Overview:
Brazil’s Health Authority has announced on August 14,2020 that it now requires companies that hold drug registrations must provide Anvisa daily information about the manufacture, import and distribution of anesthetics, sedatives, neuromuscular blockers and adjuvant agents, among other drugs used to maintain the lives of patients infected with the new coronavirus (Sars-CoV-2). The measure aims to provide Anvisa, as well as the Ministry of Health, updated information on the availability of drugs in the country to support decision making during the pandemic.
Mapping:
Every day, manufacturers and importers of drugs used for the intubation of patients requiring respiratory support will inform, everyday by midday, data on the amount of production and sale of these drugs completed the previous day, as well as the existing stocks of these products. The measure will make it possible to map the quantity of drugs available to serve the Brazilian population and will enable health managers to direct their efforts to allocate the products where they are needed.
How to Report to Anvisa:
1) Anvisa’s system (Datavisa) will send a notification via mailbox to the companies that hold the registration of drugs with active ingredients specified in the Call Notice No. 8/2020.
2) Companies shall fill out an electronic form daily with information regarding the manufacture, import and distribution of drugs.
3) The collection of information shall be for a period of 60 (sixty) consecutive days, extendable by decision of Anvisa motivated by the Ministry of Health.
The information provided will be confidential and will be shared only with the Secretariat of Specialized Health Care – SAES/MS and the Ministry of Health – MS
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations. To learn more, please contact us at info@globalregulatorypartners.com
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