Last Updated on September 30, 2024 by The Health Master
Argentina
Great news for Indian pharma companies! The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has announced a major breakthrough in regulatory cooperation between India and Argentina, opening doors for increased exports of Indian medicines to the South American nation.
Simplified Registration Process
This exciting development follows a meeting between the Indian Ambassador to Argentina and Uruguay and Argentina’s Health Minister, Dr. Mario Russo.
Dr. Russo clarified the regulatory procedures for Indian pharmaceuticals entering the Argentine market.
Here’s the key takeaway:
Indian pharmaceutical products with Good Manufacturing Practices (GMP) certification from high-level health surveillance agencies listed in Annex I of Decree 150/92 can be registered with Argentina’s National Administration of Drugs, Foods, and Medical Devices (ANMAT) under a simplified registration system.
This means faster market access for Indian drugs in Argentina!
Streamlined Process
India boasts a robust pharmaceutical industry, with many laboratories already holding GMP approvals from prestigious regulatory authorities in Annex I countries like the United States and the European Union.
This existing recognition significantly streamlines the registration process with ANMAT for Indian companies.
Argentina’s Growing Pharmaceutical Market
Argentina represents a lucrative market with a rising demand for high-quality medicines.
This simplified registration process presents a golden opportunity for Indian pharma companies to expand their footprint in this promising market.
Pharmexcil Encourages Swift Action
Pharmexcil is urging its member companies to seize this opportunity by promptly submitting product registrations to ANMAT, along with the necessary documentation proving their GMP certifications from Annex I countries.
Expert Guidance Available
To ensure a smooth registration process, Pharmexcil is offering support to its members.
Raja Bhanu, Director General of Pharmexcil, highlighted the importance of taking advantage of this streamlined process.
“We strongly encourage our members to begin registering their products with ANMAT as soon as possible.
This will pave the way for significantly larger exports of Indian pharmaceuticals to Argentina,” stated Bhanu.
He further added that companies facing challenges during registration or dealing with ANMAT can reach out to Lakshmi Prasanna, Senior Director at Pharmexcil (regulatory@pharmexcil.com) for assistance.
Strengthening Trade Ties and Expanding Reach
This breakthrough in regulatory cooperation marks a significant step forward for both India and Argentina.
It not only facilitates smoother entry of Indian pharmaceuticals into the Argentine market but also strengthens trade relations between the two countries.
This paves the way for further growth and expansion for Indian pharma companies in the vast Latin American market.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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