Argentina’s Pharmaceutical Crossroads: A Strategic Guide to Navigating Deregulation, Risk, and Radical Opportunity

Introduction: The High-Stakes Game in a Market of Dualities

Welcome to Argentina. For the seasoned pharmaceutical executive, market strategist, or investor, these two words conjure a complex tapestry of thought: immense potential woven with threads of profound risk, a history of scientific achievement shadowed by economic volatility, and a marketplace defined by a fierce, almost gravitational, pull between protectionist legacy and the shockwaves of radical, free-market reform. To operate here is to navigate a landscape of dualities, where the rules of the game can shift with the stroke of a presidential pen, yet the underlying institutional structures remain stubbornly resilient.

This is not a market for the faint of heart, nor is it one that rewards a superficial, one-size-fits-all approach. Argentina stands today at a dramatic crossroads. The recent, aggressive deregulatory push by the new administration represents one of the most significant economic experiments in the country’s modern history, directly targeting the healthcare and pharmaceutical sectors. This has created an environment of unprecedented flux, where long-held commercial models are being dismantled overnight and new avenues for competition are being blasted open. But is this a genuine, sustainable shift towards a liberalized, innovation-friendly market, or another turn in the country’s cyclical dance with economic orthodoxy?

This report is designed to answer that question, but not with a simple yes or no. Our purpose is to move beyond the headlines and the legal text to provide a definitive, strategic playbook for senior industry professionals. We will demystify the intricate workings of Argentina’s regulatory gatekeeper, the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), dissect the pathways to market authorization, and illuminate the notorious minefield of its intellectual property system. More importantly, we will connect these disparate regulatory threads to the commercial realities on the ground, analyzing the payer landscape, the impact of hyperinflation, and the strategic calculus required to succeed.

For the IP, R&D, and business development teams we are addressing, the goal is not merely to understand the regulations but to master them. It is to transform this complex, often contradictory, landscape from a source of operational friction into a source of durable competitive advantage. The stakes are high, but for those who can navigate the currents with data, insight, and strategic agility, the rewards are commensurate. Let’s begin.

The Argentine Pharmaceutical Market at a Glance: Data, Dynamics, and a Looming Disruption

Before diving into the regulatory labyrinth, it is essential to ground our analysis in the hard data that defines the commercial battlefield. Argentina is not just a complex regulatory puzzle; it is a substantial, dynamic, and fiercely competitive market with a unique structure that is now facing its most significant disruption in a generation.

Market Snapshot: The Numbers that Matter

Argentina stands as the fourth-largest pharmaceutical market in Latin America, a significant player whose scale demands attention. In 2023, the market was valued at approximately USD 7.3 billion.¹ Despite the country’s well-documented economic headwinds, forecasts remain robust, projecting the market will more than double to reach nearly US$ 14.2 billion by 2030. This represents a compound annual growth rate (CAGR) of 4.4% from 2025 to 2030, a testament to the underlying resilience of healthcare demand.¹

The market’s composition reveals a heavy reliance on high-value products. Prescription drugs are the dominant force, accounting for a massive 88.5% of total sales. Within this segment, a further breakdown shows the market’s unique character:

Patented Drugs: Hold a 63.8% share of the prescription market.
Generic Drugs: Represent 24.7% of the market.
Over-the-Counter (OTC) Drugs: Account for the remaining 11.5% of total sales.¹

Looking forward, the engine of growth is expected to come from the most technologically advanced segment. Industry analysts consistently identify biologics and biosimilars as the fastest-growing category, signaling a clear market shift towards more complex and high-value therapeutics.¹

The Competitive Arena: Domestic Champions vs. Global Giants

The competitive landscape in Argentina is unlike that of many other major markets. It is not dominated solely by multinational corporations (MNCs). Instead, it is a battleground where some of the world’s largest pharmaceutical companies, such as Bayer, Pfizer, Sanofi, and Novartis, compete head-to-head with a formidable cohort of deeply entrenched and powerful domestic laboratories.¹

These local champions—most notably Roemmers, Bagó, Elea, and Gador—are not simply generic manufacturers. They are sophisticated, vertically integrated enterprises with extensive R&D, manufacturing, and commercial capabilities that have allowed them to build dominant market positions.¹ As Jim Harold, former Country President of Novartis Argentina, noted, “You just have to take a look at the IMS rankings, and you have to go a long way down to find a multinational company”.⁴ This intense rivalry between local and international players defines the market’s dynamics and shapes every aspect of commercial strategy, from pricing and marketing to government relations and supply chain management.

The Branded Generic Legacy and Its Imminent Demolition

To truly understand the Argentine market and the seismic nature of recent changes, one must grasp the concept of the “branded generic” or “similar.” The market data, showing a relatively modest 24.7% share for “generics,” can be misleading. For decades, the commercial sweet spot for local manufacturers has been the branded generic: an off-patent molecule sold under a strong, trusted brand name, often at a price point significantly higher than a true unbranded generic but still below the original innovator product.

This model thrived in a system where physicians exhibited high brand loyalty and generic substitution policies at the pharmacy level were weak or non-existent. The value was not in the molecule, but in the brand equity and the marketing muscle used to persuade prescribers. This entire, lucrative, and long-standing business model is now under direct assault.

The mandate within President Milei’s Decree 70/2023 that all medical prescriptions must only state the generic name of the medication—its International Nonproprietary Name (INN)—is a strategic torpedo aimed at the heart of the branded generic model.⁶ This single policy change is set to fundamentally rewire the commercial landscape. The immense value of a legacy brand for an off-patent drug is poised to evaporate. Competitive advantage will no longer be forged in the doctor’s office through marketing prowess; it will be determined at the pharmacy counter and in the supply chain, based on price, availability, and distribution efficiency. This is not a minor regulatory tweak; it is a pivotal, structural change that demands an immediate and profound strategic reassessment from every single participant in the Argentine pharmaceutical market.

The Gatekeeper: Deconstructing ANMAT, Argentina’s Powerful Regulatory Authority

At the very center of Argentina’s pharmaceutical universe sits a single, powerful institution: the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, universally known as ANMAT. To any company seeking to bring a product to the Argentine market, ANMAT is the ultimate gatekeeper. Understanding its structure, its mandate, and its unique institutional philosophy is not just a matter of regulatory compliance; it is a prerequisite for crafting any viable market access strategy.

