1 – I have products registered in the name of my distributor or even in the name of acompany that hosts registers. Is it possible to make another registration of these sameproducts, i.e., having the same product registered twice by different companies(registration holders)?BRISA ADVISORS: Yes, it is possible to have the same product registered by more thanone registration holder at ANVISA. But also, it is possible to transfer ownership of classIII and IV products when the current registration holder agrees with this procedure. 2 – In which cases can I request the transfer of ownership of registers?BRISA ADVISORS: In corporate and commercial operations between companies thatcarry out activities subject to sanitary control – ANVISA, which implies the change ofownership of product registration, since the conditions and technical-sanitarycharacteristics of companies, products and clinical trials are kept. 3 – Which are the definitions adopted by RDC No. 102/2016?BRISA ADVISORS:I – technical and health characteristics: regular conditions of the product, company, orclinical trial at ANVISA, immediately before the corporate or commercial operation;II spin-off: corporate operation in which a legal entity transfers parts of its property toone or more legal entities established for this purpose, or already existent, extinguishingthe demerged company if all its assets are transferred, or dividing the capital if thetransfer is partial;III – succeeded company: legal entity that transfers to the successor company the rightsand obligations on the product object of registration transfer, the establishment, or theresponsibility for clinical testing as a result of corporate or commercial operations;IV – successor company: legal entity that now has the rights and obligations on theproduct object of registration transfer, the establishment, or the responsibility forclinical testing as a result of corporate or commercial operations;V – merger: corporate operation in which two or more legal entities are merged to createa third one, succeeding them in all rights and obligations;VI – incorporation: corporate operation in which one or more legal entities are absorbedby another one, succeeding them in all rights and obligations;VII – commercial operation: operation between companies resulting in the sale of assetsor group of assets, without the occurrence of any corporate transaction between thecompanies involved;VIII – corporate transaction: corporate action involving the merger, spin-off orincorporation under Law no. 10,406, of January 10th, 2002, and, in a subsidiary manner,Law no. 6,404, of December 15th, 1976;IX – Mercosur representative: company located in the Receiving State Party [EstadoParte Receptor (EPR) in Portuguese], which is contracted to represent a registrationholder in the Producing State Party [Estado Parte Produtor (EPP) in Portuguese] andassumes the legal and technical responsibility in the EPR;X – global transfer of responsibility for clinical testing: modification characterized by thechange of the applicant of clinical trial dossiers, notification of clinical testing, dossiersof clinical development of drugs (DDCM), dossiers of clinical investigation of medicaldevices (DICD), expanded access programs, compassionate use programs and supply ofpost-study drug, in cases of corporate or commercial operations, without any change oftechnical and health characteristics contained in the Specific Special Communiqué[Comunicado Especial Específico (CEE) in Portuguese], Document for the Import ofProduct under Investigation or Special Communiqué), object of change;XI – transfer of registration holder: modification characterized by the change of theregistration holder of products subject to health surveillance, in case of corporate orcommercial operations, without any change of technical and health characteristics inthe registration of product object of transfer. 4 – In cases of commercial or corporate operations carried out abroad, does this RDCalso apply?BRISA ADVISORS: Only in cases where these operations carried out abroad imply theneed to update data at ANVISA by the registration holder in Brazil, such as updating theCBPF or in case of alteration in the registers of existing products to communicate withthe new manufacturer. 5 – Can the Certificate of Good Manufacturing Practices (CBPF) and the Company’sOperating Permit (AFE) be transferred along with the registration of the product?BRISA ADVISORS: In fact, already published BPF certificates can have their updatedregistration data for the new applicant, provided that the previously examinedtechnical-health characteristics, whenever the corporate or commercial operation ofregistrations of already deferred products. The validity of the certificate does notchange, it will remain the same as the initial order made by the succeeded company.For initial requests of CBPF that are still awaiting or with analysis not yet completed, itwill not be possible to update the registration data. The succeeded company mustpromote the addition of the petition to update the documentation, with a view toinstructing and continuing the analysis of the petition in progress.The AFE may be updated through a petition for amendment, cancellation, or concession,whenever there is a corporate transaction that will result in a new person legal entity,or when there is already a legal entity not regularized with the surveillance health,regularization will always be through an initial grant request for AFE.It is important to point out that the Certificate of Good Manufacturing Practices aregranted for each establishment, by production line. When the succeeded company’soriginal certificate must be maintained, the successor company must request on itsbehalf a new certificate for the line involved. This situation may lead to a new sanitaryinspection.6 – Which are the deadlines that must be watched?BRISA ADVISORS:a) 180 days: For requests for transfer of ownership and cancellation of registration ofhealth products, which must be concurrently filed with ANVISA, respectively by thesuccessor and succeeded company, the period is up to 180 (one hundred and eighty)days from the date of filing of the corporate act registered with the board of trade or ofthe celebration of the contractual instrument of the commercial operation, or, in thecase of a representative Mercosur, will be counted from the date on which theinterruption of the contractual relationship between the parties contained in theDeclaration (Annex I of the RDC 102/2016) is formalized.b) 180 days: Companies will have a maximum of one-hundred and eighty (180) days tosell out the remaining stock of finished products after the entry into force of Resolutionsof cancellation and transfer of registration.c) 90 days: Resolutions of cancellation and transfer of ownership registration of productssubject to health surveillance addressed in this resolution shall come into force ninety(90) days after its publication and

