Stone has prepared a blog that will help you in the process of registering a contact lens solution.
The contact lens solution is used for better conservation, clear, disinfect, remove proteins, preserve, lighten and lubricate any type of lens.
To register the contact lens solution at ANVISA, it is first necessary to regularize the company that requests the registration. This regularization consists of obtaining the Operating License, followed by obtaining the Company Operating Authorization (AFE). After these steps, the regularization of the product can begin.
The Operating License is a document issued by the Health Surveillance Agency (VISA), which authorizes the operation of a company's activities, when it is verified that it complies with legal and regulatory requirements corresponding to the activity to be carried out.
At this stage, the establishment must adapt its structure in accordance with the prerequisites established by legislation for the activity to be carried out, in order to subsequently request the inspection of a VISA (Local Sanitary Surveillance) inspection agent, who will evaluate 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 Operating Authorization (AFE).
The Company Operating Authorization (AFE) is one of the most important regulatory steps for the success of your company, without this authorization it will not be possible to register the contact lens solution at ANVISA (National Health Surveillance Agency).
This authorization consists of a permission from ANVISA so that the company can carry out activities related to medicines or pharmaceutical ingredients. The document, which will be published in the Official Gazette (DOU), must be requested to start activities such as: manufacturing, distributing, storing, transporting, importing or exporting.
At this stage, a petition process must be initiated, which includes document verification, payment of fees, among others. Each 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 (or summary rejection).
Obtaining the AFE means that the company operates in accordance with brazilian legislation, that is, the company will be able to operate throughout the national territory.
The Contact Lens Solution 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 quality, safety and effectiveness. After submitting this documentation, in the form of a technical petition, the Agency will analyze and certify that the company is in compliance with current legislation and always focusing on the pillars of efficacy and safety, always having as a premise tests, reports, studies, applicable certifications and of course the verification and compilation of the technical dossier gathering all these documents.
Stone Okamont makes this whole process much easier. Talk to those who understand about registration at ANVISA!
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