Committee on Technical Barriers to Trade - Notification - Ecuador - Pharmaceutical products containing new chemical entities - Addendum

NOTIFICATION

Addendum

The following communication, dated 1 August 2024, is being circulated at the request of the delegation of Ecuador.

 

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Title: Normativa Técnica Sanitaria para otorgar el periodo de exclusividad de datos de prueba de Productos Farmacéuticos que contengan nuevas entidades químicas (Sanitary Technical Regulations on the granting of a period of exclusivity for test data for pharmaceutical products containing new chemical entities)

 

Reason for Addendum:

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Comment period changed - date:

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Notified measure adopted - date:

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Notified measure published - date:

[X]

Notified measure enters into force - date: 27 December 2024

[X]

Text of final measure available from[1]:

www.controlsanitario.gob.ec

https://members.wto.org/crnattachments/2024/TBT/ECU/final_measure/24_04956_00_s.pdf

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Notified measure withdrawn or revoked - date:

Relevant symbol if measure re-notified:

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Content or scope of notified measure changed and text available from1:

New deadline for comments (if applicable):

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Interpretive guidance issued and text available from1:

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Other:

 

Description: Sanitary Technical Regulations on the granting of a period of exclusivity for test data for pharmaceutical products containing new chemical entities.

This Addendum No. 1, submitted by the Republic of Ecuador, concerns the Sanitary Technical Regulations on the granting of a period of exclusivity for test data for pharmaceutical products containing new chemical entities. These Regulations establish the requirements and procedure according to which the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA) will grant a period of exclusivity for test data or other undisclosed information on safety and efficacy, for pharmaceutical products containing new chemical entities.

The Sanitary Technical Regulations on the granting of a period of exclusivity for test data for pharmaceutical products containing new chemical entities were issued by ARCSA pursuant to Resolution ARCSA-DE-2024-023-DASP of 28 June 2024 and published in Official Journal No. 604 of 19 July 2024. The Resolution will enter into force six months after its signature, without prejudice to its publication in the Official Journal.

The authority responsible for this regulatory text is ARCSA.

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

PuntocontactoOTC@gmail.com

palvarezc@produccion.gob.ec

cyepez@produccion.gob.ec

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[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.