Regulatory Authority simplifies authorizations for new companies and products related to COVID-19
Amid the COVID-19 sanitary emergency, ANMAT -the Regulatory Authority in Argentina-, has established a new simplified mechanism that enables companies dedicated to the import and/or manufacture of critical medical supplies and diagnostic reagents for in vitro use, to expand their product categories and/or carry out the initial authorization of a company in a simplified manner.
Procedure for expanding production categories
Those companies that already have ANMAT’s authorization for importing and/or manufacturing medical products and wish to increase the safety risk class or add new product categories to their production lines, must request an “expansion of product category without structure modification”. Once the request is approved and proof of initiation of the expansion process is obtained, the product registration process may be initiated with ANMAT.
If adding a new product does not involve increasing the safety risk or expanding product categories (of the categories included in the current Good Manufacturing Practices (GMP) Certificate), the product registration process may be initiated with ANMAT directly.
Procedure for carrying out the initial authorization of a company
Those companies that wish to obtain an initial authorization can request it by submitting a set of relevant documents to ANMAT. Authorizations granted through this mechanism are valid until the last working day of December 2020.
Procedure for expanding production through authorized third parties
Those companies currently left without installed productive capacity may expand it through third parties. Said parties must be authorized by the National Institute of Medical Products and will own the product registries while also being held responsible for their manufacture and commercialization.
For assistance with any of the aforementioned procedures, please contact:
BERKEN IP
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