Genesis and Mandate: The Strategic Significance of an “Autarchic” Agency

ANMAT was forged in a moment of national need. Established by Executive Decree 1490/92, its creation was driven by the necessity to bring order and scientific rigor to a fragmented and often chaotic drug registration system.⁷ From its inception, it was vested with a clear and sweeping mission: to protect the population by ensuring the efficacy, safety, and quality of all drugs, medical devices, and other health products sold in the country.⁹

However, the most strategically significant detail in its founding charter is a single, powerful legal term. ANMAT is defined as a decentralized and “autarchic” body.⁷ This is not mere legalese. “Autarchy” grants the agency a profound degree of financial and operational independence from the day-to-day political machinery of the central government. This structural insulation is the bedrock of its institutional credibility, both domestically and, crucially, on the international stage.

For companies operating in Argentina, this autonomy is a double-edged sword that ultimately provides a crucial element of stability. While ANMAT may at times seem bureaucratic or slow to adapt to the shifting political winds, its decisions are grounded in a consistent, science-based institutional logic. This makes it a relatively predictable counterpart, even when the broader economic and political environment is in turmoil. Its independence is the currency that allows it to engage as a peer with the world’s leading regulatory agencies, a fact that directly shapes its entire operational strategy.

Organizational Deep Dive: Mapping the Corridors of Power

ANMAT’s organizational chart reveals a structure designed for specialized oversight. At the top sits a National Administrator and a Deputy Administrator, who preside over a collection of powerful, semi-autonomous institutes and central offices.¹² For any pharmaceutical or biotech firm, understanding this internal map is key to navigating the system effectively. The directorates that matter most are:

National Institute of Drugs (INAME): This is the nerve center for all pharmaceutical regulation. Headed by a director, INAME is responsible for the evaluation, registration, and post-market surveillance of all medicinal products.
National Institute of Medical Devices: A parallel body with a similar mandate focused exclusively on medical technology, from simple disposables to complex implants.
National Institute of Food (INAL): Responsible for food safety and regulation.

Within INAME, the structure becomes even more specialized and strategically revealing. A key department is the Office of Evaluation and Control of Biologicals and Radiopharmaceuticals. This is not just another review division. It is an integrated unit that incorporates the Department of Facility Quality Assurance, the Department of the National Laboratory for Biologicals Control, and the Department of Product Evaluation and Marketing.¹³

This integrated structure for biologics is a powerful signal of ANMAT’s regulatory philosophy. It demonstrates that the agency views these complex products not simply as a clinical data package to be reviewed, but as an end-to-end challenge that spans the entire lifecycle from manufacturing and quality control to post-market performance. For companies seeking to register biologics or biosimilars, this means that a strong clinical dossier is necessary but not sufficient. Success hinges on an equally integrated strategy that anticipates rigorous scrutiny of Good Manufacturing Practices (GMP), batch-to-batch consistency, and quality control systems, as all these elements are assessed by a single, cohesive regulatory team.

ANMAT on the World Stage: The Harmonization-Reliance Flywheel

ANMAT has invested decades in painstakingly building a formidable international reputation. It is not an isolated, regional regulator; it is a respected participant in the global health ecosystem. This is evidenced by its formal designation as a Regional Reference National Regulatory Authority by the Pan American Health Organization (PAHO/WHO) and its recognition as a high-health vigilance agency at the global level.¹⁴

This standing is not accidental. It is the result of a deliberate and sustained strategy of international engagement. ANMAT is an active member of the most important global standard-setting bodies, including:

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
The Pharmaceutical Inspection Co-operation Scheme (PIC/S)
The International Coalition of Medicines Regulatory Authorities (ICMRA)
The International Medical Device Regulators Forum (IMDRF) ¹⁴

Furthermore, it maintains formal confidentiality and information-sharing agreements with its most important global counterparts, including the U.S. Food and Drug Administration (FDA).¹⁶

This deep international integration is not a diplomatic exercise; it is the engine of ANMAT’s domestic operational strategy. It creates a powerful, self-reinforcing cycle—a “flywheel effect”—that is essential to understanding how the agency functions.

Harmonization: By actively participating in bodies like ICH and PIC/S, ANMAT aligns its domestic technical requirements and review standards with the global consensus.
Trust Building: This alignment builds trust and credibility with other major regulatory agencies, who come to recognize ANMAT’s processes and decisions as being on par with their own.
Enabling Reliance: This foundation of trust is what makes it possible for ANMAT to implement domestic “reliance” pathways. It can confidently leverage the rigorous review work already completed by a trusted agency like the FDA or EMA, rather than duplicating the entire effort from scratch.
Efficiency Gains: Reliance dramatically increases ANMAT’s operational efficiency, allowing it to process applications and make decisions far more quickly than its resources would otherwise permit.
Reinforced Standing: This efficiency and adherence to global standards further enhances its international reputation, strengthening the entire cycle.

This Harmonization-Reliance Flywheel is the key to ANMAT’s ability to function as a high-vigilance agency. For companies, it means that the fastest and most efficient path to the Argentine market is almost always one that leverages a prior approval from a major, trusted international regulator.

The Rulebook: Decoding Argentina’s Legislative and Regulatory Framework

The legal and regulatory architecture governing pharmaceuticals in Argentina is a layered construct, built upon a foundation of decades-old laws that have been reshaped by modern decrees and, most recently, rocked by a deregulatory earthquake. To navigate this terrain, one must understand both the historical bedrock and the tectonic shifts that are currently redefining the landscape.

Foundational Pillars: Law 16,463 and the Birth of Modern Regulation

The cornerstone of all pharmaceutical law in Argentina is Law 16,463, enacted in 1964.¹³ This foundational piece of legislation establishes the state’s authority to regulate the entire lifecycle of medicinal products, from import and production to commercialization and dispensing. It is the original source code from which all subsequent regulations are derived.

The modern regulatory era, however, truly began with Executive Decree 1490/92. This was the instrument that created ANMAT, taking the broad principles of Law 16,463 and vesting their enforcement in a specialized, technically proficient, and autarchic body.⁷ Together, this law and decree form the twin pillars upon which the entire regulatory system is built.

The Deregulation Earthquake: A Tactical Analysis of Decree 70/2023

On December 20, 2023, the newly inaugurated administration of President Javier Milei unleashed Decree of Necessity and Urgency (DNU) 70/2023, a sweeping “mega-decree” designed to radically deregulate vast swathes of the Argentine economy.⁶ The healthcare and pharmaceutical sectors were squarely in its sights, and the resulting changes have been nothing short of revolutionary for the industry. The decree’s core objective is to dismantle protectionist barriers, ease restrictions on business, and inject a powerful dose of competition into the market.

