Boletim Kestener & Vieira Advogados

Anvisa updates criteria for registration of probiotic medicines

Beatriz M A Camargo Kestener, Guilherme Gieron Fonseca e Silva and Daniel Kenzo Sato Mir, Kestener & Vieira Advogados

On 6 July 2022, the National Health Surveillance Agency (Anvisa) published Resolution RDC No 718/2022 (Portuguese language) which provides for the registration, changes, and revalidation of probiotic medicines.

According to the resolution, probiotic medicines are preparations or products containing defined and viable micro-organisms in sufficient quantity to prevent or treat human diseases by interacting with the microbiota, the intestinal epithelium, the associated immune cells, or by another mechanism of action.

Through its various new provisions, RDC No 718/2022 provides that:

• Only probiotic medicines registered with Anvisa (manufactured or imported by establishments duly authorized under the terms of Resolution RDC No 16/2014 (Portuguese language), and properly licensed by the state government) can be marketed, distributed, and used in Brazil.
• Probiotic medicines manufactured abroad can only be registered in Brazil if previously registered and approved for use in their country of origin and/or manufacture.
• If the active component (micro-organism) of the probiotic medicine is manufactured by another company, the applicant must declare its origin during the registration process of the probiotic medicine.
• The probiotic medicine registration applicant must demonstrate, in documents, that the product is manufactured in accordance with Good Manufacturing Practices (GMP) for pharmaceuticals.

The new resolution will enter into force on 1 August 2022 and will revoke Resolution RDC No 323/2003 (Portuguese language).

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Anvisa implements post-approval changes for herbal medicines and traditional herbal products

Beatriz M A Camargo Kestener, Guilherme Gieron Fonseca e Silva and Daniel Kenzo Sato Mir, Kestener & Vieira Advogados

On 6 July 2022, the National Health Surveillance Agency (Anvisa) published Resolution RDC No 708/2022 (Portuguese language) which provides for post-approval changes of herbal medicines and traditional herbal products.

According to RDC No 708/2022, in cases where the post-approval change or inclusion of the manufacturing location does not result in changes to the production process and equipment, the company may implement the change or inclusion within 60 days after the date of filing the petition.

The resolution also includes a 60-day term (from the filing date of the post-approval change petition) for companies to implement changes regarding the inclusion of size batches at least ten times bigger (subject to no contrary statement from Anvisa).

Regarding the product change history (PCH) (a document available in the company in which information regarding the annual history of the product must be recorded), RDC No 708/2022 states that:

•  Any inclusion of a new quality control test in the tests already approved will be implemented immediately and must have the methodology included in the PCH.
• The PCH must be filed with Anvisa annually, in the month the registration expires, and may be subject to an audit by Anvisa.

The new resolution will enter into force on 1 August 2022, and will revoke Resolution RDC No 38/2014 (Portuguese language) and Normative Instruction No 5/2014 (Portuguese language).

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Anvisa updates criteria for good practices for human tissue for therapeutic use

Beatriz M A Camargo Kestener, Guilherme Gieron Fonseca e Silva and Daniel Kenzo Sato Mir, Kestener & Vieira Advogados

On 6 July 2022, the National Health Surveillance Agency (Anvisa) published Resolution RDC No 707/2022 (Portuguese language) which provides for good practices for human tissue for therapeutic use.

Following Public Consultation No 988/2020 (Portuguese language) and Resolution No 564/2021, (Portuguese language) the new resolution updates certain selection and exclusion criteria for tissue donors.

Through its provisions, RDC No 707/2022:

• Reduces the minimum period for individuals subjected to therapeutic use of tissues to be considered as donors (from 12 to six months).
• Reduces the minimum period for individuals with increased risk in relation to sexual practice to be considered as donors (from 12 to six months).
• Revokes the exclusion criteria that prohibits the donation of human tissue by male individuals involved in sexual practices with others of the same sex.

RDC No 707/2022 includes new exclusion criteria for the donation or therapeutic use of human tissues in respect of:

• Individuals on chronic renal replacement therapy in the last six months.
• Individuals with a history of using blood products in the last six months.

The new resolution will enter into force on 1 August 2022 and will revoke Resolution RDC No 55/2015 (Portuguese language) and Resolution No 564/2021  (Portuguese language).

Reproduced from Practical Law with the permission of the publishers. For further information visit https://uk.practicallaw.thomsonreuters.com/