Transfer of ownership of registrations at ANVISA for Medicines, Active Pharmaceutical Ingredients, Cosmetics, Sanitizing Agents, Health Products and Food through commercial operations.
The Resolution No 233/2018, began to allow the transfer of registration ownership of products subject to Health Surveillance through commercial operations.
According to the Resolution, a commercial transaction between companies that results in the transfer of assets or a pool of assets, without any corporate transaction occurring between them.
The company that acquires the records through a commercial operation, which is the successor company, becomes responsible for such products as of the commercial operation’s effective date, that is, as of the date of the contract that formalized such commercial operation.
The deadline to petition ANVISA for the transfer of ownership of registrations of Drugs, Active Pharmaceutical Ingredients, Cosmetics, Sanitizing Products, Health Products and Food is 180 (one hundred and eighty days) days from the date of the commercial operation contract, from the date of execution of the contractual instrument of transfer of assets or of a set of assets.
About the Transfer of Ownership
- The responsibility will fall on the successor company before the entities of sanitary surveillance for the acts performed before the corporate or commercial operation.
- The stock of products subject to transfer of ownership is allowed for import and marketing by the new holder of the registration, provided that such products have been produced before the entry into force of the resolutions of cancellation and transfer of ownership of the registrations.
- The deadline for exhausting the stock of such products is 180 days from the date of publication of the resolutions cancelling and transferring ownership of the registrations.
- The Resolutions of cancellation and transfer of ownership of registration of products subject to sanitary surveillance become effective 90 (ninety) days after their publication.
- Transfer of ownership must be done by the Local Brazilian Registration Holder (BRH) in the Solicita system available on Anvisa’s website.
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GRP Brazil Office provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical, medical device, and life-consumers companies worldwide to register them product with ANVISA the local Health Authority (HA).
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.