ANMAT – Provision No. 7998/2025
Healthcare Law – Life Sciences Report | ANMAT – Provision No. 7998/2025
On October 28, 2025, ANMAT Provision No. 7998/2025 (the “Provision”) was published in the Official Gazette, through which the National Administration of Medicines, Food and Medical Devices (“ANMAT”) updates the procedure for the processing and issuance of certificates of compliance with Good Manufacturing Practices (GMP) of drug manufacturing plants located abroad, repealing ANMAT Provision No. 2123/2005.
The standard introduces a new evaluation scheme based on principles of cooperation and regulatory recognition (“Good Reliance Practices”), aligned with the international guidelines of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the standards of the Pan American Health Organization (PAHO).
Below, we highlight the most relevant aspects introduced by the Provision:
1. Purpose and regulatory scope: The objective of the Provision is to harmonize and modernize the system for the recognition of GMP certificates for plants located outside the country, applicable both to applications for registration in the Register of Medicinal Specialties (REM) and to post-registration modifications.
The National Institute of Medicines (INAME) will be the competent authority to evaluate the documentation, carry out inspections and issue GMP compliance certificates, in accordance with the guidelines approved as Annex I and the new model of official certificate approved as Annex II.
2. Main technical guidelines.
a) Evaluation by levels of regulatory recognition: The procedure distinguishes four scenarios according to the degree of international recognition of the health authority of the country where the plant is located:
– PIC/S Member Country: presentation of the current GMP certificate issued by the local authority.
– National Regulatory Authority (NRA) level III or higher: as assessed by PAHO or equivalent body.
– MERCOSUR member country: applying the criteria of regional harmonization.
– Other countries: will require extended documentation, including inspection history, corrective action compliance status, and validated Site Master File (SMF).
b) Documentation and deadlines: INAME will have 40 working days to evaluate the initial documentation and may request additional information or arrange virtual/face-to-face inspections according to risk analysis. The certificates will be issued with a validity period determined by said analysis, and their recertification may be requested up to 60 business days before expiration.
c) GMP Certificate Model: The new format (Annex II) establishes bilingual information (Spanish-English) on the requesting laboratory, manufacturer, inspected processes and date of inspection. It is clarified that the certificate reflects the state of the site at the time of the inspection, and its authenticity can be verified through the GEDO Viewer.
3. Incorporation of Good Practices of Regulatory Recognition
The Provision consolidates the adoption of regulatory reliance mechanisms, which allow ANMAT to base its decisions on verifications carried out by other high-reliability agencies. This practice seeks to optimize resources, avoid duplication of inspections and speed up access to safe, effective and quality medicines.
Reference bodies include the Pharmaceutical Inspection Co-operation Scheme (PIC/S), PAHO, and MERCOSUR inspectorates, promoting regulatory convergence and international cooperation in the field of health.
The Provision entered into force today.
Kind regards,