by BERKEN IPLeaders League 2020 Ranking
Very proud to be ranked in @Leaders League 2020 in #iplitigation, #patent prosecution and #trademark prosecution in Argentina. Congratulations to Pedro Berkenwald, Alicia Alvarez Berkenwald, Ernesto Machicote, Federico Ulled and Barbara Porcario! #leadersleague
by BERKEN IPIAM Patent 1000: The World’s Leading Patent Professionals 2020
We are thrilled that BERKEN IP has been recognized in the 2020 IAM_magazine Patent 1000 ranking and that three of our partners are among the World’s Leading Patent Professionals #IAMPatent1000
by BERKEN IPRegulatory 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.
