Introduction to Marketing Authorization Regulations in Latin America
[Thursday, 16th Mar 2023]
Introduction to Marketing Authorization Regulations in Latin America
Alessandra Rolim / Milena Barrozo
Vita Regulatory Affairs Consulting

In last years, Latin America has become one of the regions which many pharmaceutical industries are focusing their projects, considering the population, the requirements, the economy.

However, Latin America is made up of several countries and, regarding the registration of medicinal products, these countries do not follow the same legislation and do not have the same requirements and submission processes.

During this webinar with Milena Barrozo and Alessandra Rolim, Regulatory Affairs Consultants at Vita Regulatory Affairs Consulting, we will be discussing the main requirements for Marketing Authorization of Medicinal Products in some countries from this region. We will provide viewers with an understanding of these general requirements, along with practical advice.


1. Introduction to Latin America

  • Countries to be covered during the training and general characteristics 

  • Regulation development in the region: diverse regulations, constant updates 

  • National Regulatory Authorities (NRA) 

  • PAHO Reference NRAs 

  • NRAs in global harmonization initiatives (ICH, ICMRA, PIC/s) 

2. Brazil

3. Colombia

4. México

5. Argentina

6. Peru

(For each country, a general approach regarding Health Authority, Legal Framework, GMP Certifications, Marketing Authorization, General Pharmaceutical Evaluation Requirements).

Alessandra Rolim
Regulatory Affairs Consultant at Vita Regulatory Affairs Consulting
Alessandra is based in Brazil. Since 2004, Alessandra has been working in regulatory affairs, for pharmaceutical and cosmetic industries, for Brazil and other Latin America countries, responsible for marketing authorization and post-approval strategies and processes. She holds degrees as Pharmacist and in a specialization course in Business Administration.
Milena Barrozo
Regulatory Affairs Consultant, Co-founder and Director at Vita Regulatory Affairs Consulting
Milena is based in Brazil. Since 2007 is working in the pharmaceutical industry field such as quality assurance, quality control and, mainly, regulatory affairs. National and international experience. She has been responsible for the CTD trainings and pilot projects in several Brazilian Pharmaceutical Industries, as well as trainings and projects to Europe. Industrial Pharmacist with MBA degree in Business Management; post-graduation in Regulatory Affairs; Personal and Professional Coach; Master's degree in Regulation and Evaluation of Medicines and Health Products for Europe.
If you have any question about this webinar, please contact us:
+86 (0)571 8710 3829