Pharmacovigilance Unit

Introduction

 

Pharmacovigilance is the monitoring of the reactions produced by medications. Institutions such as the World Health Organization (WHO) and the Health Organizations have designed systems that facilitate the detection of adverse reactions caused by drugs to avoid as far as possible the risks to consumers. The National Pharmacovigilance Center (CNF) that is part of the Federal Commission for Protection against Health Risks (COFEPRIS) is responsible for receiving reports by professionals of health and laboratories that detect suspected adverse reactions of medicines, vaccinations and medical devices. The information on the Adverse Reactions can be generated by notification of the medical institutions or public consumers that maintain adequate monitoring of these reactions in order to report the symptoms caused by the medicine used. Technovigilance must ensure that any medical device that is commercialised in Mexico meets the requirements as indicated by the manufacturer. Otherwise, corrective actions are taken in order to reduce the occurrence of adverse events/incidents to offer greater protection and security for its users.

 

Objective and importance

 

Regisan's Pharmacovigilance Unit aims to provide support to holders of health records of medical devices and/or their legal representative in Mexico, to perform the proper surveillance of the devices, thus ensuring the safety of the products and having the protection to patients.

 

Specific activities of the Pharmacovigilance Unit

 

  • Drug Traceability Standardized Operating Procedures
  • Capacitación a todo el personal involucrado en el manejo de los medicamentos
  • Control and protection of documents
  • Initial notification of adverse events/incidents
  • Follow-up and final report
  • Informe de farmacovigilancia (renovación de registros)
  • Compliance with notification dates to the CNFV
  • Coordinated participation with the CNFV in accordance with the provisions established by the CNFV
  • Among others


Notification Process

 

  • All notifications must be sent to the CNFV in writing.
  • Cumplir con los tiempos de notificación del reporte inicial, de seguimiento y final de acuerdo a lo especificado en la Norma NOM-220-SSA1-2016 emitida por el Centro Nacional de Farmacovigilancia de COFEPRIS.
  • Renewal of the marketing authorization.


REGISAN service modalities

 

-Internal organization and training of pharmacovigilance areas. -External presentation of the specific activities of the Pharmacovigilance Unit Organization and training of personnel. -

 

Literature References

 

  • NOM-220-SSA1-2016

 

Requires pharmacovigilance
Mode A

Registration of allopathic medicines, vaccinations and blood products, new national manufacturing molecule.

Requires pharmacovigilance
Mode B

Registry of allopathic medicines, vaccinations and blood products nationally manufactured (Generics).

Requires pharmacovigilance
Mode C

Registration of allopathic medicines, vaccinations and blood products foreign manufacture (new molecule).

Requires pharmacovigilance
Mode D

Registration of allopathic medicines, vaccinations and blood products, foreign manufacture (Generic).

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