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Argentina's ANMAT issues new rules for GMP certificates of plants abroad
On 28 October 2025, Argentina published ANMAT Disposición 7998/2025 in its Boletín Oficial. The rule sets new guidelines for issuing GMP certificates to medicine plants located outside Argentina. It repeals Disposición 2123/2005 and took effect the next day.
By ZY Cleanroom · Updated · Sources at the end of the page
What the rule says
ANMAT, the national medicines regulator, signed the text on 27 October 2025. Annex I sorts foreign plants into four cases. In case I, the plant sends a valid GMP certificate from a PIC/S member authority, details of that inspection, and a list of its production lines and product types. Cases II to IV ask for more. They add a Site Master File, the plant's GMP inspection history and the status of open corrective actions.
ANMAT's own announcement says it can grant certificates to plants in PIC/S member countries, in MERCOSUR member countries, or with a certificate from a national authority that a reference body such as PAHO lists. The text cites "Good Reliance Practices".
Other points in the text
Source for the points below is the official text of Disposición 7998/2025. The national medicines institute, INAME, issues the certificate. It may order virtual evaluations or on-site inspections, based on a risk analysis. The risk analysis also sets how long a certificate stays valid.
A plant may apply to renew its certificate within the 60 business days before it expires. A new certificate is needed to add a biological product type, a production line or an active ingredient. Files already open follow the new rules.
What a facility owner should check next
If you export medicines to Argentina, find out which case applies to your site. Check that your Site Master File matches your rooms and lines.
Because a new line needs a new certificate, add the paperwork to your plan whenever you add a room or a line. Read the official text before you act. If you are planning a cleanroom, you can send ZY Cleanroom your room list.
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Sources
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