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Portrait of Luz Helena Vargas

Luz Helena Vargas

Associate Director

CMS Rodríguez-Azuero
Calle 75 No.​ 3-53
Bogotá
Colombia
Languages Spanish

Luz Helena is an Associate Director for the Firm in the Sanitary Regulation team. She has over 14 years of experience advising national and foreign clients in matters of sanitary regulation in all procedures related to market approvals, and issues related to labelling, functional proclamations, and advertising approvals.

She leads the procedures and management of portfolios of health registrations at the national and international levels. She also has extensive experience in auditing processes (due diligences) for purposes of internal control and mergers and acquisitions of companies.

She has a vast experience in obtaining certification of facilities such as certification of Good Manufacturing Practices (GMP) of pharma products, renewal of Good Laboratory Practices (BPL) certification, production capacity of medical devices, storage capacity (CCAA), Certificate of technical production capacity or Certification of authorization, and approval of clinical studies protocols.

She also handles matters of Sanitary and Phytosanitary Regulation in the process of issuing sanitary licenses before the ICA in the sectors of animal husbandry and agricultural products and carrying out processes of Plant Breeder Rights.

Professional Experience

  • 2018-present – Associate Director, CMS Rodríguez-Azuero, Bogotá, Colombia
  • 2010-2017 – Partner, Mutter & Asociados S.A.S., Bogotá, Colombia
  • 2007-2010 – Associate, Departamento de Registro Sanitarios, Cavelier Abogados, Bogotá, Colombia
  • 2004-2007 – Legal Director, Naturcol LTDA., Bogotá, Colombia
  • 2003-2004 – Intern, Departamento Administrativo de la Función Pública. DAFP – Proyectos especiales, Bogotá, Colombia

Recognitions:

  • Luz Helena Vargas, Legal 500 Latin America 2021, Life Sciences, (Rising Star and Recommended Lawyer)
  • Luz Helena Vargas, Chambers Latin America 2021, Life Sciences (Associates to watch)

 

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Memberships & Roles

  • Active member of the "Independent Regulatory Association" an association of companies and legal advisors that carry out practice and lobbying issues before INVIMA.
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Education

  • 2009 – Specialization in Corporate Law, Universidad Colegio Mayor de Nuestra Señora del Rosario, Bogotá, Colombia
  • 2004 – Lawyer, Universidad Autónoma de Colombia, Bogotá, Colombia
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29 April 2021
Privates are still not al­lowed to im­port cov­id- 19 vac­cines even though...
Con­sid­er­ing the world health crisis, the Colom­bi­an Gov­ern­ment in search of over­com­ing the pan­dem­ic through a gen­er­al im­mun­iz­a­tion, is­sued Res­ol­u­tion 507 of 2021 which au­thor­izes privates to im­port vac­cines...
23 December 2020
Vac­ci­in­eees!!!
We don't have to say again what we've already said count­less (too many) times about all that this year has meant to us, our fam­il­ies, and all as­pects of our lives.And des­pite the fact that this year has...
27 April 2020
Pro­ced­ures of San­it­ary Reg­u­la­tion for “Non-In­dis­pens­able” Products in times...
In these strange times, the role of health au­thor­it­ies in re­gard to product man­age­ment is es­sen­tial to prop­erly handle and ward off the crisis. In Colom­bia, the au­thor­ity in charge of grant­ing au­thor­iz­a­tion...
20 April 2020
Phar­ma­ceut­ic­al ad­vert­ising reg­u­la­tion and med­ic­al device ad­vert­ising in...
1. Which laws are ap­plic­able re­gard­ing ad­vert­ising of medi­cines and med­ic­al devices? 1.1 Medi­cines De­cree 677/1995Res­ol­u­tion 4536/1996Res­ol­u­tion 4320/2004 1.2 Med­ic­al devices De­cree 4725/2005 2. Are...
20 April 2020
Can­nabis law and le­gis­la­tion in Colom­bia
Med­ic­al use Grow­ing, selling and im­port­ing can­nabis for med­ic­al use is al­lowed in Columbia.There are sev­er­al au­thor­it­ies in­volved in the au­thor­isa­tion pro­cesses. The ICA (the Colom­bi­an Agency for Ag­ri­cul­tur­al...
13 April 2020
Colom­bi­a's Health Au­thor­ity ad­apts to COV­ID Health Emer­gency: On­line pro­ced­ures,...
This whole text is cur­rently not avail­able in Eng­lish be­cause of its loc­al fo­cus. It refers to IN­VIMA de­clar­ing the sus­pen­sion of pro­ced­ur­al dead­lines for cer­tain pro­ced­ures con­sidered non vi­tal, the...
08 July 2019
Policy of Pre­ven­tion of Anti-Ju­di­cial Dam­age and De­fense Of IN­VIMA In­terests
The ul­ti­mate goal for IN­VIMA is to pro­tect the Pub­lic Health. Be­cause of this, their activ­it­ies are very rel­ev­ant for the pop­u­la­tion in gen­er­al. However, when this au­thor­ity fails or is wrong at a de­cision...