The following table breaks down the most critical changes for the pharmaceutical sector, analyzing the “before and after” and, most importantly, the strategic implications for every market participant.

Table 1: Key Pharmaceutical Deregulations under Decree 70/2023

Regulatory Area	Previous Regulation (Before Decree 70/2023)	New Regulation (After Decree 70/2023)	Strategic Implication
Medical Prescriptions	Allowed the inclusion of both generic (INN) and commercial brand names on a prescription, per Law 25,649.⁶	Mandates the exclusive use of the generic name (INN) on all prescriptions. The pharmacist is then obligated to dispense the lowest-cost option available unless the patient explicitly requests otherwise.⁶	This is a direct and powerful assault on the traditional “branded generic” business model. It fundamentally weakens brand equity for off-patent drugs and shifts the locus of competition from influencing physician preference to securing pharmacy-level price advantages and supply chain dominance.
OTC Medication Sales	The sale of over-the-counter (OTC) medications was strictly restricted to licensed pharmacies, as mandated by Pharmacy Law 17,565.⁶	The restriction is eliminated, permitting the sale of OTC medications in any commercial establishment, such as supermarkets, kiosks, and convenience stores.⁶	Dramatically expands consumer access and creates new retail channels. However, it also introduces significant challenges for manufacturers regarding supply chain integrity, quality control outside the pharmacy environment, and managing a far more complex distribution network. It poses an existential threat to the traditional pharmacy business model.
Pharmacy Ownership	Pharmacy Law 17,565 and various provincial laws imposed significant restrictions on the types of legal entities that could own and operate pharmacies, often favoring individual pharmacists.⁶	Any legal entity permitted by current legislation (including corporations, or sociedades anónimas) can now establish and own a pharmacy. However, provinces retain the right to adhere to this deregulation or maintain their own stricter rules.⁶	This change is designed to inject capital and competition into the pharmacy retail sector. It opens the door for the expansion of pharmacy chains, new investment models, and potential market consolidation. The key variable will be the degree of adherence by major provinces like Buenos Aires.
Public Tenders	Law 18,875, the “Compre Argentino” (Buy Argentine) act, granted a clear and significant preference to bids submitted by domestic laboratories in all public procurement tenders.⁶	The preference established by Law 18,875 has been repealed. Foreign and domestic laboratories are now placed on an equal competitive footing for all public tenders.⁶	This is a game-changer for MNCs. It opens up the substantial public procurement market—a major source of revenue—to direct international competition. This could lead to increased product variety, downward pressure on prices for the state, and a new strategic imperative for MNCs to build public sector sales capabilities.

The Digital Transformation: Traceability, E-Prescriptions, and the New Data Imperative

Parallel to the wave of economic deregulation, a powerful digital transformation is reshaping the operational and commercial fabric of the Argentine pharmaceutical sector. This shift is being driven by two distinct but converging forces.

The first engine is ANMAT’s long-standing public health mission to ensure the integrity of the national drug supply. Years before the recent reforms, ANMAT established a mandatory National System of Drug Traceability. This system requires the serialization of pharmaceutical products, with each saleable unit bearing a unique identifier that allows for precise tracking and tracing throughout the entire distribution network.¹⁹ This comprehensive data reporting system is a powerful tool for combating counterfeiting and allows ANMAT to monitor the movement of pharmaceuticals and detect irregularities in real time.

The second, and more recent, engine is the new government’s broad economic agenda of modernization and efficiency. Decree 70/2023 acted as a massive accelerant for this trend. It amended existing laws to fully enable and encourage the use of electronic and digital prescriptions, removing the legacy requirement for handwritten orders.⁶ This was coupled with a mandate for the

digital storage of all prescription records and dispensing logs for a period of three years, replacing cumbersome physical logbooks.⁶

The convergence of these two trends—one driven by safety, the other by efficiency—creates a new strategic imperative for all companies. Success in the modern Argentine market requires the development and deployment of two distinct but interconnected digital capabilities:

A Compliance-Focused Capability: This involves robust, operational systems for serialization and data reporting to ensure full compliance with ANMAT’s traceability mandate. This is a non-negotiable cost of doing business.
A Commerce-Focused Capability: This involves the commercial and IT infrastructure needed to seamlessly integrate with the burgeoning ecosystem of e-prescription platforms and digital health networks. This is essential for capturing sales and market share in a new digital-first dispensing environment.

Companies that master both sides of this digital coin will be best positioned to thrive, leveraging data not only for compliance but also for commercial insight and competitive advantage.

Pathways to Market: Mastering the Drug Approval Process

Securing marketing authorization from ANMAT is the single most critical milestone in any product’s lifecycle in Argentina. The process is rigorous, multi-faceted, and unforgiving of error. However, it is also a system built on a clear, strategic logic. By understanding the different pathways available and the specific requirements for each, companies can navigate the process with greater speed, efficiency, and predictability.

The Standard Dossier: A Step-by-Step Guide to Registration

For any pharmaceutical product, the journey to market begins with the compilation and submission of a comprehensive registration dossier. While specific requirements vary by product type and registration pathway, the core components are consistent and reflect global standards. The standard process unfolds in a series of sequential steps:

Dossier Submission: The applicant, who must be a locally registered and licensed entity, submits an extensive package of documentation. This dossier must provide a complete picture of the product, including detailed information on its formula and composition, manufacturing processes, quality control methods and specifications, stability data, preclinical and clinical data demonstrating safety and efficacy, proposed packaging and labeling (in Spanish), and a detailed pharmacovigilance plan.²⁰
Evaluation and Assessment: ANMAT’s technical teams conduct a thorough review of the submitted dossier to ensure it meets all scientific and regulatory criteria. This is not a rubber-stamp exercise; the agency may issue requests for additional information or clarification if any part of the submission is found to be incomplete or inadequate.
Regulatory Decision: Upon successful completion of the evaluation, ANMAT issues a formal approval and assigns the product a registration number. This certificate of marketing authorization is the legal license to commercialize the product in Argentina.
License Validity and Renewal: The initial marketing authorization is valid for a period of five years. To maintain the registration, the holder must submit a renewal application at least 30 days prior to the certificate’s expiration, providing evidence of marketing and a sworn statement on its commercial status.²⁰

The timelines for this process are a critical factor in strategic planning. For standard small-molecule drugs, the approval process typically takes 12 to 18 months. For more complex products like vaccines and biologics, the timeline extends to approximately 24 months.²⁰

Strategic Navigation: The Decisive Power of Annex I and II

This standard process, however, is not the only route to market. The foundational Decree 150/1992 established a brilliant and pragmatic system of differentiated registration pathways based on a product’s country of origin and, more importantly, its commercialization status in countries with high-surveillance regulatory agencies.²² This system, which hinges on two lists of countries known as Annex I and Annex II, is the practical embodiment of ANMAT’s reliance strategy. Understanding these pathways is the single most important key to unlocking an efficient market access strategy.

