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

NOTIFICATION

The following notification is being circulated in accordance with Article 10.6.

 

1.

Notifying Member: ECUADOR

If applicable, name of local government involved (Articles 3.2 and 7.2):

2.

Agency responsible:

Agencia Nacional de Regulacion, Control y Vigilancia Sanitaria, ARCSA (National Agency for Sanitary Regulation, Control and Surveillance)

Ciudadela Samanes, Av. Francisco de Orellana y Av. Paseo del Parque. Bloque 5, Guayaquil - Ecuador

Tel.: (+593-4) 3727 440

Website: https://www.controlsanitario.gob.ec

Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:

Subsecretaría de Calidad (Under-Secretariat for Quality)

Ministerio de Producción, Comercio Exterior, Inversiones y Pesca, MPCEIP (Ministry of Production, Foreign Trade, Investment and Fisheries)

Address: Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira, Piso 8, Bloque amarillo

Tel.: (+593-2) 3948760, Ext. 2254 or 2272

Email:

puntocontactoOTCECU@produccion.gob.ec;

puntocontactoECU@gmail.com;

cyepez@produccion.gob.ec;

Website: www.produccion.gob.ec

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], other:

4.

Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Draft Sanitary Technical Regulations to grant exclusivity for test data for pharmaceutical products containing new chemical entities.

The notified draft Regulations establish the procedure by which the ARCSA grants a period of exclusivity for test data or other undisclosed information on safety and efficacy, which require considerable effort to obtain, for pharmaceutical products containing new chemical entities, in accordance with the provisions of the Organic Code of the Social Economy of Knowledge, Creativity and Innovation (COESCI).

5.

Title, number of pages and language(s) of the notified document: Proyecto de Normativa Técnica Sanitaria para otorgar exclusividad de datos de prueba de Productos Farmacéuticos que contengan nuevas entidades químicas (Draft Sanitary Technical Regulations to grant exclusivity for test data for pharmaceutical products containing new chemical entities) (11 pages, in Spanish)

6.

Description of content: The notified draft Regulations establish the procedure by which the ARCSA grants a period of exclusivity for test data or other undisclosed information on safety and efficacy, which require considerable effort to obtain, for pharmaceutical products containing new chemical entities, in accordance with the provisions of the Organic Code of the Social Economy of Knowledge, Creativity and Innovation (COESCI).

The notified Sanitary Draft Regulations are applicable to and binding on all natural and legal persons, whether domestic or foreign, governed by public or private law, that request a period of exclusivity for test data or other undisclosed information on safety and efficacy requiring, which require considerable effort to obtain, for pharmaceutical products containing new chemical entities, as well as on all sanitary registration applicants requiring registration of a medicine containing a chemical entity within the previously mentioned period of exclusivity.

7.

Objective and rationale, including the nature of urgent problems where applicable: Prevention of deceptive practices and consumer protection; Protection of human health or safety

8.

Relevant documents:

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9.

Proposed date of adoption: To be determined

Proposed date of entry into force: Six months after adoption

10.

Final date for comments: 60 days from notification

11.

Texts available from: National enquiry point [X] or address, telephone and fax numbers and email and website addresses, if available, of other body:

Contact and/or national enquiry point:

Subsecretaría de Calidad

Ministerio de Producción, Comercio, Exterior, Inversiones y Pesca (MPCEIP)

Address: Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira, Piso 8, Bloque amarillo

Tel.: (+593-2) 3948760, Ext. 2254 or 2272

Email:

puntocontactoOTCECU@produccion.gob.ec;

puntocontactoECU@gmail.com;

cyepez@produccion.gob.ec;

https://members.wto.org/crnattachments/2023/TBT/ECU/23_14486_00_s.pdf