ECU/511/Add.1
WTO/TBT
EC Equateur
  • 13 - Environnement, Protection de la santé, Sécurité
2022-08-20
2022-06-21

The purpose of this sanitary technical regulation is to establish guidelines for the process of approval of clinical trials for products in research and the certification of products for human use and consumption and of establishments subject to sanitary control and surveillance that come within the competence of ARCSA., during health emergencies or national or international emergency situations; as well as the criteria for the sanitary control and surveillance thereof. This sanitary technical regulation is binding on all natural or legal persons, whether domestic or foreign, governed by public or private law, that request the approval of a clinical trial for a product in research or undertake the registration, re-registration or amendment of the sanitary certificate for products for human use and consumption; and those that request the certification, extension, amendment or renewal of the certificate of good practices for establishments subject to sanitary control and surveillance that come within the competence of ARCSA, during health emergencies or national or international emergency situations.

Proyecto de Normativa Técnica Sanitaria para la aprobación de ensayos clínicos y la certificación de productos de uso y consumo humano y sus establecimientos, durante emergencias sanitarias o situaciones de emergencia, nacionales o internacionales (Draft Sanitary Technical Regulation for the approval of clinical trials and the certification of products for human use and consumption and their establishments, during health emergencies or national or international emergency situations).

Draft Sanitary Technical Regulation for the approval of clinical trials and the certification of products for human use and consumption and their establishments, during health emergencies or national or international emergency situations.

By means of this Addendum No. 1, the Republic of Ecuador advises that the Sanitary Technical Regulation for the approval of clinical trials and the certification of products for human use and consumption and their establishments, during health emergencies or national or international emergence situations, has been issued pursuant to Resolution ARCSA-DE-2022-008-AKRG of 10 May 2022 by the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA, Doctor Leopoldo Izquieta Pérez), in order to facilitate trade. The notified measure will enter into effect on the date of its publication in the Official Journal (30 May 2022).

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)