ANMAT Provision – No. 1741/2025
Health Department – Life Sciences Report | ANMAT Provision – No. 1741/2025
On April 22, 2025, Provision No. 2565/2025 (the “Provision”) was published in the Official Gazette, through which the National Administration of Medicines, Food and Medical Technology (the “ANMAT”) regulated the conditions for the market entry of medical devices concerning their expiration and/or expiry date, rendering ANMAT Provision No. 1655/99 ineffective.
Provision No. 1655/99 previously established that medical products with an expiration and/or expiry date of less than 1 (one) year could not be imported. However, according to the recitals of the Provision, the various sectors involved in the manufacture, import, and commercialization of medical products requested a review of this period, emphasizing the need to adapt inspection processes to technological advances in the field of human health. This is because the period then in force could generate fewer imports, limiting access to technologies that represent improvements in the quality of life of users.
Consequently, the Provision reduced the periods by half, establishing that imported medical products and their accessories cannot enter the country when their expiration date is less than 6 (six) months, except for those with a useful life approved by the National Institute of Medical Products of less than or equal to 6 (six) months, provided they are not expired at the time of entry into the country.
It should be noted that the Provision did not introduce changes regarding the regulation made by Provision No. 1655/99 of sterile medical products and potential adulterations of the expiration date on the original packaging.
Sincerely,