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:
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[X]
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Notified measure enters into force - date: 27
December 2024
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[X]
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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Notified measure withdrawn or revoked - date: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:
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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.