Legal & Regulatory > Argentina

The COVID-19 pandemic has caused economic and social disruption and affected the behaviour of both consumers and producers in Argentina, with an important impact on Argentine currency (ARS) devaluation and inflation, among others. We are not yet able to measure the real impact of the uncertainty the world is currently facing and its impact on the country.   In December 2019, President Macri ended his term and Alberto Fernandez took office with Cristina Kirchner as vice president, after having promised…

All legal aspects surrounding biosimilars & biologics in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   1. Are biosimilar medicines considered the same as generic medicines in your country? No, biosimilar medicines have their own legal regime. ANMAT does not use any specific term such as “biosimilar” or “biocomparable”, but defines this type of biological medicines as: “medicinal…

The low-down on the situation regarding localization in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? As a preliminary comment, please note that to carry out activities in Argentina on a permanent basis,…

Keen to learn more about orphan drugs & rare diseases in Argentina? Read on! Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   1. What is the definition of Rare Diseases in your country? According to Law No. 26,689 on Rare Diseases, rare diseases are considered to be those whose prevalence in the population is equal to or less than…

On October 27th, 2019, presidential candidate Alberto Fernández was elected president of Argentina defeating the Macri Administration with more than 48% of votes. The key proposals of Fernández’s political campaign were based on socially-friendly reforms, such as helping the most vulnerable population to progress in the struggling economy, aiding the local industry and blue-collar workers, and ending with the increasing external debt and economic crisis. Another key element to the campaign was his political message promising everyone’s better access to…

Key legal info on cannabinoid drugs, medicinal cannabis and opioid drugs in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? The usage of Cannabinoid Drugs in Argentina is only authorized for medicinal purposes (medicinal cannabis). Please see Questions 12 to 14 of this Chapter for further information about…

An insight into upcoming regulatory reforms affecting Argentinian pharma. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   1. Are there proposals for reform or significant change to the healthcare system? There are no proposals for reform or significant change of the healthcare system in the short term. Nonetheless, due to the COVID-19 pandemic, several new regulations and laws have…

A legal briefing on patents and trademarks in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   1. What are the basic requirements to obtain patent and trademark protection? Patents To obtain patent protection in Argentina, it is necessary to file a patent application with the National Institute of Industrial Property (the “INPI” after its acronym in Spanish). The…

Intro to product liability in Argentinian pharma. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   1. What types of liability are recognized in your jurisdiction? In general terms, liability arises from provisions in the Argentine Constitution, the Civil and Commercial National Code, the Criminal Code, and other laws that apply to specific cases such as the Corporate Criminal Liability…

The environment surrounding traditional and OTC products in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Herbal and vegetable medicines are regulated by ANMAT. They are defined as medicine that contains as an active ingredient one or more plant medicines, or one or…

Outlining the legal situation for marketing, manufacturing, packaging & labelling in Argentinian pharma. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? See answers to Questions 2 and 3 in Regulatory, Reimbursement and Pricing Overview.   2. What is…

Preclinical and clinical trial requirements in Argentina – a legal guide. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. It is not a condition for marketing approval to conduct a clinical trial in Argentina (the approval of pharmaceutical…

A brief overview of the situation regarding regulation, pricing and reimbursement of drugs in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The National Ministry of Health (“MoH”) is the main health authority in Argentina. Nonetheless, in the year…