Combined products in Brazil – brief comments on Anvisa’s (Brazilian National Health Surveillance Agency) current understanding
The new generations of products are the result of the increasing combination of different technologies, leading to a crossing of borders between the different categories of products subject to sanitary surveillance. Such products fall into certain categories due to their technical characteristics, which include, among others, possible therapeutic claims, main intended use, chemical composition, place of application and mechanism of action. The framework of the products meets what is provided for in the health legislation and can fit into the following categories before the Agency: medicines, medical devices, food – including food supplements -, cosmetics, hygiene products and perfumes, sanitizers, smoke products – derived or not from tobacco –, advanced therapy products, pesticides and the like.
Among the new generations of products, the combined product stands out, which, as defined in Technical Note No. 1/2021/SEI/COMEP/ANVISA, “is a product that comprises two or more components that are regulated as products subject to sanitary surveillance, such as medicine/medical device, vaccine/medical device, which combine physically, chemically or otherwise, produced as a single entity”.
In Brazil, unlike other jurisdictions, there is still no specific legislation dealing with the registration and regularization of combined products (of different categories). Anvisa’s guidance, when it comes to this type of product, is in the sense that it is necessary to evaluate the specific case to identify how the registration should be and in which area the products must be regularized. In other words, the Agency establishes that, in case of doubts regarding the classification of a combined product, it must follow the same flow of analysis defined for the so-called borderline products, given the absence of specific regulations in this regard. According to Anvisa’s definition, borderline products are products that are difficult to distinguish such as medicine, medical device, cosmetic, food, among other categories, due to their technical characteristics that include composition, place of application/use, presentation and mechanism of action. These products are called borderline products until their classification is decided by Anvisa, resulting in the designation of a specific regulatory pathway.
However, it is important to emphasize that combined products are not classified as borderline products, so that many doubts may arise regarding the correct regulatory classification of these products.
Anvisa advises that the company, which seeks to identify how the registration should be and in which area the combined products must be regularized, read the technical criteria for framing borderline products, established in Technical Note No. 1/2021/SEI/COMEP/ANVISA, and forward the product classification form or subjection or not to sanitary regularization through electronic petition in the Electronic Information System – External User.
In this petition, based on the completion and submission of the electronic form of product classification or subjection or not to sanitary regularization and the presentation of technical and scientific evidence in order to support the analysis of the claim, the company must indicate:
- The option to classify the product in one of the categories provided for in the sanitary surveillance regulation, by analyzing whether or not the product is subject to sanitary regularization by Anvisa or both;
- The data of the company responsible for the product in Brazil;
- The characteristics of the product to be analyzed;
- Information on the regularization of the product in other countries;
- Information on similar products regulated in Brazil; and
- Complementary information about the demand (this is the scientific evidence about the product object of the petition).
The application for registration of a combined product may be forwarded by the technical area of the Agency that initially received it for analysis by the Committee for the Qualification of Products Subject to Sanitary Surveillance (COMEP) in cases in which it is not entirely clear, according to the legislation, which category that fits and when different understandings can be considered when framing the combined product. Therefore, in this case, the product will follow the workflow defined for the classification of borderline products, which must be registered according to the recognized categories. The workflow is concluded with the final decision of Anvisa’s Collegiate Board (after analysis by the technical area and subsequent evaluation and manifestation of COMEP) and the decision is communicated by the technical area for which the product is intended to the company responsible for the product, which also receives any guidance in relation to the measures to be taken.
If you would like to be informed of further developments in this matter and/or need any assistance or clarification, please do not hesitate to contact us at email: firstname.lastname@example.org.
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