The Article 4 Pathway: The “Fast-Follower” Express Lane

This is the abbreviated, fast-track route that every innovator company should aim for. It applies to drug products that have already received marketing authorization and are currently being marketed in at least one of the high-surveillance countries listed in Annex I (which includes the United States, Japan, and member states of the European Union).

The process under Article 4 is dramatically simplified. The single most important document in the submission is the Certificate of Pharmaceutical Product (CPP) issued by the health authority of the Annex I country. This CPP is not just proof of approval; it must explicitly state that the product is actively being commercialized in that market. With a valid CPP in hand, ANMAT’s review is streamlined, with an approval timeline of approximately 10 months. In many cases, the agency may rely so heavily on the judgment of its Annex I counterpart that it may not even request the submission of the full technical dossier.²²

The Article 5 Pathway: The Long Road for True Innovators

In stark contrast, the Article 5 pathway represents the full, unabridged review process. This route is reserved for products that do not qualify for the fast track. This includes:

New drug products manufactured in Argentina with no similar product already registered.
Drug products manufactured in an Annex II country (a list of countries with competent but not top-tier regulatory systems) that are not marketed in any Annex I country.
Drug products manufactured in any country not listed in Annex I or II.

The Article 5 pathway requires the submission of the complete dossier with all safety and efficacy evidence. It is a long, resource-intensive, and arduous process. The official timeline is stated as being “not less than 3 years”.²²

The vast chasm between the 10-month Article 4 process and the 3+ year Article 5 process creates an overwhelming strategic imperative. No commercially rational company would ever choose the long road if the express lane is available. This regulatory architecture effectively dictates Argentina’s place in the global launch sequence. It is structurally designed to be a “fast-follower” market. An efficient and cost-effective Argentine market access strategy is therefore completely dependent on a company’s prior regulatory and commercial success in the US or EU. The clock for a timely Argentine launch does not start until an Annex I approval has been secured and, critically, the product has been commercially launched in that reference market.

The Biologics Frontier: A Separate and Sophisticated Rulebook

Recognizing the unique complexity and manufacturing challenges associated with biological medicines, ANMAT has proactively developed a specific and sophisticated regulatory framework for this product class. This is not an ad-hoc adaptation of small-molecule rules but a purpose-built system codified in a series of key regulations:

Provision No. 7075/11: Establishes the general requirements for the registration of all biological medicines.²³
Provision No. 3397/12: Lays out complementary and more detailed requirements specifically for monoclonal antibodies and products obtained via recombinant DNA methods.²³
Provision No. 7729/11: Defines the specific abbreviated pathway for the approval of biosimilars.²³

Critically, the Argentine biosimilar pathway is explicitly based on the rigorous, science-driven model established by the European Medicines Agency (EMA). It requires applicants to conduct a comprehensive comparability exercise to demonstrate that their product is highly similar in terms of quality, safety, and efficacy to a designated biological reference medicine.²³

This early and deliberate adoption of a high-standard, globally respected framework demonstrates a mature and proactive regulatory posture. It has positioned Argentina as a leader in the Latin American biosimilars market.²⁵ For companies, it sends a clear signal: ANMAT is an experienced and knowledgeable regulator in the biologics space. Dossiers will be scrutinized against a high bar of scientific evidence, and companies should not expect any shortcuts or a lowering of standards for this complex and critical class of medicines.

From Lab to Clinic: The Clinical Trial Authorization Process

Argentina has made a concerted effort to position itself as an attractive and competitive destination for global clinical research. ANMAT is the central authority responsible for the direct regulation and supervision of all Phase I, II, and III clinical trials conducted in the country.²⁶

A cornerstone of the process is the non-negotiable prerequisite of ethical oversight. Before any clinical trial application can even be submitted to ANMAT, the protocol must first be reviewed and approved by an independent Ethics Committee (Comité de Ética en Investigación). This committee is charged with ensuring the protection of the rights, safety, and well-being of all trial participants.²⁶ The sponsor of the trial, whether a local or international entity, holds the primary responsibility for managing the entire regulatory filing process.²⁶

Recognizing that lengthy approval timelines are a major deterrent to investment, the government has taken decisive action to streamline the process. A recent regulation, Provision Nº 4008-2017, significantly reduced the target evaluation period. The standard timeline for ANMAT’s review and approval of a clinical trial application is now 70 working days. In a move that mirrors the drug registration system, this timeline can be further accelerated. For trials that have already been evaluated and approved by regulatory authorities in countries with high vigilance standards, the approval timeline in Argentina is shortened to just 55 working days.²⁹

This is not merely a bureaucratic efficiency measure; it is a clear instrument of industrial policy. Argentina is actively marketing its advantages for clinical research to the global pharmaceutical industry, highlighting its large, concentrated patient populations, its pool of highly qualified and reliable medical professionals and investigators, strong patient enrollment and compliance rates, and a track record of producing high-quality data that has performed well in FDA and EMA audits.²⁹ Global R&D and clinical operations departments should therefore view Argentina as a prime candidate for site selection in international multi-center trials.

Life After Launch: The Mandate for Proactive Surveillance

ANMAT’s regulatory oversight does not end when a marketing authorization is granted. The agency enforces a robust and continuous system of post-market surveillance to monitor the real-world safety and performance of all products on the market.

