Do you know what homeopathic medicines are and how to regularize them? For these and other questions, we developed this blog. Read the full content and, if there is any difficulty in interpreting current legislation, contact us and make a quote.
What are homeopathic medicines?
According to current legislation, they are medicines developed with a raw material of mineral, vegetable, animal, or biological origin whose therapeutic indication is defined based on the fundamentals of Homeopathy and that are prepared following homeopathic pharmacotechnics.
What is the difference between homeopathy and traditional medicine?
In Homeopathy, the treatment is centered on the patient and not on the disease he presents at that moment. When ingested consistently, it stimulates the body to process self-healing, making the treatment cause less aggression than traditional treatment.
Do you intend to register/notify homeopathic medicines? See below for the necessary steps:
1) Obtaining the Operating License from the Health Surveillance (VISA) to register homeopathic medicines
This is the first step to be taken to regularize the company and to be able to register/notify homeopathic medicines. It is carried out with the Visa (Local Health Surveillance) of your municipality or state.
The Operating License is a document issued by the Health Surveillance Agency (VISA), which authorizes the operation of a company's activities when they meet the legal and regulatory requirements corresponding to the activity to be carried out.
At this stage, the establishment must adapt its structure following the prerequisites established by legislation for the activity to be carried out, to subsequently request the inspection of a VISA inspection agent, who will assess whether these conditions have been met and request the issuance of the Operating License.
The Operating License is indispensable for the next step: The application for the Company Operating Authorization.
2) Authorization to Operate a Company with the National Health Surveillance Agency (ANVISA) to register homeopathic medicines
The Company Operating Authorization (AFE) is granted by ANVISA (National Health Surveillance Agency) and is one of the most important regulatory steps for the success of your business, as without it will not be possible to register/notify homeopathic medicines.
This authorization consists of permission from ANVISA so that the company can carry out activities directly related to the CNAE specified in the CNPJ, which, in this case, would consist of the manufacture of medicines. This document must be requested to start any type of activity such as manufacturing, distributing, storing, transporting, importing, or exporting and, when granted, will be published in the Official Gazette of the Union (DOU),
To obtain this authorization, a petition process must be initiated, which includes verification of documents and payment of a fee. The documentation to be presented is directly related to the size of the company, so it is very important to pay attention to the base document, as it can result in instant rejection.
After obtaining the AFE, we can say that the company can operate following Brazilian legislation, that is, that it can operate throughout the national territory.
Before registering/notifying your homeopathic medicine, it is necessary to obtain the Good Manufacturing Practices Certificate.
3) Obtaining the Good Manufacturing Practices Certificate from the National Health Surveillance Agency (ANVISA) to register homeopathic medicines
To register the homeopathic medicine, it is necessary to obtain the Certificate of Good Manufacturing Practices (CBPF), which is the document that certifies compliance with the guidelines of the current legislation for the manufacture of a certain product. It is issued to prove that the company has been instructed and inspected during the manufacturing process.
After all these steps of Operating License, Operating Authorization, and Certification of Good Practices, we will be able to proceed with the registration/notification of homeopathic medicines.
4) Registration/Notification with the National Health Surveillance Agency (ANVISA) of the homeopathic medicine.
Homeopathic dynamized medicines can be registered or notified. Registration is required for drugs that present injectable pharmaceutical forms or any pharmaceutical form in a dilution lower than 1 (one) part for 10,000 (ten thousand); contain new active inputs; are subject to medical prescription, among others.
The Homeopathic Medicine Registration/Notification is a document issued by ANVISA legalizing the commercialization. To acquire this document, it is necessary for the agency to evaluate the administrative and technical-scientific documentation related to the quality, safety and efficacy of this drug, such as: composition, instructions for use, clinical studies, package insert, label, among others. If everything is within the parameters specified in legislation, the product will receive a registration/notification number.
Don't waste unnecessary time on your way to success. Contact Stone Okamont and facilitate the process of regularizing your company and product. Here you will find professionals specialized in this type of procedure. Count on us!
