Regulatory Affairs Services in Argentina

Strategic regulatory affairs services in Argentina providing risk-free product approvals preventing delays.

Services We Offer

Practical Regulatory Affairs Solutions In Argentina

Argentina is the third largest pharmaceutical market in Latin America, following Brazil and Mexico. The healthcare sector continues to grow with an increased demand for advanced therapies and drugs. Foreign companies see this as an opportunity and are seeking to enter the market and launch their products.

However, entering the market requires a good understanding of Argentina’s regulatory system. Argentina is regulated by the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (in Spanish) or National Administration of Drugs, Food and Medical Device (in English) (ANMAT), which is a decentralized body under the Ministry of Health of the Argentine Nation. ANMAT is responsible for regulating product registration, quality control, pharmacovigilance, clinical trials, and combating counterfeit drugs.

At Artixio, we offer consulting services for regulatory affairs in Argentina, helping companies approach the market with confidence through complete regulatory support and local guidance.

Regulatory Authorities in Argentina

Regulatory Body	Focus Area
Administración Nacional de Medicamentos, Alimentos y Tecnología Médica(ANMAT)	Pharmaceuticals, medical devices, cosmetics, food supplements
Servicio Nacional de Sanidad y Calidad Agroalimentaria(SENASA)	Veterinary products, animal nutrition
Instituto Nacional de Alimentos(INAL) - (within ANMAT)	Nutrition products, labeling, safety evaluation

Regulatory Affairs Lifecycle in Argentina

1. Regulatory Classification According to ANMAT

Classify the product based on the composition and active components, primary function or mechanism of action, intended use and route of administration, labeling claims and presentation format.
It is classified into pharmaceuticals, medical devices (Classes I–IV), food supplements, cosmetics (Grades 1 and 2), and biologics, each regulated by specific resolutions (e.g., Disposición 2318/2002 for devices).
Classification helps to understand the further regulatory path of the product (simplified or full review along with the level of supporting data required).

2. Appoint a Local Registration Holder

A qualified local registration holder (legal entity in Argentina) is appointed, which acts as the official Marketing Authorization Holder (MAH). They should be approved by ANMAT before dossier submission. MAH is responsible for all the steps of product registration including the submission, additional requirements, communication with ANMAT and post market compliance.

3. ANMAT Technical Documentation and Filing Format

Technical documentation should be translated into Argentinian Spanish language. ANMAT dossier does not follow ICH CTD format for documentation, instead it has its own formats and includes:

a. Administrative Module:

Application form, power of attorney, legal declarations, fee receipts (tasa ANMAT)

b. Technical Module:

Product specifications and formulation data
Manufacturing process flowcharts
Quality control and batch release procedures
Method validation reports
Stability data under Zone IVb conditions
Clinical and non-clinical evidence (where applicable)
Sample packaging, instructions, and labels in Spanish

5. Dossier Submission and ANMAT Review

Once the dossier is complete, it is submitted through ANMAT’s GDE (Gestión Documental Electrónica) platform or in paper, depending on the type of product class.
Evaluation consists of administrative validation, technical review by ANMAT’s internal team of experts. ANMAT may issue a Nota de Observación request in case of any query or additional documents needed. Applicants typically receive 30–60 days to respond to deficiency letters. No response or incomplete answers result in file closure.

4. Get GMP Certification

If the product is manufactured outside Argentina, it is important to submit proof that the site follows Good Manufacturing Practices (GMP). ANMAT accepts GMP certificates from few recognized authorities such as FDA, EMA, and may require the following documents:

A detailed site master file
Copies of inspection reports
Batch release procedures
Equipment validation protocols

For some categories, ANMAT inspects the site themselves, in cases if the product is high-risk or if documents are incomplete. GMP compliance must be confirmed before ANMAT completes dossier review.

6. Application Approval and Registration

After the application is approved, ANMAT grants a Registro Sanitario license to the company/manufacturer that allows them to import, distribute, and sell their products in Argentina.

To initiate the commercial distribution and marketing of the products, the company should register warehouses, importers, get approved labeling and packaging.

7. Post Marketing Compliance

ANMAT demands post marketing compliance of the product from the MAH. It is required to maintain the quality, efficacy and safety of the product. The companies are expected to:

Report Adverse events
File regulatory updates (e.g., label changes, site changes, shelf-life updates) under the Modificación de Registro process
Submit annual reports or Periodic Safety Update Reports (PSURs)

Why Artixio for Argentina Regulatory Affairs

We, at Artixio, help you to register your product without any delay in Argentina in accordance with ANMAT regulations. Our team of experts work closely with local experts and regulatory authorities to manage each stage of the approval process. Contact our Argentina Regulatory Affairs Expert now for a hassle-free market entry.

FAQs

1. Do I need a local partner to register products in Argentina?

Yes, most registrations with ANMAT or SENASA require a local legal representative or affiliate. Artixio can assist with this setup.

2. How different are ANMAT requirements from EU or U.S. regulations?

ANMAT follows some global benchmarks but has its own dossier structure, language requirements, and labeling rules. Direct reuse is not always possible.

3. What’s the average registration time for pharmaceuticals or devices?

Pharmaceutical approvals can take 12–18 months, while devices and cosmetics may move faster if all documents are in place.

4. Is Spanish translation mandatory for all documents?

Yes, ANMAT and SENASA require Spanish translations of technical documents, product inserts, and labels.

5. How does Artixio support long-term regulatory needs in Argentina?

We offer full lifecycle services — from initial registration to periodic updates, compliance audits, safety submissions, and renewals.

6. Which certificates are required for drug registration with ANMAT?

For imported drugs, ANMAT typically requires a Certificate of Pharmaceutical Product (CPP) issued by the competent authority in the country of origin.