A comprehensive pharmacovigilance plan is a mandatory component of the initial registration dossier, signaling that lifecycle management is a condition of market entry from day one.²⁰ The foundational regulation,

ANMAT Disposition 2438/2000, establishes the core reporting requirements. Most critically, it mandates that any severe or unexpected adverse drug reactions occurring within Argentina must be reported to the agency within a tight timeframe of 10 days.³¹

A parallel and equally stringent system exists for medical devices, known as “Technovigilance.” This system, governed by Provision No. 9688/2019, requires all marketing authorization holders to implement a post-market surveillance system to collect and evaluate data from marketed products. It mandates the reporting of adverse events and any corrective safety actions undertaken by the company through a dedicated digital platform, ensuring rapid communication and response to potential safety issues.³²

The detailed, mandatory, and increasingly digitized nature of these post-market surveillance systems underscores a fundamental principle of the Argentine regulatory environment: marketing authorization is a privilege, not a permanent right. Companies must treat pharmacovigilance and technovigilance as core, ongoing operational functions, not as administrative afterthoughts. Robust, well-resourced, and locally compliant systems for safety monitoring and reporting must be in place from the day of launch, as they are a fundamental condition for maintaining the right to participate in the Argentine market.

The IP Minefield: A Guide to Patents and Data Exclusivity in Argentina

If ANMAT represents a challenging but ultimately navigable regulatory system, Argentina’s intellectual property landscape is a veritable minefield. For decades, it has been the single greatest source of friction between the innovator pharmaceutical industry and the Argentine state. The system is characterized by structural hurdles, deliberately restrictive patentability criteria, and a profound legal ambiguity surrounding data protection. Mastering this environment requires a radical departure from the standard global IP playbook and a clear-eyed understanding of the system’s underlying industrial policy objectives.

The Patent Paradox: Navigating INPI in a Non-PCT World

The authority responsible for examining and granting patents in Argentina is the Instituto Nacional de la Propiedad Industrial (INPI).³³ From the very outset, innovator companies face a major structural challenge:

Argentina is not a member of the Patent Cooperation Treaty (PCT).³³

This is a critical strategic handicap. The PCT provides a unified procedure for filing a single “international” patent application that can then enter the “national phase” in any of the 150+ member countries. Its absence in Argentina decouples the country’s patent process from the streamlined global strategy used for nearly every other major market. Instead of a simple national phase entry, companies must undertake a separate, direct national filing in Argentina. This is typically done by claiming priority from a first filing in another country under the 12-month window provided by the Paris Convention.³³ This parallel process significantly increases administrative complexity, translation costs, and the risk of inadvertently missing critical filing deadlines.

Compounding this structural issue is the notoriously slow pace of the INPI’s examination process. The average pendency for a patent application is a lengthy 5 to 7 years, creating a prolonged period of legal uncertainty for innovators.³³

This fragmented and opaque environment necessitates a dedicated “Argentina track” within any corporate IP department’s global filing strategy. It also elevates the importance of specialized intelligence tools. Platforms like DrugPatentWatch become indispensable for monitoring the status of these distinct national-level patent applications, tracking their slow progress through INPI, and identifying local court challenges or administrative actions that would be invisible to teams focused solely on major market and PCT data streams.

The 2012 “Guidelines”: A Deliberate Barrier to Follow-On Innovation

The most formidable obstacle in the Argentine patent system is not its structure, but its substance. In 2012, a series of Joint Resolutions (Nos. 118/12, 546/12, and 107/12), issued by INPI in concert with the Ministries of Health and Industry, established a set of exceptionally restrictive patentability examination guidelines specifically targeting chemical and pharmaceutical inventions.³³

These guidelines are not a neutral, technical interpretation of patent law. They are a clear and deliberate instrument of industrial policy designed to favor the country’s powerful domestic generic industry. Their core purpose is to prevent the “evergreening” of patents by systematically blocking protection for most forms of follow-on innovation. The guidelines explicitly declare a wide range of inventions as non-patentable subject matter, including:

New uses (second medical indications), even when drafted in the “Swiss-type” claim format.
Polymorphs (different crystalline forms of a known substance).
New formulations and compositions.
Different dosages of a known drug.
Salts, esters, ethers, and other derivatives of known compounds.
Active metabolites and pro-drugs.³³

The impact of these guidelines has been devastating for innovator patent portfolios. They are the primary driver behind the astonishingly low 10% grant rate for pharmaceutical patent applications, which stands in stark contrast to the 46% grant rate for applications in non-pharmaceutical fields.³⁴ Research has confirmed that the guidelines have been highly effective in achieving their policy goal of subjecting applications for secondary patents to more rigorous, and ultimately fatal, analysis.³⁷

The strategic implication is stark and unavoidable: a company’s global IP strategy, which often relies on building a “patent thicket” of follow-on inventions to prolong a product’s lifecycle, is utterly unviable in Argentina. It is futile to expect protection for an improved extended-release formulation, a more stable crystalline form, or a new pediatric dosage. The entire IP defense for an innovative product in Argentina must be concentrated on securing, defending, and enforcing the single core patent covering the new chemical entity (NCE) itself.

Data Exclusivity: The Legal Quagmire of Law 24.766

The weakness of the patent system is compounded by the profound ambiguity surrounding data protection. Argentina lacks a formal, explicit system of Regulatory Data Protection (RDP) or data exclusivity for pharmaceuticals, which in other countries provides a fixed period (e.g., 5 years in the US and Mexico, 8 years in the EU) during which a generic company cannot rely on the innovator’s clinical trial data to gain its own marketing approval.

In Argentina, any protection for the proprietary and costly clinical data package submitted to ANMAT hinges on the vague provisions of Law 24.766. This law offers a general protection for undisclosed information against “unfair commercial use”.³⁸ However, this protection has proven to be exceedingly narrow and difficult to enforce in practice, and has been a major point of contention in international trade relations for decades.³⁸

The central flaw is the law’s ambiguity. It protects the data from being physically copied or stolen, but it does not explicitly prohibit ANMAT from relying on or referencing the innovator’s previously submitted safety and efficacy data when reviewing a subsequent application for a generic product that demonstrates bioequivalence. This “indirect reliance” allows generic competitors to get to market without having to repeat the costly and time-consuming clinical trials, effectively undermining the commercial value of the innovator’s data package.

This combination of weak protection for follow-on patents and the absence of robust data exclusivity creates a “perfect storm” for innovators. It means that the moment the core NCE patent expires, the runway is clear for generic competitors to enter the market with extreme rapidity. This reality drastically compresses the commercially viable lifecycle of an innovative product in Argentina and places immense pressure on maximizing returns during the period of NCE patent protection.

