TBT BSN | Notification

Notification Detail :: G/TBT/N/ECU/525/Add.1

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Partial amendment to "Resolution ARCSA-DE-001-2019-JCGO issuing the guidelines for notifying the Sanitary Registry of general medicines and biological products"

Objective

Consumer information, labelling (TBT); Prevention of deceptive practices and consumer protection (TBT); Protection of human health or safety (TBT)

Product Covered

Proyecto de reforma parcial a la “Resolución ARCSA-DE-001-2019-JCGO por medio de la cual se expiden las directrices para realizar notificaciones al registro sanitario de medicamentos en general y productos biológicos”

Document Notification

Link to ePing

HSCODE

ICSCODE

11.120 - Pharmaceutics; 11.120 - Pharmaceutics

Keywords

Human health; Human health

Specific Regions

Description

Resolution ARCSA-DE-2024-030-DASP Draft partial amendment to "Resolution ARCSA-DE-001-2019-JCGO issuing the guidelines for notifying the Sanitary Registry of general medicines and biological products"  1 This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final measure/change to the measure/interpretative guidance can be obtained. G/TBT/N/ECU/525/Add.1 - 2 -   The Republic of Ecuador hereby notifies and publishes Addendum No. 1 to the partial amendment to Resolution ARCSA-DE-001-2019-JCGO issuing the guidelines for notifying the Sanitary Registry of general medicines and biological products. The regulation has been issued pursuant to Resolution ARCSA-DE-2024-030-DASP of 3 July 2024 by the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA, Doctor Leopoldo Izquieta Pérez). The regulation will enter into force six months after its signature, without prejudice to its publication in the Official Journal. Text available from: Ministerio de Producción, Comercio Exterior, Inversiones y Pesca (Ministry of Production, Foreign Trade, Investment and Fisheries), Subsecretaría de Calidad (Under-Secretariat for Quality), Organismo Nacional de Notificación (National Notification Authority) TBT enquiry point: Patricio Álvarez Plataforma Gubernamental de Gestión Financiera - Piso 8, Bloque amarillo, Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira Quito, Ecuador Tel.: (+593-2) 3948760, Ext. 2252/2254 Email: Puntocontacto-OTCECU@produccion.gob.ec palvarezc@produccion.gob.ec PuntocontactoECU@gmail.com cyepez@produccion.gob.ec __________

Notified Document

1:File here

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/ECU/525/Add.1

Link to ePing

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