Vitamin B12, also known as Cobalamin, is important for our body as it contains a number of essential functions. This medicine is a nutrient that has, among its functions, the production of red blood cells in the blood.
Currently the vitamin exists in tablet, drops, injectable and sublingual form.
There are some natural sources where this nutrient can be found. In general animal products contain large amounts of vitamin B12.
It is important to note that to register vitamin b12 in ANVISA it will be necessary to classify it as a medicine or as food. If your dosage for more than 60mg the product is already considered a remedy.
And, because it is a highly recommended medicine, it will be necessary to go through all the procedures and steps required by ANVISA. On average, the time to obtain product registration is 90 to 120 days, and in the case of drug registration, the average time is 90 to 180 days. But it is very important to remember that it is not possible to establish the exact time.
To register vitamin b12 in 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.
And of course, if you still have questions about the regulatory process click on the link below and talk to our consultants.
See what are the steps required to register vitamin B12 in ANVISA.
Step 1: Operating License
Before register vitamin b12 with ANVISA, the first step is to obtain the Operating License for your establishment.
The Operating License is the first document issued by the Health Surveillance (VISA), legalizing the operation of the activities of your company and respecting all the standards established by the DRC corresponding to the activity performed. It's the most judicious phase of the whole process.
In this process it is up to the institution to adapt its physical structure to receive the inspection of a visa supervisory agent to evaluate the technical and operational conditions of the site, so that its establishment can function and take you to the next step that is the Authorization of Company Operation.
Step 2: Company Operating Authorization to register vitamin b12 in ANVISA
The Company Operating Authorization (AFE) is one of the most important regulatory steps for the success of your business, and for this reason, it is necessary to count on specialized technical support.
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 Official Gazette (DOU), must be requested to start activities such as: manufacture, distribute, store, transport, import or export. This all occurs so that it is possible to register vitamin B12 in ANVISA.
In this phase there are petitions, verification of documents, collection of fees among others. Each type of category requires specific documentation, it is very important to look at the basic documents, because the lack of these 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 country.
Step 3: Good Manufacturing Practices to Register Vitamin B12 at ANVISA
The Certificate of Good Manufacturing Practices (CBPF), is the document that attests compliance with the guidelines of the legislation in force for the manufacture of a given product. It is issued to prove that the company has been instructed and inspected during the manufacturing process.
To register b12 vitamins in ANVISA, 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 with ANVISA.
Step 4: Registration vitamins b12 in ANVISA
The Product Registration is the document issued by ANVISA legalizing the commercialization of the same. 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: composition material, instructions for use, disposal instructions, and more are presented. In this way, the petitioning process must be respected, and the mandatory documentation must be attached and the petition to register vitamin b12 with ANVISAmust befiled.
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.
The Zero Bureaucracy method
We, at Stone Okamont have created the Zero Bureaucracy method, so that none of our clients suffer from the bureaucratic procedures required by regulatory bodies. This solution is customized, respecting and shaping the needs of each company.
The Zero Bureaucracy method is a set of facilities for the customer to focus on what they should focus on: their success. And Stone Okamont puts all its strength into what matters most: the path to success for its customers.
Contact Stone Okamont and learn how we can help you achieve your goals without wasting time with red tape!
