Anvisa, the National Health Surveillance Agency,has defined criteria and procedures for the manufacture and sale of hygiene products without prior authorization from the agency.
The companies of medicines, sanitizing and cosmetics regularized with Authorization of Operation (AFE), permit or health license issued by the competent health agency of the states, Federal District and municipalities will be allowed to manufacture and sell the products. In addition, companies must have all legal permissions for operation, including the manufacture and storage of flammable substances.
The measure is extraordinary and temporary and was motivated by the international public health emergency caused by the new coronavirus (Covid-19). The objective is to increase the offer of products on the market so that society has more access to protection items.
The rules are in the Resolution of the Collegiate Board (RDC) 350/2020 and came into force on Friday (20/3), however the rules are valid for six months.
Preparations extraordinarily and temporarily permitted for drug manufacturing companies:
70% ethyl alcohol (w / w);
glycerin ethyl alcohol 80%;
75% glycerinated isopropyl alcohol;
0.5% chlorhexidine diglyconate.
For cosmetics and sanitizing companies, the permission to manufacture and sell applies exclusively to 70% alcohol. Anvisa informs that the products’ validity period cannot exceed 180 days. It also clarifies that the new DRC suspends the effects of art. 2 of RDC 46/2002, which will allow the display and sale to the consumer of 70% liquid alcohol in one liter packaging.