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Argentina Drug Registration Process

Streamlining Pharmaceutical Registration in Argentina: A Comprehensive Guide to Navigate the Regulatory Process for Drug Approval

MoH: Ministry of Health of Argentina

MoH website: https://www.argentina.gob.ar/salud

Regulatory Authority: The National Administration of Drugs, Food and Medical Technology

Link for Regulatory Authority: https://www.argentina.gob.ar/anmat

Applicable Regulation: DECREE NO. 150/1992 ESTABLISHES THE RULES FOR THE REGISTRATION, PREPARATION, DIVISION, PRESCRIPTION, SALE, MARKETING, EXPORT AND IMPORT OF MEDICINES.

Biologics/Drugs/Pharmaceutical/Medicine/OTC- general registration procedure and requirement in Argentina

 Before pharmaceuticals are made available to the public in Argentina, they must undergo a comprehensive product registration process with ANMAT. To complete this process, you must provide extensive documentation outlining the product’s composition, manufacturing processes, quality control methods, and clinical data proving its efficacy and safety.

  1. Submission of Documents:

This is the first stage in the registration process for medications; the documents contain comprehensive information on pharmaceutical items.

List of product documents for submission-

  1. Application form provided by ANMAT.
  2. Manufacturing and quality control information.
  3. Product composition report.
  4. Stability data of the product.
  5. Preclinical and clinical data.
  6. Pharmaceutical packaging and labelling.
  7. Pharmacovigilance plan.
  8. Import and export licenses.
  1. Evaluation and assessment:

ANMAT reviews the submitted documentation to determine if the pharmaceutical product meets regulatory criteria.

  1. Regulatory discission:

The pharmaceutical product is approved and ANMAT issues a registration number when it satisfies all requirements. This number shows that the product has passed the required regulatory criteria and has undergone a comprehensive review.

  1. Post-Market Surveillance:

ANMAT determines the product’s registration based on the evaluation. ANMAT uses post-market surveillance to keep an eye on the product’s efficacy and safety even after it has been registered and placed on the market.

5.Labelling: Should be in Spanish.

Timeline for approval of pharmaceutical products:  12 to 18 months for small molecules and 24 months for vaccines and biologicals.

Registration fees of pharmaceutical products: 10.000 ARS (Argentine pesos). These fees vary depending on the type of product to be. The fees are updated every year by ANMAT.

License validity:  5 Years.

License renewal: 30 days prior to the certificate expiration date and should include the following documents:

  1. Written request.
  2. Sworn statement – marketed/non-marketed status.
  3. Evidence of marketing.
  4. Certified copy of the original certificate.
  5. Copy of last approved labelling texts.