In this content, we will discuss what it takes to register an anticoccidial in the MAPA and briefly talk about the regulatory steps to obtain the registration of your product.
Anticoccidial additives are products added to animal feed in order to prevent or treat coccidiosis.
The registration of the anticoccidial will be granted after compliance with the Regulation approved by Decree 5053, of April 22, 2004.
But before registering the anticoccidial register in MAPA, there are other steps to be taken, see below.
Do I need to regularize my company to register anticoccidial in MAPA?
The company's regularization is essential to register anticoccidial in the MAPA. It is requested according to the activity carried out by your company. Obtaining the Register of Establishment, your company is able to manufacture, store and/or distribute.
Registration of Establishment
Before obtaining the approval of the anticoccidial, it will be necessary to obtain the Registration of Establishment, the company needs to be regulated with the MAPA regardless of its activity if you are importing, manufacturing or buying from someone who already has regulation and if in any way you carry out a action, it is necessary to regulate your company.
Implementation of the Quality System to register anticoccidials in the MAPA.
The system of good practices is a tool to ensure compliance, quality and safety of products. The quality system is implemented exclusively for each establishment, aiming at all hygienic, sanitary and operational procedures.
Stone Okamont has a competent team to develop the quality system, prepare the quality manual based on good practices and, through implementation and correction audits, indicate what should be improved throughout the quality system through reports.
What do I need to register anticoccidial in MAPA?
In order to register an anticoccidial in MAPA, the safety and efficacy of the product must be ensured through reports, tests and analyzes, as well as ensuring that there has been no contamination and/or addition of prohibited products. In addition, the entire regularization process must be presented in the form of a technical dossier and evaluated by the competent technical authority designated by MAPA.
According to Normative Instruction No. 54, of December 17, 2018, all clinical studies must be carried out in accordance with good veterinary clinical practices.
Sound complicated? Talk to Stone Okamont
If you are looking to register an anticoccidial in the MAPA, contact Stone Okamont, our company has excellent professionals willing to carry out all the intermediation between you and the regulatory agency in question.
Fill out the form below, talk to one of our professionals and get all your questions answered about how to register an anticoccidial in MAPA.