Enforcement and Litigation: A Long, Winding, and Uncertain Road

For those patents that are granted, enforcement is a challenging and protracted affair. Patent infringement and validity challenges are adjudicated in the Federal Courts, not within INPI itself.⁴⁰ The judicial process is notoriously slow. A full trial can easily take

three to five years to reach a first-instance decision, with an appeal to the Court of Appeals adding another one to two years to the timeline.⁴⁰

Recent case law offers little comfort to innovators. In key decisions involving the patentability of polymorphs (in cases brought by Pfizer and Bayer), the Federal Courts have shown significant deference to the technical judgments of INPI’s patent examiners. The rulings have essentially held that the evidence presented by the companies was insufficient to overturn the examiner’s conclusion that the claimed polymorphs lacked an inventive step or were mere discoveries of inherent properties, consistent with the 2012 Guidelines.⁴¹ This establishes a very high bar for successfully challenging an INPI rejection in court.

Given the slow timelines and the judicial deference to the patent office, the strategic value of litigation in Argentina must be carefully assessed. For an innovator company, the decision to sue a potential infringer may be driven less by the probability of a definitive legal victory and more by the commercial value of the delay that the process itself creates. The decision to initiate litigation must be a cold, calculated business one. The substantial legal costs, which will be incurred over a potential 5-to-7-year legal battle, must be weighed against the commercial value of delaying a generic launch for that same period. For a blockbuster product with high revenues, the strategic delay created by litigation may be a sound investment. For a product with more modest sales, the return on investment from a long and uncertain legal fight is highly questionable.

Market Access & Commercial Strategy: Winning in a Volatile Environment

Securing regulatory approval and a patent from INPI are merely the first steps on the long road to commercial success in Argentina. The next, and arguably more complex, challenge is navigating the country’s fragmented payer landscape and developing a commercial strategy resilient enough to withstand the shocks of a hyperinflationary economy. Market access in Argentina is not a single event, but a continuous process of negotiation, adaptation, and financial discipline.

The Three-Tiered Payer System: Public, Social Security, and Private

It is a fundamental strategic error to view the Argentine healthcare market as a single, monolithic entity. It is, in fact, a highly fragmented system composed of three distinct and powerful sectors, each with its own funding mechanisms, patient populations, and decision-making processes.⁴²

The Public System: This sector is comprised of national, provincial, and municipal public hospitals and primary care clinics. It is funded primarily through general taxation and is the sole source of coverage for approximately 43% of the population, typically those outside the formal economy.⁴⁴
The Social Security System (Obras Sociales): This is the largest and most powerful segment of the market, covering roughly 48% of the population.⁴⁴ The
Obras Sociales are not government entities; they are over 300 independent health insurance schemes run by trade unions and funded by mandatory payroll contributions from employers (typically 6%) and employees (typically 3%).⁴³ They are the primary payers for the country’s formally employed workforce and their families.
The Private System (Prepagas): This sector consists of private, for-profit health insurance companies that provide coverage to about 15% of the population, funded by monthly premiums.⁴⁴ There is significant overlap with the social security system, as many individuals with private insurance also make mandatory contributions to an
Obra Social, sometimes redirecting those funds to their private plan.⁴⁴

The critical takeaway from this structure is that the Obras Sociales represent the single largest and most influential bloc of payers in the country. These are not passive administrators; they are powerful, independent entities, each with its own budget, its own formulary, and its own negotiation strategy. A successful market access plan cannot be monolithic. It requires distinct engagement strategies, value propositions, and negotiation tactics tailored to each of the three sectors. Securing favorable access and reimbursement terms with a handful of the largest and most influential Obras Sociales can often be more commercially impactful than achieving broad inclusion in the public hospital system.

Pricing and Reimbursement: The Roles of PMO and SUR/SURGE

While the payer landscape is fragmented, a national mandate provides a common foundation for coverage. The Programa Médico Obligatorio (PMO) is a government-defined basket of essential medical services and medications that all payers—public, social security, and private—are legally required to cover.⁴⁶

The PMO establishes the absolute floor for pharmaceutical coverage. The standard reimbursement level for most outpatient prescription drugs is 40% of their cost. However, this coverage rises to 100% for several high-impact categories, including:

Oncological medications
Treatments for chronic renal insufficiency
Drugs for patients with HIV/AIDS or cystic fibrosis
All medications administered during a hospital stay.⁴⁶

For particularly high-cost medicines, especially those used to treat rare or low-incidence diseases, a special reimbursement system exists. Originally known as the Unique Reimbursement System (SUR), it has been updated and is now called the Unique Reimbursement System for Disease Management (SURGE). This system, administered by the Superintendence of Health Services (SSS), provides a specific pathway for payers to receive reimbursement from a central solidarity fund for these exceptionally expensive treatments.⁴⁹

For an innovative, high-cost medicine, the PMO is the starting line, not the finish line. The primary market access goal is to secure inclusion in one of the 100% coverage categories or to gain reimbursement through the SURGE system. However, achieving this is merely the entry ticket to the market. The real commercial battle is fought in the subsequent, direct negotiations with individual payers. Ultimate success depends on securing favorable formulary placement and effective reimbursement terms with the key Obras Sociales and Prepagas, a process that is almost always driven by confidential discounts, rebates, volume-based agreements, and other sophisticated contracting mechanisms.⁴⁹

A Market Reliant on Imports

The Argentine medical equipment and device market mostly relies on imports, which account for around 80 percent of the total market. According to industry sources, imports of medical devices amounted to approximately $750 million between June 2023 and June 2024.

Source: Argentine Chamber of Medical Technology – CADIEM, as cited by the U.S. Department of Commerce.51

Surviving the Storm: Commercial Strategy in a Hyperinflationary Environment

The single greatest challenge to commercial operations in Argentina is the country’s chronic and severe hyperinflation. This is not a cyclical downturn; it is a persistent feature of the economic landscape that fundamentally alters all business calculations. In 2021, for example, while general inflation was already staggering, pharmaceutical drug prices were documented to have increased by an even greater 65.9%.⁵⁰

While the government has largely deregulated drug pricing, allowing manufacturers to set their own prices, this freedom is a double-edged sword. Payers, whose budgets are denominated in rapidly devaluing pesos, simply cannot keep pace with the price adjustments needed to maintain margins in real terms. This creates immense pressure on access, as payers are forced to implement stricter controls to manage their spiraling costs.

