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
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:
Melisa San Juan Attorney-at-Law Regulatory Affairs & Compliance
Amid the COVID-19 sanitary emergency, the Ministry of Health and the Ministry of Productive Development issued a joint resolution by which companies producing, distributing and commercializing critical sanitary supplies that mitigate the spread of COVID-19 or treat it therapeutically or cure it, are summoned to increase the production, distribution and commercialization of these supplies to the maximum of their installed capacity.
It was also established that the companies dedicated to the commercialization and distribution of said supplies must grant purchasing priority to the sanitary entities determined by the Ministry of Health.
The manufacturing of critical sanitary supplies must be reported to ANMAT by submitting an application on the “Remote Procedures” (TAD) platform of the “Electronic Document Management” (GDE) system.
To access the instructions to carry out this procedure, click here.
LIST OF CRITICAL SANITARY SUPPLIES
I. EQUIPMENT
Adult Ventilator – Pediatric Transport Ventilator – Volumetric infusion pumps – Syringe infusion pumps – Hospital Bed – Intensive Care Bed – Cardiac arrest cart with defibrillator – Multiparametric monitor – Pulse oximeter (With display) – Pulse oximeter – Active humidifiers – Portable ultrasound – Manual resuscitator – Manual aspirators – Foot blood pressure monitor – Oxygen tubes Equipment for delivery of Extracorporeal Circulation with Membrane Oxygenation (ECMO) – Oxygen Concentrators -Thermometers with Digital Reader and Alert Beep
II. PROTECTION ELEMENTS
Triple Layer Surgical Chinstraps – Disposable gowns – Latex Examination Gloves – Protective goggles for medical use – Alcohol gel per 250/300 ml with dosing pump – Dacron swabs with transport tube – N95 mask chinstraps (homologable to FPP2) – Disinfectant detergent for surfaces and medical devices – Disinfectant detergent cleaner for floors, walls and medical devices – Repellent Spray – Mortuary bag
Excellent working breakfast about Coronavirus (COVID-19) in which the infectiologist Dr. Jorge Alejandro San Juan explained the what, how and why of the virus declared international emergency by WHO.
Emilio Berkenwald was invited once again by CEIPI in Strasbourg to lecture on Intellectual Property in Argentina #CEIPI #PropriétéIntellectuelle #IntellectualProperty
We are delighted to share that Managing Partner Alicia Alvarez Berkenwald has been listed in IAM’s brand new guide: “Global Leaders 2020” released on January 13, 2020. More info: https://www.iam-media.com/iam-global-leaders
Our Partner Lucía Scarpati presented the results of the joint INTA-ASIPI Study on the Economic Impact of Trademark Intensive Industries in Latin America and Caribbean Countries at INTA’s ISC Meeting in Austin, TX. Study deliverables at http://inta.org/impactstudies.
The AR PTO joins WIPO’s Digital Access Service for the exchange of priority documents of patents and utility models. As from October 01, 2019, the AR PTO will be an Accessing Office and as from March 02, 2020, a Depositing Office.