top of page

Downloadable Materials

RDC 763 OF 25.11.2022

Comparativo RDC 166 X CP 1391 x ICH

Image by pina messina

RDC 753 OF 28.09.2022 | REGULATION FOR SYNTHETIC REGISTRATION

See at:

SYNTHETIC AND SEMI-SYNTHETIC

Image by Kimzy Nanney

RDC 327 OF 12/09/2019

SANITARY AUTHORIZATION

Veja em:

CANNABIS

BIOLOGICAL

RDC 413 OF 20.08.2020 [POST-REGISTRATION]

BIOLOGICAL

RDC 413 OF 20.08.2020 [POST-REGISTRATION]

RDC 55 OF 10/16/2010 [REGISTER]

IN 65 OF 27.08.2020 [POST-REGISTRATION]

CANNABIS

RDC 327 OF 9.12.2019 [HEALTH AUTHORIZATION]

CTD

CTD GUIDE N24'2019 | V1

CTD GUIDE N24'2019 | V2

CTD GUIA N24'2019 | ANNEX I | M1

CTD GUIA N24'2019 | ANNEX II | M2-M3

CTD GUIA N24'2019 | HMP

CTD GUIDE N24'2019 | PETITIONS WITHOUT IMPACT ON CTD

Q&A GUIDE 24'2019 | V1

CTD GUIA N24'2019 | ANNEX III | M2-M4

PROPOSED NOMENCLATURE FOR SINDUSFARMA

CTD GUIA N24'2019 | ANNEX IV | M2-M5

DIFA & CADIFA

RDC 359 OF 03/27/2020 | DIFA AND CADIFA

RDC 361 OF 03/27/2020 | DIFA AND CADIFA

RDC 362 OF 03/27/2020 | DIFA AND CADIFA

RARE DISEASES

RDC 205 OF 28.12.2017

RDC 763 DE 25.11.2022

SPECIFIC

RDC 76 OF 02.05.2016 | POST-REGISTRATION | SPECIFIC

RDC 24 OF 14.06.2011 | REGISTRATION OF SPECIFIC MEDICINES

PHYTOTHERAPEUTICS

RDC 708 OF 01.07.2022 | POST-REGISTRATION OF PHYTOTHERAPEUTICS

RDC 26 OF 13.05.2014 | REGISTRATION OF HERBAL MEDICINES

ADMINISTRATIVE GUIDES

OS 59 OF 13.03.2019 | ADDITIONS TO REGISTRATION APPLICATIONS

RDC 433 OF 11/05/2020 | GA FILING OF PROCESS

RDC 204 OF 12/28/2017 | ANALYSIS PRIORITIZATION

TECHNICAL GUIDES

RDC 37 OF 08/05/2011 | BIOEQUIVALENCE

RDC 472 DE 23.02.2021 | BIOEQUIVALÊNCIA

RDC 479 OF 03/12/2021 | BIOEQUIVALENCE

RDC 31 OF 11.08.2010 | PHARMACEUTICAL EQUIVALENCE

IN 63 OF 22.07.2020 | PHARMACOVIGILANCE

RDC 406 OF 22.07.2020 | PHARMACOVIGILANCE

RDC 53 OF 12/04/2015 | DEGRADATION PRODUCTS

RDC 166 OF 24.07.2017 | ANALYTICAL VALIDATION

RDC 318 OF 11/06/2019 | STABILITY STUDIES

RDC 412 OF 27.08.2020 | STABILITY STUDIES

CLINICAL RESEARCH AND ACCESS

RDC 311 OF 10/10/2019 | ACCESS

RDC 38 OF 12.08.2013 | ACCESS

THE 104 OF 17.06.2021 | CLINICAL RESEARCH

RDC 172 OF 09/08/2017 | PES CLINIC

RDC 601 OF 02/09/2022 | PES CLINIC

RDC 9 OF 02/20/2015 | PES CLINIC

SYNTHETIC AND SEMI-SYNTHETIC

RDC 219 OF 27.02.2018 | POST-REGISTRATION CONDITIONAL APPROVAL

RDC 73 OF 04/08/2016 | POST-REGISTRATION SYNTHETICS

FIDR JUL'22 | REGISTRATION | TEMPLATES

[ENG] FIDR JUL'22 | REGISTRO | TEMPLATES

RDC 753 OF 28.09.2022 | REGULATION FOR SYNTHETIC REGISTRATION

bottom of page