If you don't know how to register autogenous vaccines at MAPA, check out the blog and clear all your doubts.
In times when vaccines have become the main topic of conversation circles, do you know how to register a vaccine at MAPA? What is an autogenous vaccine? Below are answers to these and other questions.
The autogenous vaccine is produced from microorganisms isolated and identified from sacrificed or sick animals, it allows precision immunizations and must go through an isolation step.
Its main objective is to cover possible variants or mutations of the agent, an example is influenza type A in swine (specifically H1N1, H1N2 and H1N3) that is a disease whose commercial vaccines cannot completely cover.
Some details must be taken into account, some of them even before you import, manufacture or commercialize any type of vaccine or start a regularization project, it is important that you pay attention to some details.
The issues of vaccine efficacy and safety must have their clinical studies and laboratory tests duly completed or, in case of clinical studies, at least in the final phase of the study.
It is also important that clinical studies and tests must be performed and prepared in accordance with the applications and claims of their products, in other words, the studies and tests required may vary radically when compared to products that have different applications or indications (even if the products resemble in their physical form or method of use).
The company that will manufacture these products must comply with the Good Manufacturing Practices at MAPA.
To register autogenous vaccines at MAPA, your company must comply with the regulatory agency's requirements. And before getting the product deferral, you need to obtain the Establishment Registration.
The Establishment Registration is the necessary regularization at the Ministry of Agriculture, Livestock and Supply for your company to carry out its activities.
Before registering a product, it is necessary that the Ministry of Agriculture, Livestock and Supply grant the Establishment Registration, proving that the company operates within the rules of its specific function.
The Quality System is a fundamental and mandatory tool whose main objective is to ensure the conformity, quality and safety of products. The Quality System is implemented in an exclusive way for each establishment, aiming at all the hygienic, sanitary and operational procedures elaborated, designed and implemented according to each company and activity to be performed, always aiming to care for the process and product.
Stone Okamont has a highly specialized team, duly trained to develop the most varied Quality Systems, in accordance with a wide range of global legislative variations.
Stone Okamont is also part of a small and select group of brazilian companies capable of carrying out “Quality System Harmonizations” in any country. Actions such as the elaboration of quality manuals based on Good Practices and, through corrective audits, are part of our company's day to day, in this way, registering autogenous vaccines at MAPA is easier and less bureaucratic for your company.
To register autogenous vaccines at MAPA, it is basically necessary to present tests, reports, studies and valid certificates of the final product to guarantee its efficacy and safety.
Don't know how to start the autogenous vaccines registration at MAPA? Talk to those who understand! Count on Stone Okamont, we have a "Dream Team" of trained professionals at your disposal to meet the needs of your company.
Don't waste any more time! Talk to one of our professionals and get all your doubts aswered about how to register autogenous vaccines at MAPA.