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Brazil proposed resolution establishes the minimum requirements for the registration of Hyperimmune Serum

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Brazil proposedresolution establishes the minimum requirements for the registration of Hyperimmune Serum

Brazilian Health Regulatory Agency (Anvisa) proposed Resolution establishes the minimum requirements for the registration of Hyperimmune Serum in order to guarantee the quality, safety and efficacy of these products. It applies to Hyperimmune Serum submitted for analysis for registration purposes.

Due to the biological origin of its Active Principles and the diversity of the technological processes used to obtain these products, all requests for the registration of Hyperimmune Serum will be analyzed according to the requirements established in this Resolution.

Only Hyperimmune Serum registered at the Brazilian Health Regulatory Agency - Anvisa, manufactured or imported by establishments authorized by the Federal Government and licensed at a state level, may be marketed and distributed in Brazil.

The Hyperimmune Serum manufactured in other countries may only be Authorized (registered) by Anvisa if the product is registered and liberated for use in its country of manufacture. Hyperimmune Serum not registered in their country of manufacture, but registered in another country due to epidemiological necessity, may be registered with Anvisa, after evaluation of the documentation presented, provided that the epidemiological impact of its use in Brazil is proven.

Only those Hyperimmune Serum with their validated manufacturing process will be registered and have at least one method of inactivation and / or viral removal validated in their manufacturing process will be registered.

For products manufactured in other countries, the latest periodic pharmacovigilance report shall be submitted, if available.

Product covered: Blood

HS code: 3002

Proposed date of adoption: NA

Proposed date of entry into force: NA

Final date for comments: NA

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.

 


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