How to register APIs in Brazil - Live Online Training

Thursday, 13 February 2025 10.30 - 15.45 h

Course No. 21625

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Speakers

Marieke van Dalen

Marieke van Dalen

MARA Consultancy, The Netherlands

Dr. Susan Swiggers

Dr. Susan Swiggers

Aspen Oss

All times mentioned are CET.

Background

Since August 2020, the “CADIFA Manual of Administrative Procedures” of the Brazilian Health Regulatory Agency (Anvisa) is valid and needs to be followed for API dossiers. Now, the new version of the “CADIFA Manual” is published and available in Portuguese and in English language.1

According to the agency, the DIFA (Active Pharmaceutical Ingredient dossier) must be submitted to Anvisa by the DIFA holder to receive a CADIFA (letter of suitability of the active pharmaceutical ingredient). It shows the compliance of a DIFA with the regulatory requirements. A valid CADIFA and GMP certificate are necessary for the approval of an associated marketing authorization or post-approval change application.1

The understanding of Brazilian Registration Procedures for APIs is thus important to know. This Live Online Training provides an overview of the regulatory and GMP requirements for registering APIs in Brazil and obtaining the Brazilian GMP certificate.
 
1 Source: CADIFA Manual for Administrative Procedures, CADIFA Manual nº 01, 2nd Version

Target Group

This Live Online Training has been developed for all who are dealing with API Sourcing, Manufacturing, Quality Assurance and Regulatory Affairs.

Technical Requirements

We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

How to register APIs in Brazil - Live Online Training

Seminar Programme as PDF

How to Handle Brazilian Registrations
  • Different ways of submitting API information
  • Procedural aspects
  • Guidelines
Content of the Registration File
  • The CADIFA system
  • The DIFA (API dossier)
  • What is different from other regions?
Handling Changes in Brazil
  • Relevant guidelines
  • How does it work in practice?
Obtaining the Brazilian GMP Certificate
  • Starting the GMP certificate procedure
  • Different sites & different classes of products

ECA-Member*: € 690,-
Regular Fee*: € 790,-
EU/GMP Inspectorates*: € 690,-
APIC Member Discount*: € 740,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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