Check list RDC 200: registration process

I – form Model 1 Administrative

II - proof of payment fees Administrative

III - Final version of the leaflet(PIL)

texts/warnings/instructions of use of the drug in
portuguese language
IV - primary and secondary packaging layout

V - Copy of the valid Good Manufacturing Practices

Certificate (GMPC) issued by ANVISA, for the
production line in which the drug, subject for
registration, will be manufactured. OR the
respective sworn translation or a copy of the
protocol requesting for the GMP inspection;

I - sobre o insumo farmacêutico ativo (IFA):

a) nomenclature: Brazilian Common Denomination

(DCB);

b) structure: structural formula including relative

and absolute stereochemistry, molecular formula,
and relative molecular mass;

c) physicochemical properties: physical form,

stoichiometric relationship between the chemical
presentation form of API and its
pharmacodynamically active component, melting
point, solubility, particle size and pKa;
d) API’s manufacturer name with complete address,
person to contact (e-mail) and Document of the
official sanitary organ of the country of origin
proving authorisation for the activity of
manufacturing API;

e) synthesis process description: synthesis process

flowchart, including molecular formula, chemical
structures of starting materials, intermediates and
their nomenclatures, solvents, catalysts, reagents
and the API, contemplating stereochemistry;

f) elucidation of structure and other characteristics

and impurities: structure confirmation based on
synthesis route and spectral analysis,
contemplating the infrared spectrum of the
molecule and other analyzes necessary for the
correct identification and quantification of the
molecule (s), and information on potential
structural and geometric isomerism, specific optical
rotation, refractive index, chirality, potential to
form polymorphs, discriminating their
characteristics and other API-related polymorphs,
and information about impurities;

g) quality control: specification, justification of

specifications for non-pharmacopeial API, analytical
methods used and respective validation (if
applicable) and batch analysis report issued by the
API manufacturer;

h) stability: a summary of the studies conducted

and their results, including the results of forced
degradation studies and stress conditions and their
analytical procedures, as well as conclusions on the
expiry date or retest date and packaging material.

II - formulation development:
a) summary of the formulation development taking
into consideration the route of administration and
use as well as the packaging system;

b) information about the compatibity between API

and excipients, the main physicochemical
characteristics of the API that can influence the
performance of the finished product;

c) manufacturing documents detailed,

characterization, and bibliographic reference to
support the safety data for excipients which is used
for a first time in a medicine composition, or in a
new route of administration;

d) data and discussion about the efficacy evaluation

of the preservative system(s) used in the
formulation;

e) justification in case of excess of API.

III – final product:

a) Qualitative and Quantitative formula (in

weight/volume and percentage) of the product
with DCB nomenclature of the components
(including scientific name); function of each
component of the formula, CAS nº, properly
legalized by the Consulate (if it is not attached to
the Certificate of Free Sale) signed by legal and
technical responsibles of the manufacturer.
Indication of the respective quality specification
references described in the Brazilian
Pharmacopoeia or other official codes authorized
by the specific legislation in force;

c) detailed description of the qualitative and

quantitative proportion of intermediate products
used in the finished product formula;

IV - about finished product production:

a) production dossier (batch record) for 1 (one) lot;

b) name and responsibility of each manufacturer

including contractors and each proposed
manufacturing site involved in the production and
testing to be performed, including quality control
and accelerated and long-term stability studies;

c) Flowchart with manufacturing process steps

showing where materials enter in the process,
identifying the critical points in the process and the
points of control, intermediate testing and final
product control;

d) information on batch sizes of finished product,

description of manufacturing process steps
including all parameters used, process control and
intermediate products;

e) list of equipment involved in production,

identified by operating principle (class) and design
(subclass) with their respective capabilities;

f) control of critical steps with information on

testing and acceptance criteria performed at critical
points identified in the manufacturing process, as
well as in-process controls;

g) summary report of the validation of the

manufacturing process, including batches,
definition of critical manufacturing steps with their
justifications, evaluated parameters, and indication
of the results obtained and conclusion.

V - sobre o controle de qualidade das matérias-

primas:

a) especificações, métodos analíticos e laudo

analítico para os excipientes, acompanhados de
referência bibliográfica, feitos pelo fabricante do
medicamento;
b) informações adicionais para os excipientes de
origem animal de acordo com a legislação
específica vigente sobre controle da Encefalopatia
Espongiforme Transmissível;

c) especificações, métodos analíticos e laudo

analítico para o insumo farmacêutico ativo,
acompanhados de referência bibliográfica,
realizados pelo fabricante do medicamento.

VI - sobre o controle de qualidade do produto

terminado:

a) especificações, métodos analíticos e laudo de

análise, acompanhados de referência bibliográfica,
incluindo relatórios de validação de método
analítico;

b) gráfico do perfil de dissolução, quando aplicável.

VII - sobre a embalagem primária e embalagem

secundária funcional;

a) descrição do material de embalagem;

b) relatório com especificações, método analítico e

resultados do controle de qualidade de embalagem.

VIII - sobre o envoltório intermediário:

descrição do material de constituição do envoltório

intermediário e suas especificações;

IX - sobre os acessórios que acompanham o

medicamento em sua embalagem comercial:
descrição do material de constituição do acessório
e suas especificações;

X – sobre os estudos de estabilidade do produto

terminado:
a) relatório com os resultados dos estudos de
estabilidade acelerada e de longa duração
conduzidos com 3 (três) lotes, protocolos usados,
incluindo conclusões com relação aos cuidados de
conservação e prazo de validade;

b) resultados de estudos de estabilidade para

medicamentos que, após abertos ou preparados,
possam sofrer alteração no seu prazo de validade
original ou cuidado de conservação original;

c) resultados do estudo de fotoestabilidade ou

justificativa técnica para a isenção do estudo;

Additional documents required:

Authorization delivered by the manufacturing
allowing the commercialization of the product in
Brazil

Certificate of Free Sale legalized by the Consulate or

recognized by an Official Institution in the country
of origin.

Informations proving that the product is not

contaminated by "Transmissible Spongiform
Encephalopathy", if applicable