PXL/HO/Cir-042/2024-25                                                                            Date: 06.08.2024

Hyderabad

Subject: Facilitating greater exports to Argentina

Pharmexcil is in receipt of a communication from Ambassador of India to Argentina and Uruguay  wherein he has referred to his meeting with Dr. Mario Russo, Health Minister, Argentina, on  measures to facilitate smoother and larger exports of our pharmaceuticals to Argentina and communicated the following clarification provided by the Argentine Health Ministry in this regard: 

"if the Indian laboratory has a relevant certification of compliance with GMP issued by a high-level health surveillance agency, established in Annex I, Decree 150/92. Therefore, there are no barriers to the entry of Indian products. Such product may be authorised by ANMAT, under the simplified system outlined in Article 4, and be marketed in Argentina for human consumption." 

 Ambassador has suggested that since India has a large number of laboratories that have approvals from the regulatory authorities of Annex I countries, particularly US and European, the registration of their products could be undertaken in a simple and speedy manner. 

Accordingly, we encourage our member companies to begin registering their products with ANMAT along with relevant documentation proving their approvals from Annex I countries (list attached).  This will facilitate Indian exports to Argentina.   

Incase of any practical challenges the Indian pharma industry faces while dealing with ANMAT, Argentina, kindly share the details with Ms.Lakshmi Prasanna, Senior Director (regulatory@pharmexcil.com) 

Regards

Raja Bhanu

Director General 

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