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RDC 166_2017 – Analytical Methods Validation

. 04/08/17

RDC 166_2017 - Analytical Methods Validation

Extraordinary Information n° 68/2019

Informativos . 11/12/19

It was published on this date, the Resolution of the Collegiate Board – RDC No. 327/2019, which establishes the procedures and requirements for granting Sanitary Authorization for manufacturing, marketing, prescription, dispensing, monitoring and supervision of Cannabis products for medicinal purposes. It defines the category of Cannabis Product: industrialized product, object of Sanitary Authorization by ANVISA, intended for medicinal […]

EXTRAORDINARY INFORMATION Nº 08/2019

Informativos . 26/02/19

It was published in the Official Gazette of 26/02/2019 the Collegiate Board Resolution Nº 268, of February 25th 2019 proposing a change in Collegiate Board Resolution – RDC nº 234, of June 21st 2018 that rules the outsourcing of production steps, quality control analysis, transportation and storage of medicines and biologic products, and other measures. […]

EXTRAORDINARY NEWSLETTER Nº 26/2017

Informativos . 31/10/17

It was published on the Official Gazette, Section 1, from 10/19/2017, RDC 183 from 10/17/2017 that disposes about programs of inspection and administrative procedures to Grant Good Manufacturing Practices Certification for establishments that manufacture medical devices located abroad and in Mercosul. This Resolution establishes that ANVISA will evaluate the compliance of GMP primarily through […]

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