Registering hypertension medications can seem like a difficult and confusing process, mainly because it is a product that is related to people's health.
Hypertension is defined as high blood pressure, that is, when the values of maximum and minimum pressures are equal to or exceed 140/90 mmHg (or 14 by 9). Generally, it presents no symptoms, but should be treated, because in the long run it can cause serious health problems, such as: heart and vascular diseases.
The main cause of hypertension is obesity and sedentary lifestyle, followed by stress, smoking and alcoholism and high sodium (salt) intake. Doctors recommend how to prevent healthy diet, exercise and medications that can help lower blood pressure.
Because it is a highly recommended medicine, to register hypertension medications will be necessary to go through all the procedures and steps required by ANVISA. And following all requirements imposed by the National Health Surveillance Agency (ANVISA) your company and your product will act in safety conformities for end consumers.
Prior to the marketing of this product, you will need to obtain the following documents: Operating License, Operating Authorization, Certificate of Good Manufacturing Practices and Product Registration.
If you find it difficult to adapt your company or product under current laws seek advice. Stone Okamont is here to assist you in the drug registration process at Anvisa in a fast, safe and cost-effective manner.
See what are the steps required to obtain the register hypertension medications in ANVISA.
Step 1: Operating License
Before filing the application to register hypertension medications, the first step is to obtain the Operating License for your establishment. It is acquired from a survey conducted by VISA, in other words, the Local Sanitary Surveillance.
The Operating License is an approval document with the local Sanitary Surveillance, approving the technical and operational conditions of your establishment to carry out your activity and take you to the next step that is the Company Operating Authorization.
Step 2: Operating Authorization
The Operating Authorization (EGF) is a document issued by ANVISA, published in the Official Gazette (DOU). This document enables your company to carry out its activity for which it was petitioned at the Agency. Obtaining AFE means that the company operates in accordance with Brazilian legislation and is able to operate nationwide.
The AFE is necessary and indispensable for the next step that is the petitioning of the CBPF, that is, certificate of good manufacturing practices.
Step 3: Certificate of Good Manufacturing Practices
To register medicines for hypertension it is necessary to have the Certificate of Good Manufacturing Practices.
The CBPF is the document that attests compliance with the guidelines of the current legislation for the manufacture of a given product. It is one of the most improved parameters in the world, attesting that the establishment complies with Good Manufacturing Practices.
It is issued to prove that the company has been instructed and inspected during the manufacturing process. Its obtaining is necessary for the manufacture of medicines and, consequently, for its registration.
Step 4: Registration of medicines for hypertension
All companies offering products that may be harmful to health, such as medicines, pesticides, cosmetics, etc.; need to be up to date with all regularizations with ANVISA.
To understand the Product Registration in ANVISA, it is first necessary to understand that the risk classification is divided into categories ranging from I to IV, being I the lowest and IV the highest.
To obtain the registration of medicines for hypertension, the Good Manufacturing Practices is a requirement of ANVISA, since the product enters the risk classification XX.
The risk classification products III and IV must need the Certificate of Good Practices with ANVISA.
How can we help?
To register hypertension medications, Stone Okamont has regulatory experts to advise you at every step and ensure that the course of each process is as quickly as possible at the lowest cost.
The processes of regularization of company and product are very complicated and bureaucratic, without necessary knowledge in the area it is practically impossible to complete them without having to redo it several times, thus dispersing a lot of time and money.
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