explained that, until now, the process to authorize an establishment could take more than a year, with contradictory documentary requirements and requirements between different jurisdictions. “The provision changes this logic at its roots. It’s not that I ask for less responsibility: trust that you have everything that correspondsautomatically enables you with a digital affidavit, and inspects later,” he stated. In addition, he highlighted that the new system establishes ex post controls and sanctions for those who fail to complyallowing “those who comply can work. Those who do not, will be sanctioned.”
The impact of the Provision 7939/25 It extends to industry and public management. According to the statement of ANMATthe simplification of procedures will allow companies to start activities more quickly and efficiently, reducing errors and saving resources for both those regulated and the health authority.
From the perspective of health management, Lugones told Infobae that the reform of the ANMAT It is part of a broader process of modernization of the health systemwhich includes the creation of the National Agency for the Evaluation of Financing of Health Technologies (ANEFiTS) and updating key regulations, such as the regulations of the National Medical Residency System.
Provision No. 7939/25 indicates the guidelines for the authorization of establishments that carry out activities of import, processing, packaging, fractionation and/or conditioning of:
- Cosmetic, personal hygiene and perfume products
- Oral hygiene products for dental use
- Disposable hygiene products for external use and hygiene products for intravaginal use
- Household health products (with the exception of those establishments that carry out any productive activity related to Risk II-Group B products of Resolution No. 709/98).
Obligation to have a professional technical director
The regulations require that the aforementioned establishments (manufacturers, fractionators, importers of cosmetic products, personal hygiene, perfumes, oral hygiene for dental use, and other related products) must report and keep updated the information of the Technical Management/Co-Technical Management in the Affidavit (article 8). If there is a change in this position, the ANMAT must be notified within the stipulated period.
Affidavit mechanism
The new provision replaces the old requirement of prior authorization with a mechanism of sworn declaration. According to the provisions of articles 1 and 2, once the sworn statement has been submitted through the digital platform, the company is authorized to operate, but The ANMAT reserves the right to verify the accuracy and veracity of what is declared subsequently.. That is, the primary responsibility for compliance falls on the owner and the technical directors, and the health authority carries out the “a posteriori” inspection.
Supervision and sanctions
The provision establishes that The ANMAT may require supporting documentation for what is declared at any time and carry out inspections. (article 7). If false, inaccurate information, or essential omissions are detected in the sworn statement, the administrative and criminal sanctionsin accordance with Law No. 16,463, Law No. 18,284 and other related regulations (article 11 and reference to article 110 of the Administrative Procedures Regulation No. 1759/72). Criminal, civil or administrative liability could fall on the signatories or legal representatives.