A critical flashpoint is the reimbursement mechanism for high-cost drugs. The payment rates set by the SUR/SURGE system are not updated frequently enough to keep pace with inflation. As a result, the real-terms value of the reimbursement collapses over time, leaving the payer (Obra Social or Prepaga) to cover a rapidly growing gap between the drug’s current price and the static reimbursement amount.⁵⁰

In this environment, traditional commercial strategies are doomed to fail. The single most important variable in all financial and commercial planning becomes the time value of money. A receivable that is paid 180 days after invoicing can lose a substantial portion of its real economic value by the time the cash is received. Therefore, commercial strategy must pivot away from a singular focus on maximizing the list price and towards a more sophisticated model that prioritizes the velocity and stability of cash flow. This means:

Negotiating contracts that feature the shortest possible payment cycles.
Linking prices to a more stable currency, such as the US dollar, wherever possible.
Building automatic inflation-adjustment clauses into all commercial agreements.
Potentially offering larger discounts in exchange for guaranteed prompt payment.

In the crucible of Argentine hyperinflation, a lower net price that is paid in 30 days is vastly superior to a higher list price that remains an uncollected receivable for six months. This reality must inform every negotiation, every contract, and every financial forecast.

Regional Benchmarking and Future Outlook

No market exists in a vacuum, and Argentina’s strategic importance is best understood in the context of its Latin American peers. For regional managers and global executives, the key is to recognize and leverage the profound differences between the region’s major markets. Treating Latin America as a single, homogenous bloc is a recipe for strategic failure.⁵²

Argentina vs. The Giants: A Comparative Analysis with Brazil and Mexico

The pharmaceutical landscape of Latin America is dominated by its three largest economies: Brazil, Mexico, and Argentina. While they share cultural and economic ties, their regulatory and IP frameworks are fiercely independent and present distinct sets of challenges and opportunities. A successful regional strategy requires a nuanced understanding of these differences.

The following table provides a high-level strategic snapshot comparing the three markets across the most critical variables for the pharmaceutical industry.

Table 2: Comparative Regulatory & IP Snapshot: Argentina vs. Brazil vs. Mexico

Factor	Argentina (ANMAT)	Brazil (ANVISA)	Mexico (COFEPRIS)
Regulatory Body	ANMAT	ANVISA	COFEPRIS
Typical Approval Timelines	Highly predictable. Approx. 10-12 months via reliance pathway; >3 years for full local review.²²	Historically long and variable, though recent efforts have aimed to reduce backlogs. A 2013-2016 cohort showed a median approval time of 795 days.⁵⁴	Approx. 12-18 months. Can be significantly faster via reliance pathways and the use of authorized third-party reviewers.⁵⁶
Reliance Model	Strong and formalized. The Annex I/II system is the cornerstone of the registration process, heavily relying on prior approvals from the US/EU.²²	Exists, but ANVISA is known for conducting more stringent, independent reviews and often requires additional local data, making it less of a pure reliance model.⁵⁷	Strong and formalized. COFEPRIS has official “equivalency” or reliance pathways for products approved by major reference authorities (FDA, EMA, Health Canada, etc.).⁵²
Patent Linkage System	None. There is no formal system requiring ANMAT to check for existing patents before approving a generic drug.	None. A previous requirement for ANVISA’s prior consent on patent applications, which acted as a quasi-linkage, was removed in 2021.⁵⁸	Strong and formal. COFEPRIS is legally obligated to check the “Linkage Gazette” published by the patent office (IMPI) and cannot approve a generic if a relevant patent is listed.⁵²
Data Exclusivity	Weak and ambiguous. Protection is based on a general trade secret law (Law 24.766) that does not explicitly prevent regulatory reliance on innovator data.³⁸	None. Brazilian law explicitly excludes products for human use from data package exclusivity provisions.⁵⁹	Formalized. Mexico provides a 5-year period of data exclusivity for new chemical entities, consistent with its international trade agreement obligations.⁶⁰
Primary IP Challenge	The highly restrictive 2012 Patentability Guidelines, which systematically reject patents for most forms of follow-on innovation (new uses, formulations, polymorphs, etc.).³⁶	The significant patent prosecution backlog at the patent office (INPI), which leads to extremely long delays in obtaining patent grants.⁶²	Widespread counterfeiting and piracy, coupled with systemic challenges in effectively enforcing IP rights through the judicial and administrative systems.⁶³

This comparison reveals a critical strategic insight: Mexico offers the strongest and most predictable IP protection of the three, with a robust patent linkage system and a formal data exclusivity period. Brazil presents the greatest regulatory hurdles in terms of timelines and independent review requirements. Argentina occupies a unique middle ground: its regulatory reliance model offers one of the fastest and most predictable pathways to market in the region, but this is counterbalanced by the weakest and most challenging IP environment.

The Road Ahead: Future Trajectory and Expert Perspectives

What does the future hold for the Argentine pharmaceutical market? While nominal market growth forecasts remain positive, projecting a market size of over $14 billion by 2030 ¹, the path to that future will be anything but linear. The overarching risk factor remains the country’s profound and persistent economic and political volatility.⁶⁶

The key trend to monitor is the ongoing tug-of-war between the new, aggressive deregulation agenda and the deeply entrenched systems of protectionism and state intervention. Will the free-market reforms of Decree 70/2023 prove durable, or will they be reversed by a future administration? The answer will determine the long-term commercial landscape.

Other critical trends include the continued growth and increasing sophistication of the domestic biotechnology and biosimilar sector, which has become a significant export engine for the country ⁵, and the simmering potential for a future overhaul of the restrictive 2012 IP guidelines. There are nascent signs that the current administration may view these guidelines as a barrier to innovation and investment, with some officials publicly questioning their validity.⁶⁹

This complex interplay of forces suggests that the future of Argentina’s pharmaceutical market is likely to unfold at two different speeds.

The “Fast Track” will be driven by the commercial and retail deregulation agenda. We can expect continued intensification of competition, downward pressure on prices for off-patent medicines, and the emergence of new business models in the pharmacy and distribution sectors.
The “Slow Track” will involve the more gradual, politically contentious evolution of deep-seated structural issues. This includes the fundamental framework for intellectual property, national manufacturing policy, and the chronic budget and inflation-related constraints of the payer system.

A winning long-term strategy in Argentina will require the agility to operate at both of these speeds simultaneously. It will demand the ability to compete aggressively on price and supply chain efficiency in the newly liberalized commercial environment of today, while also engaging in patient, persistent, and data-driven policy shaping to help build a more stable and innovation-friendly ecosystem for tomorrow.

Key Takeaways

For the senior executive, investor, or strategist, the exhaustive detail of Argentina’s pharmaceutical landscape can be distilled into a series of core, actionable conclusions. These takeaways provide a strategic framework for decision-making in this complex and dynamic market.

