How to register epinephrine at ANVISA?

How to register epinephrine at ANVISA?

Epinephrine, also known as adrenaline, is a neurotransmitter hormone released into the bloodstream that has the function of acting on the cardiovascular system and keeping the body in alert for emergency situations, but it can also be used as an antiasthmatic, vasopressor, cardiac stimulant.

To register epinephrine at ANVISA it will be initially necessary that the company obtain its regularization. This consists of obtaining the Operating License (LF) and Company Operating Authorization (AFE). After these steps, the product registration process can be initiated.

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Step 1: Operating License (granted by the local or state brazilian Health Surveillance)

The Operating License is the first document issued by the Health Surveillance (VISA), regularizing the activities operation of a company if it respects all the standards and criteria corresponding to the activity that will be performed.

At this step, the establishment must adapt its structure according to the prerequisites established by legislation for the activity to be performed, to subsequently request the inspection of a VISA’s inspection agent, who will evaluate if these conditions have been met and request the issuance of the Operating License.

The Operating License is necessary and essential for the next step, which is the request for the Company's Operating Authorization.

Step 2: Company Operation Authorization (granted by the National Health Surveillance Agency)

The Business Operating Permit (AFE) is one of the most important regulatory steps for the success of your business. Without it, it will not be possible to register epinephrine at the brazilian National Health Surveillance Agency (ANVISA).

This authorization consists of a permission from ANVISA for the company to carry out activities related to drugs or pharmaceutical inputs. The document, which will be published in the brazilian Federal Official Gazette (DOU), must be requested to start activities such as: manufacturing, distributing, storing, transporting, importing or exporting.

At this stage, a petition process must be initiated, which includes the verification of documents, collection of fees, among others. Each type of category requires specific documentation and it is very important to pay attention to the base documents, as the lack of any of these documents can result in instant rejection.

Obtaining the AFE means that the company operates in accordance with Brazilian legislation and is able to operate throughout the national territory.

Step 3: Obtaining Good Manufacturing Practices Certification (Granted by the National Health Surveillance Agency)

The Certificate of Good Manufacturing Practices (CBPF) is the document that certifies compliance with current legislation guidelines for the manufacture of a particular product. It is issued to prove that the company was instructed and inspected during the manufacturing process.

To register epinephrine at ANVISA, which is classified as Risk Class III, it is necessary to obtain this certification, as products classified as Risk III and IV necessarily need the Good Manufacturing Practices Certificate issued by ANVISA.

Step 4: Epinephrine registration at ANVISA

The Medicine Registration is a document issued by ANVISA, legalizing its commercialization. In order to acquire the registration, it is necessary for the Agency to evaluate the administrative and technical-scientific documentation related to the quality, safety and efficacy of this drug. After submitting this documentation, in the form of a petition, the Agency will analyze and certify that the company complies with current legislation and is able to carry out its activities.

In this final step, in addition to the concessions that make up the previous steps, other information about the product must be presented to be able to register epinephrine at ANVISA, such as: composition, instructions for use, clinical studies, leaflet and label.

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