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ArgentinaPharmacovigilance Argentina

Pharmacovigilance Argentina

We design and implement your Good Pharmacovigilance Practices Program according to your company's needs.

The GOOD PHARMACOVIGILANCE PRACTICES PROGRAM is designed as a quality system based on national and international guidelines, covering the detection, evaluation, validation, follow-up, reporting and filing of adverse events of products during their commercialization.

In Argentina, ANMAT Resolution No. 706/93 created the National Pharmacovigilance System. Through Dispositions No. 3870/99 and 2438/00 and Circular 03/08, the Pharmaceutical Industry was incorporated into the system, requiring the reporting of serious and unexpected adverse reactions, as well as non-serious ones on a defined, periodic basis. Disposition 5358/12 approved the Good Pharmacovigilance Practices. FP CLINICAL PHARMA can act before the Health Authorities as the party responsible for the safety of your company's medicines.

What does your laboratory need?

Basic — Case Report Management

  • Management of suspected adverse reaction reports
  • Coverage of all medicinal specialties, up to 6 reports per month
  • Use of the F.P. VigiPharma Platform
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Superior — Case Reports + Advisory

  • Everything included in the Basic Package
  • Advisory for the Pharmacovigilance Officer of up to 2 hours per month
  • Support with day-to-day regulatory decisions
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Literature Search

  • Systematic surveillance of worldwide scientific literature by medicinal specialty
  • Identification and assessment of safety signals
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PSUR — Periodic Safety Update Reports

  • Preparation of Periodic Safety Update Reports (PSUR/PBRER) under ANMAT Disposition 5358/12
  • Portfolio diagnosis and regulatory classification (innovator/biosimilar/RMP/vaccines) to determine the frequency and date of each PSUR
  • Preparation and maintenance of the PSUR schedule aligned with the EMA calendar
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RMP — Risk Management Plans

  • Design and drafting of the Risk Management Plan under ANMAT Disposition 5358/12
  • Includes description of safety specifications and epidemiology of the indications
  • Routine pharmacovigilance plan, additional plan (if applicable) and risk minimization plan (if applicable)
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