Epinephrine, also known as adrenaline, is a hormone released into the bloodstream that has the function of acting on the cardiovascular system and keeping the body in alert for strong emotions or stress situations such as fight, fugue, arousal or fear.
It’s a neurotransmitter medicine responsible for preparing the body for big feats. It can also be used as an antiasthmatic, vasopressor, cardiac stimulant and also in urgent situations.
The drug can control small skin bleeding and is also used as a local anesthetic. Usually, the remedy is most commonly used by people who are at high risk of having a severe allergic reaction.
To register epinephrine at ANVISA it will be necessary initially to obtain the company's regularization, this consists of the Operating License and Operating Authorization. After these steps are complete, you can begin the product registration process.
See what are the necessary steps to register epinephrine at ANVISA.
Step 1: Operating License
Before registering epinephrine at ANVISA, the first step is to obtain the Operating License for your establishment.
The Operating License the first document issued by the brazilian Health Surveillance (VISA), regularizing the activities operation of your company and respecting all the standards established by the RDC corresponding to the activity performed. It's the most judicious phase of the whole process.
In this process your company needs to adapt its physical structure to receive the inspection of a VISA’s supervisory agent to evaluate the place technical and operational conditions then your establishment can function and take you to the next step that is the Authorization of Company Operation.
The Operating License is necessary and indispensable for the next step that is the petition of the Company Operating Authorization.
Step 2: Company Operating Authorization
The Company Operating Authorization (AFE) is one of the most important regulatory steps for the success of your business, and for this reason it’s necessary to count with a specialized technical support. Without it, it will not be possible to register epinephrine at ANVISA.
The Company Operating Authorization, better known as "AFE", is a permission of ANVISA for the company to carry out its activities. The document, which will be published in the brazilian Official Gazette (DOU), must be requested to start activities such as: manufacture, distribute, store, transport, import or and export.
In this phase there are petitions, verification of documents, collection of fees among others. Each type of category requires specific documentation, it’s very important to look at the basic documents, because the lack of these can result in an instant rejection.
Obtaining the AFE means that the company operates in accordance with brazilian legislation and is able to operate throughout the country.
Step 3: Good Manufacturing Practices
The Certificate of Good Manufacturing Practices (CBPF), is the document that attests compliance with the brazilian legislation guidelines for the manufacture of a given product. It’s issued to prove that the company has been instructed and inspected during the manufacturing process.
To register epinephrine as its classification is risk class III, the Certificate of Good Practices is a requirement of ANVISA, which has one of the most improved parameters in the world, attesting that the establishment complies with Good Manufacturing Practices.
The risk classification products III and IV must need the Certificate of Good Practices at ANVISA.
Step 4: Register epinephrine at ANVISA
The Product Registration is the document issued by ANVISA regularizing its commercialization. From that moment on, the agency will review the petition in the most appropriate way, verifying the documentation presented to certify that the company is in accordance with current legislation and able to develop its activities.
In this final step, product information such as: material composition, instructions for use, disposal instructions, and more are presented. Thus, the petitioning process must be respected, mandatory documentation must be attached and the petition must register epinephrine at ANVISA.
Does it looks complicated? Talk to those who understand registration at ANVISA!
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