PERU: DIGEMID will recognize GMPs from Several other LATAM countries

January 7, 2017

The Peruvian governement just issued a modification to the law that govern medicines (*) that, among other changes, is mandating the Peruvian authority to recognize Good Manufacturing Practice certificates (GMPc) issued by "Level 4" regional reference National Regional Authorities (NRA) as per the PAHO/WHO NRA assessment scheme. Pharmaceutical drug products that have a GMPc from any of these authorities will not be required to have their manufacturing sites/facilitys inspected by the Peruvian DIGEMID. This will facilitate the access to market to products manufactured in countries with Level 4 NRA and will decrease the number of GMP audits required for products manufactured in other regions.

The revisions to the law will have to cascade into lower level regulations in orde to be fully implemented; this is expected to occur within 2-3 months.

DIGEMID will accept GMPc issued by regulatory authorities from these countries:

  • Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT).

  • Brazil: Agencia Nacional de Vigilancia Sanitaria. Ministério da Saúde (ANVISA)

  • Chile: Instituto de Salud Pública de Chile (ISP – ANAMED)

  • Cuba: Centro para el Control Estatal de la Calidad de los Medicamentos. Ministerio de Salud Pública (CECMED)

  • Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)

  • Mexico:  Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)

(*) Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios.

 

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