Argentina is a “Fast-Follower” Market by Design: The drug approval system, with its highly efficient “Article 4” reliance pathway, is structurally designed to prioritize drugs already approved and marketed in the US or EU. A successful Argentine launch strategy is therefore inseparable from and subsequent to a successful global launch strategy in a major reference market.
Decree 70/2023 is a Commercial Game-Changer: The recent deregulation is not a minor adjustment. The mandates for generic-only prescribing and the liberalization of OTC sales and pharmacy ownership are fundamentally rewiring the commercial playbook. The historical “branded generic” model is under existential threat, and competitive advantage is shifting decisively towards price, supply chain efficiency, and pharmacy-level strategy.
IP Strategy Must Be Radically Re-Engineered: The standard global approach of building a “patent thicket” to protect follow-on innovation is unviable in Argentina due to the highly restrictive 2012 Patentability Guidelines. IP protection must be laser-focused on securing and defending the core patent for the new chemical entity. The absence of robust data exclusivity further compresses the commercially viable product lifecycle.
The Payer Landscape is Three Markets in One: Success in market access requires distinct strategies for the three core payer segments: the public system, the powerful union-run Obras Sociales, and the private Prepagas. The Obras Sociales represent the largest and most influential segment and should be a primary focus of any engagement strategy.
Hyperinflation Demands a Cash-Flow-First Commercial Model: In an environment of chronic hyperinflation, maximizing the list price is a secondary concern. The primary commercial objective must be to maximize the velocity and stability of cash flow by negotiating short payment cycles, inflation-adjusted terms, and potentially dollar-linked pricing.
ANMAT is a Credible and Stable Gatekeeper: Despite the surrounding political and economic chaos, ANMAT’s “autarchic” status and deep integration with global regulatory bodies make it a consistent, predictable, and science-driven institution. Its reliance on international standards provides a stable foundation for regulatory planning.
Argentina is a Competitive Hub for Clinical Research: Deliberate policy changes have created streamlined and accelerated approval pathways for clinical trials, making the country an attractive destination for global R&D investment, thanks to its strong medical infrastructure and patient populations.

Frequently Asked Questions (FAQ)

1. Given the recent deregulation under Decree 70/2023, is a direct-to-market strategy now preferable to partnering with a local Argentine firm?

This is a critical strategic question with no single right answer; it depends entirely on the company’s profile and objectives. The deregulation, particularly the opening of public tenders to foreign firms and the potential for new pharmacy ownership models, certainly makes a direct-to-market approach more feasible than ever before. An MNC with a strong portfolio of innovative, patented drugs and the resources to build a local subsidiary may find this attractive. However, for companies focused on off-patent products or those new to the region, partnering with an established local player like Roemmers or Bagó still offers immense advantages. These firms possess unparalleled knowledge of the complex distribution channels, deep relationships with the powerful Obras Sociales, and decades of experience navigating the country’s economic volatility—assets that are difficult and costly for an outsider to replicate. The optimal choice requires a careful trade-off between control and local expertise.

2. With the 2012 Patentability Guidelines still in place, is there any viable IP strategy for protecting follow-on innovation in Argentina, or is it a lost cause until the rules change?

For the most part, protecting typical follow-on innovations like new formulations, polymorphs, or second medical uses through the patent system is a lost cause under the current guidelines. The 10% grant rate for pharmaceutical patents speaks for itself. However, this does not mean all lifecycle management is impossible. The strategy must shift from patent law to regulatory and commercial domains. For example, for a complex biologic, generating extensive local clinical data for a new indication could create a significant barrier to entry for a biosimilar competitor, even without a patent. Similarly, investing in a unique drug-device combination could create a commercial moat based on user preference and training, even if the device itself is not separately patented. The strategy moves from legal exclusion to creating practical, data-driven, and commercial barriers to entry.

3. How should our financial planning and P&L modeling for an Argentine product launch be adapted to mitigate the risks of hyperinflation?

Standard P&L models are inadequate for Argentina. Financial planning must be re-engineered around a few core principles. First, all revenue and cost projections must be modeled in a stable currency (e.g., USD) and then converted to ARS using a dynamic, frequently updated forecast for inflation and devaluation. Second, the “Days Sales Outstanding” (DSO) metric becomes the single most critical assumption, as the real value of revenue erodes with every day a payment is delayed. Sensitivity analysis should be run on DSO, not just on price or volume. Third, the P&L should include explicit line items for currency conversion costs and potential losses on foreign exchange. Finally, commercial contracts should be structured to mitigate this risk through clauses that mandate shorter payment terms (e.g., 30-60 days), interest penalties for late payments, and, where negotiable, pricing linked to the official USD exchange rate.

4. What are the key leading indicators we should monitor that would signal a genuine, systemic shift in Argentina’s IP and market access policies?

Beyond headline-grabbing decrees, there are several more subtle leading indicators to watch. For intellectual property, the key signals would be: (1) an official move by the government to formally review or rescind the 2012 Patentability Guidelines; (2) the appointment of a new head of the patent office (INPI) with a publicly pro-innovation track record; and (3) any legislative proposal to join the Patent Cooperation Treaty (PCT). For market access, the indicators would be: (1) a reform of the SUR/SURGE system that introduces a mechanism for regular, inflation-adjusted updates to reimbursement rates; and (2) any move to establish a formal, transparent Health Technology Assessment (HTA) body whose decisions are binding on payers, which would bring more predictability to reimbursement for innovative medicines.

5. Considering ANMAT’s reliance model, what is the optimal timing for initiating the Argentine submission process relative to our FDA and EMA filings to ensure the fastest possible path to market?

The optimal timing is precise and counterintuitive for those accustomed to simultaneous global filings. The clock for the fast-track “Article 4” pathway in Argentina does not start upon FDA or EMA approval. It starts when you can obtain a Certificate of Pharmaceutical Product (CPP) that confirms the product is actively marketed in that reference country. Therefore, initiating the Argentine dossier preparation in parallel with the US/EU submissions is wise, but the actual submission to ANMAT should be timed to occur immediately after the commercial launch in the first Annex I country. Submitting before you can secure a “marketed status” CPP risks being shunted to a slower review track or facing delays while waiting for the correct documentation, negating the entire advantage of the reliance pathway. The sequence should be: FDA/EMA Approval -> Commercial Launch in US/EU -> Obtain “Marketed Status” CPP -> Immediately Submit to ANMAT.