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Brazil proposed administrative procedure related to Anvisa's prior consent for the granting of patents for pharmaceutical products and processes

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Brazil proposed administrative procedure related to Anvisa's prior consent for the granting of patents for pharmaceutical products and processes

This Resolution provides for the administrative procedure related to Anvisa's prior consent for the granting of patents for pharmaceutical products and processes, regulated by Joint Ordinance ANVISA-INPI nº 01, of 12 April 2017.

The prior consent procedure will begin with fowarding of the application by INPI to Anvisa, pursuant to art. 2 of Joint Ordinance No. 1, of 12 April 2017.

Upon receipt of patent applications forwarded by INPI, Anvisa will analyze such requests in the light of public health and will conclude by consent or non-consent based on a technical evaluation by the competent organizational unit within ANVISA.

The petitions and documents referred to in this Resolution will be received in accordance with Anvisa's specific protocol regulation.

The provisions of this Resolution also apply to current patent applications and those who have closed the administrative instance within Anvisa .

Resolutions RDC - nº 45, of 20 June 2008 and RDC - nº 21, of 10 April 2013 are revoked.

This Resolution shall enter into force on the date of its publication.

Products covered: Pharmaceutical Products

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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