by BERKEN IP

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:

Melisa San Juan
Attorney-at-Law
Regulatory Affairs & Compliance

Regulatory AffairsJune 8, 20200 comments 0 Likes

by BERKEN IP

Argentina Covid-19: new requirement relating to critical sanitary supplies

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

III. MEDICINE

Amoxicillin + clavulanic acid – Amoxicillin – Azithromycin – Budesonide aerosol – Cefalexine – Dexamethasone – Loratadine – Ibuprofen -Meprednisone – Paracetamol – Benzathine penicillin g – Salbutamol aerosol.

For more information and/or legal advice,
please contact:

Melisa San Juan
Attorney-at-Law
Regulatory Affairs & Compliance

Regulatory AffairsApril 3, 20200 comments 0 Likes