News

Web application to report the discontinuation of the manufacture or import of medicines or biological products, and their reactivation

El 24 de enero del 2020, la DIGEMID publicó en su Portal Web Institucional el comunicado dirigido a los titulares de registro sanitario o certificado de registro sanitario,  en el que informa que se encuentra a disposición la Aplicación Web Registro de Discontinuación Temporal y Definitiva de la Fabricación o Importación de Medicamentos y Productos Biológicos, a efectos de cumplir lo establecido en el Título III del Decreto Supremo N° 026-2019-SA.

Este Aplicativo se encuentra en la sección Sitio de interés de la página de inicio del Portal Web Institucional de DIGEMID con el nombre “MEDICAMENTOS Y P. BIOLÓGICOS DISCONTINUADOS”.

Recent posts

Web application to report the discontinuation of the manufacture or import of medicines or biological products, and their reactivation

DIGEMID updates the list of products that to date are not subject to the granting of sanitary registration

Draft technical document published: manual of good pharmacovigilance practices

DIGEMID statement on the mercury component in medical devices and cosmetic products

DIGEMID statement on nonylphenol and ethoxylated nonylphenol components

DIGEMID ordered safety modifications in the technical data sheet and/or in the insert of the medicines that contain "ondansetron"

CAN approves resolution 2108: "Regulation of decision 833: Harmonization of legislation on cosmetic products"

They provide for the publication of the draft supreme decree that modifies article 94 of the regulation of pharmaceutical establishments

DIGEMID statement regarding the batch release of biological products: Vaccines or derivatives of human plasma

They provide for the public opinion the draft regulation that regulates the major changes of pharmaceutical products with sanitary registration

Control and surveillance actions in relation to the product Losartan

DIGEMID ordered security modifications in the technical data sheet and/or insert of the pharmaceutical specialties that contain "Diethylstilbestrol"

Control and surveillance actions in relation to the Ranitidine product

DIGEMID ordered safety modifications in the data sheet and/or insert of biological products containing "Ustekinumab"

List of foreign manufacturing laboratories of pharmaceutical products that are pending GMP certification by DIGEMID (period: 2010 to August 31, 2019)

PROCEDURES ENABLED IN VUCE

They publish an annex to ministerial resolution No. 796-2019 / MINSA "Technical health standard that regulates the preparation of the risk management plan for pharmaceutical products"

Approve technical health standard that regulates the preparation of the risk management plan for pharmaceutical products

Approve the technical guide: inspection guide for good manufacturing practices for pharmaceutical products

IMPORT OF THE PRODUCT UNDER RESEARCH AND COMPLEMENTARY PRODUCTS