by BERKEN IP

Regulatory AffairsApril 3, 20200 comments 0 Likes

Argentina Covid-19: Regulatory Affairs

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