The National Health Surveillance Agency (Anvisa) has announced the publication of the Collegiate Board Resolution (RDC) 860/2024 at the beginning of this month. This new regulation has modified RDC 16/2014, which sets the criteria for petitioning for Operating Authorization (AFE) and Special Authorization (AE) for companies. To clarify the adjustments in the import consent processes for importers of goods and products subject to sanitary intervention, Anvisa has listed the companies exempt from AFE covered by RDC 16/2014, with the changes provided by RDC 860/2024.
Firstly, retail companies selling health products for lay use are exempt from AFE; however, if the company engages in import activities, it requires an AFE as stipulated in Article 3 of RDC 16/2014. Similarly, headquarters or branches of companies not engaged in activities with health products subject to AFE do not need an AFE, unless they participate in import activities, which would then necessitate an AFE as well.
Companies exclusively engaged in the manufacturing, distribution, storage, packaging, export, fractionation, transportation, or import of raw materials, components, and inputs not subject to special control, which are intended for the manufacture of health products, cosmetics, personal hygiene products, perfumes, and sanitizing products, are also exempt from AFE. However, if these companies import components for the replacement of medical devices, they are required to have an AFE as outlined in Article 3 of RDC 16/2014.
Exemptions and Requirements for Import Authorization in Health Equipment and Clinical Trials
Companies that solely perform the installation, maintenance, and technical assistance of health equipment are exempt from AFE. Nonetheless, if such companies import parts or accessories for the replacement of medical or diagnostic equipment, they need an AFE for importing medical devices.
Companies that import products exclusively for clinical trials, expanded access programs, compassionate use programs, and post-study drug supply programs are exempt from AFE provided they hold an authorization document issued by Anvisa, necessary for the execution of the respective program. This exemption applies to companies holding a Special Notice (CE), Specific Special Notice (CEE), and Import Document for Investigational Product(s).
However, imports conducted by entities other than the holder of the Clinical Development Dossier for Medicines (DDCM), Clinical Investigation Dossier for Medical Devices (DICD), Advanced Therapy Product Clinical Development Dossier/Simplified Dossier for Clinical Trials with Investigational Advanced Therapy Products (DDCTA/DSCTA) are not exempt from AFE.
Streamlined Import Authorization for Quality Control and Research in Health Sector
Companies importing products exclusively for quality control laboratory analysis or new product development are exempt from AFE. Companies that import goods and products classified under Chapter XXI of RDC 81/2008, exclusively for quality control or new product development, do not need an AFE for importation.
Scientific, technological, innovation, and experimental development institutions exclusively conducting basic or applied research of a scientific, technological, or new product, service, or process development nature are also exempt from AFE. Lastly, companies holding AE for Laboratories or Research Institutions importing products exclusively for their own use in research activities do not need to include the import activity in their AEs. This includes imports intended for the development of new products.
These exemptions aim to streamline the importation process for certain entities while maintaining stringent control over activities that directly impact public health. The adjustments to RDC 16/2014 through RDC 860/2024 ensure that companies and institutions involved in health-related activities are well-regulated, facilitating safer and more efficient import practices.
Resource: National Health Surveillance Agency, June 04, 2024
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