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ANVISA_Novas regras para Medicamentos e Produtos Alergênicos / New rules to medications and allergenic products

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3/20/2015 9:00 PM Demarest News

New rules to medications and allergenic products

As from 3/18, all interested parties may participate in the review of the rules applicable to medications and allergenic products.  

Public Consultation - CP no. 18/2015 set a term of 30 days for the submission of comments and suggestions to the text providing for post-registration changes and cancellation of medication registrations, related to the review of Resolution–RDC no. 48/2009, as provided for in the text of the Consultation. 
A 60-day term has also started for the submission of comments and suggestions to the wording in CP no. 19/2015, concerning the review of Resolution-RDC no. 233/2005, which provides for the registration and post-registration changes of manufactured allergenic products, in accordance with the terms addressed in this Consultation. 
These text proposals are available on ANVISA’s website and the suggestions shall be submitted by a specific form. 
The participation of the regulated sector by sending their contributions to the proposed Consultations is of paramount importance, in view of the impact that the future regulation will have on the companies’ activities and daily routines.
We have monitored the discussions on the subject and placed ourselves at your service to provide any clarifications on the present resolution.
Demarest Advogados
Public and Regulatory Law
​Renato Poltronieri ​ ​55 11 3356-1828
​Elisa Aparecida Athaide ​55 11 3356-2046
​Marina Roversi Zago ​55 11 3356-1868

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