How to register anesthetic ointment in Brazil?
Today on our blog the subject is about how to register anesthetic ointment at ANVISA, and you can check it out!
What is anesthetic ointment?
If the intention is to register anesthetic ointment at Anvisa, it is interesting to understand a little better about it. We are talking about a local anesthetic for topical use (it is applied in the place where you need the product), and it is commonly presented in the form of an ointment or gel. Its main function is stamped in the name itself: it is a product that anesthetizes the desired location by blocking nerve impulses from pain in the brain.
The anesthetic ointment acts by causing a momentary pain block, which occurs to facilitate procedures that may cause excessive pain to the individual, such as for intubation or endoscopy, or to get a tattoo, as well as it works to relieve the pain. pain that already exists in the mucous membranes and skin, in the case of hemorrhoids and fissures, and also burns. In dentistry, the use of anesthetic ointment is very common, serving to anesthetize the gums before applying liquid anesthesia by syringe.
What is the classification of anesthetic ointment at Anvisa in Brazil?
It is classified as a new drug: an anesthetic for topical (local) use, and because it carries the drug function, requires more detailed and precise documentation, which is exemplified below.
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What does it take to register anesthetic ointment at Anvisa in Brazil?
To register anesthetic ointment at Anvisa, as well as other medications, it is absolutely necessary that your company is perfectly regularized, that is, it needs, in the first place, the Operating License, which is issued by the local VISA, respecting all the rules established by DRC corresponding to the activity performed. It is the most careful phase of the whole process.
In addition, the company must acquire the Company Operation Authorization (AFE), which is issued by Anvisa, and lastly, before registration, it is necessary to obtain the Certificate of Good Manufacturing Practices (CBPF), since it is dealing with the category of drugs.
How to obtain the Operating License (LF) from the local VISA to register anesthetic ointment at Anvisa in Brazil?
The company that wants to register anesthetic ointment with Anvisa needs to obtain its license from the local Health Surveillance, through a rigorous inspection that is done in the establishment to identify if it is able to carry out the desired activity. This inspection is what determines whether the Operating License will be granted or not.
How to reach the Company Operation Authorization (AFE), to finally register anesthetic ointment at Anvisa in Brazil?
The last step to register anesthetic ointment at Anvisa takes place right there, in Brasília. In this process, Anvisa agents analyze all the documentation necessarily presented by the company, to ensure that no data or information is missing.
How to obtain the Certificate of Good Manufacturing Practices (CBPF) to register anesthetic ointment at Anvisa in Brazil?
We are talking about a medicine, which indicates that it will be essential for the company to obtain its Certificate of Good Manufacturing Practices (CBPF) to register anesthetic ointment at Anvisa.
For the CBPF to be acquired, the company must follow a series of rules and operational procedures that are established by Anvisa. The purpose is to achieve a high level of quality and safety at each stage of production, the choice and placement of the packaging, and the storage of the anesthetic ointment until it reaches the final consumer.
How to register anesthetic ointment at Anvisa quickly and economically?
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