News

They approve the "List of Documents Considered Equivalent to the Certificate of Good Manufacturing Practices"

La DIGEMID a través de la Resolución  Directoral Nº 026-2020-DIGEMID-DG-MINSA, publicada el 28 de abril del 2020 en el Diario Oficial “El Peruano”, aprobó el “Listado de Documentos Considerados Equivalentes al Certificado de Buenas Prácticas de Manufactura” para la Inscripción y Reinscripción en el Registro Sanitario de Productos Farmacéuticos. 

Así mismo, en el Artículo 3º de la citada Resolución Directoral se establece que los documentos no considerados en el listado aprobado en el artículo 1°, podrán ser consultados ante la DIGEMID, a efectos de ser considerados equivalentes a los certificados de Buenas Prácticas de Manufactura, e incorporados en dicho listado de ser el caso.

Source: Official Gazette "El Peruano"

Recent posts

Extension of the declaration of Sanitary Emergency

The MINSA included in the PNUME for the Health Sector, the product Medicinal Oxygen 93% gas for inhalation

MINSA ordered the publication of the Regulation Project that establishes specific provisions for conducting Clinical Trials with Medical Devices

The MINSA approved the Sanitary Directive for the use of Oxygen in Institutions Providers of Health Services and home use

MINSA approved the Technical Document: National Vaccination Plan against COVID-19

The MINSA orders the publication of the Technical Document project: Manual of Citizen Participation in the elaboration of the PNUME

MINSA approved the Technical Document: Management of people affected by COVID-19 in hospitalization services

MINSA approved the technical document: Guidelines for the exceptional health authorization of medical devices in the research stage

Urgent decree that dictates extraordinary measures to facilitate and guarantee the acquisition, conservation and distribution of vaccines against COVID-19

The MINSA plans to publish a draft ministerial resolution that resolves to include in the PNUME for the health sector, the medicinal oxygen product 93% gas

DIGEMID safety modifications: For pharmaceutical specialties containing "MELOXICAM"

The MINSA approves the update of the scale for infractions and sanctions to pharmaceutical and non-pharmaceutical establishments of the regulation of pharmaceutical establishments

DIGEMID safety modifications: For pharmaceutical products containing "Bacillus Clausii"

DIGEMID safety modifications: For pharmaceutical specialties containing "MONTELUKAST"

DIGEMID safety modifications: For pharmaceutical specialties containing "LORCASERIN"

DIGEMID safety modifications: For pharmaceutical specialties that contain "FENOTEROL"

The MINSA modified the Regulation of Narcotic Drugs, Psychotropic Drugs and Other Substances subject to Sanitary Inspection

The MINSA approved the "Technical Health Standard that establishes the ethical criteria for the promotion and advertising of pharmaceutical products, medical devices and health products"

Health Directive for the Control and Surveillance of in vitro Diagnostic Devices is approved: Rapid and Molecular Tests for COVID-19

The MINSA incorporated the file called: IVERMECTINA Oral Solution 6 mg/ml in the Technical Health Standard for the Manufacture of Pharmaceutical Preparations