How to register analgesics at ANVISA

How to register analgesics at ANVISA

Analgesics are medications that are useful to reduce or stop pain associated with injuries, illnesses or surgeries.


There are 3 classes of analgesics:


  1. Common ones like dipyrone and acetaminophen;
  2. Anti-inflammatory such as aspirin, ibuprofen and diclofenac; and;
  3. Opioids such as morphine, codeine and tramadol.


In order to consolidate the registration of this type of product at ANVISA, we must go a long way, starting with the regularization of the institution/company that will request the registration. The first step in this regularization is obtaining the Operating License from the Local Sanitary Surveillance (VISA). After this regularization has been carried out, the next step is to acquire the Company Operation Authorization (AFE) from ANVISA. As it is a manufacturing process and a class III product, the requesting company must still obtain a Certification of Good Manufacturing Practices (CBPF). Finally, after obtaining these two licenses and the CBPF, you can start the product regularization.


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Step 1. Operating License (VISA)


The Operating License is a document issued by the Local Sanitary Surveillance (VISA), which authorizes the operation of a company's activities, when verified its compliance with legal and regulatory requirements corresponding to the activity that will be performed.


At this stage, 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 verify if these conditions have been met and request the issuance of the Operating License.


The Operating License is necessary and indispensable for the next step, which is the application for the Company Operation Authorization.


Step 2. Company Operation Authorization (ANVISA)


The Company Operation Authorization (AFE) is granted by ANVISA (National Health Surveillance Agency) and is one of the most important regulatory steps to your company's success, as without it, it will not be possible to register your product/analgesic.


This authorization consists of a permission from ANVISA to the company to carry out activities directly related to the activity / CNAE specified in the CNPJ, which, in this case, consists of the manufacture of medicines. The granted document, which will be published in the brazilian Federal Official Gazette (DOU), must be requested to start any type of activity 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 can result in instant rejection.

Obtaining the AFE means that the company operates in accordance with brazilian legislation, that is, it is able to operate throughout the national territory.


Step 3. Good manufacturing practices certification (ANVISA)


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


Step 4. Analgesic Registry (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 a petition form, 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 ones, other information about the product will also be presented, such as: composition, instructions for use, clinical studies, leaflet, label, among others. Therefore, to register analgesics at ANVISA, all these steps must be met.


Don't waste unnecessary time on your way to success. Contact Stone Okamont and facilitate the regularization process of your company and product. Here you will find professionals specialized in this type of procedure. Count on us!!!!

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