In the current context of Brazilian public health, the effective detection and monitoring of notifiable diseases such as Dengue, HIV, COVID-19, Chikungunya, Zika Virus, monkeypox, and Leptospirosis represent a significant challenge and a unique opportunity.  The introduction of advanced in vitro diagnostic (IVD) devices into the Brazilian market is not only an urgent need but also an opening for commercial expansion. This text aims to demystify the regulatory landscape and highlight the strategic importance of deploying these devices in Brazil, pointing out to the CEOs of manufacturing companies the latent potential for development and leadership in the sector.  Overview of Notifiable Diseases and Their Impact on the Health System:  Brazil faces a complex dynamic of infectious diseases, with significant seasonal and geographical variations. The effectiveness of controlling these diseases necessarily passes through early and accurate diagnosis, which places IVD devices as crucial tools in public health management. The rapid identification of pathogens allows for targeted interventions and the implementation of control measures, reducing transmission and the impact on health resources.  IVD devices encompass a wide range of technologies, including rapid diagnostic kits, reagents, and automated platforms, capable of specifically detecting infection markers of various natures (viral, bacterial, parasitic). The introduction of molecular diagnostic platforms, for example, offers unprecedented sensitivity and specificity, essential for the diagnosis of infections like COVID-19 and Zika Virus, where the viral load and the presence of antibodies are critical indicators of the disease phase and the individual’s immune response.  ANVISA imposes strict criteria for the approval of IVD devices, ensuring their safety, efficacy, and quality. The risk classification of these devices indicates the degree of regulatory control needed. Although the regulatory process may seem intricate, it presents an opportunity for companies aiming to establish benchmarks of excellence and safety in innovative products. Navigating the regulation requires in-depth knowledge of the norms and constant dialogue with ANVISA, facilitating approval and market introduction. It is important to highlight Ordinance 204 of 2016, which establishes notifiable diseases, and according to RDC 830/2023, diagnostic products for these diseases are generally classified in classes III or IV, requiring Good Manufacturing Practice Certification for product registration.  The IVD device market in Brazil is vast, offering significant opportunities for innovative companies. With a population of over 210 million, the demand for advanced diagnostic solutions is growing, especially for notifiable diseases. Moreover, the ability to offer products adapted to Brazil’s epidemiological and infrastructural specificities can differentiate companies in the market, establishing them as leaders in innovation and strategic partnerships with the public and private sectors.  The integration of innovative IVD devices into the Brazilian health system is more than a necessity; it is a strategic opportunity for companies looking to lead the next wave of innovation in public health. Through a collaborative approach with regulators and continuous investment in technology and research, we can transform the landscape of diagnosis and control of notifiable diseases in Brazil, paving the way for a healthier and more resilient future.  We invite industry leaders to join us on this journey of innovation and impact.  Explore how your company can contribute to the transformation of disease diagnosis in Brazil and position itself at the forefront of global public health. Together, we can make a difference.  #RegulatoryAffairs #BrisaAdvisors #BPOinRA #MedicalDevices #IVD #MedicalTechnology  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

Navigating regulatory complexities in Brazil is a challenge for many companies, especially those operating in the healthcare field. In this context, understanding the differences between the Operating Authorization for Companies (AFE) and the Special Authorization (AE), as well as their applicability in registering products and services with the National Health Surveillance Agency (ANVISA), is crucial. This article seeks to clarify these differences and provide guidance on the applicability of each in the regulatory process.  What is AFE?  AFE is a mandatory license for companies involved in the production, distribution, storage, and transportation of products subject to health surveillance, including medications, food, cosmetics, sanitizers, among others. This authorization is issued by ANVISA and ensures that the company complies with the necessary technical standards and regulations for its operation. Obtaining the AFE is the first step for a company to start its activities in the healthcare sector.  What is AE?  Special Authorization (AE), on the other hand, is an additional requirement for companies intending to handle, store, distribute, or transport controlled products, including psychotropic substances, chemical precursors, among others. AE is, therefore, a complementary authorization to AFE, intended for a specific group of activities involving products with a higher level of control due to their potential risk to public health and safety.  Key Differences and Applicability:  The main difference between AFE and AE lies in the type of activity and products each company deals with. While AFE is broad and covers a variety of products subject to health surveillance, AE is specific to controlled products. This means that a company may only need AFE to operate, but if it decides to expand its activities to include controlled products, it will also need to obtain AE.  In the context of product registration with ANVISA, possession of AFE is a prerequisite for most processes. The company needs to prove its compliance with sanitary regulations before applying for product registration or notification. For controlled products, in addition to AFE, AE becomes an additional requirement, reinforcing the safety and control over these products.  Final Considerations:  Obtaining AFE and, when applicable, AE, is just the beginning of the regulatory compliance process for companies operating in the healthcare sector in Brazil. In addition to these authorizations, it is essential to stay updated with changes in legislation and technical standards, ensuring the continuity of operations and the safety of products offered to the market.  Understanding the difference between AFE and AE and their applicability is crucial for the success of companies in the healthcare sector and for the protection of public health. ANVISA plays a fundamental role in regulating and overseeing these activities, ensuring that only safe and effective products reach Brazilian consumers.  In the dynamic Brazilian healthcare sector, regulatory clarity and compliance are not just good practices – they are business imperatives. We hope this article has shed light on the path for your company to achieve not only compliance but also operational and market excellence.  Let’s navigate regulations together and pave the way for success in the healthcare sector!  #RegulatoryAffairs #BrisaAdvisors #BPOinRA #MedicalDevices #ANVISA #ANVISA #AFE #AE  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br