Partial Amendment to the Substitute Technical Regulation to authorize the exceptional importation and importation for the purposes of donation of medicines, biological products, medical devices and biochemical and diagnostic reagents

REFORMA PARCIAL A LA RESOLUCIÓN ARCSA-DE-016-2020- LDCL, POR MEDIO DE LA CUAL SE EXPIDE LA NORMATIVA TÉCNICA SUSTITUTIVA PARA AUTORIZAR LA IMPORTACIÓN POR EXCEPCIÓN E IMPORTACIÓN POR DONACIÓN DE MEDICAMENTOS, PRODUCTOS BIOLÓGICOS, DISPOSITIVOS MÉDICOS Y REACTIVOS BIOQUÍMICOS Y DE DIAGNÓSTICO (Partial amendment to Resolution ARCSA-DE-016-2020- LDCL, issuing the Substitute Technical Regulations authorizing the exceptional importation of and importation for the purposes of donation of medicines, biological products, medical devices, and biochemical and diagnostic reagents)

The Republic of Ecuador hereby notifies Resolution ARCSA-DE-2025-040-DASP, through which the National Agency for Health Surveillance, Regulation and Control (ARCSA), Doctor Leopoldo Izquieta Pérez, issues the Partial amendment to Resolution ARCSA-DE-016-2020- LDCL, issuing the Substitute Technical Regulations authorizing the exceptional importation of and importation for the purposes of donation of medicines, biological products, medical devices, and biochemical and diagnostic reagents.

The purpose of aforementioned Resolution is to comply with the ruling of the Constitutional Court as set out in Judgement No. 679-18-JP/20 and joined cases, dated 5 August 2020, which establishes that "litigated medicines" (medicines that have been the subject of lawsuits in order for patients to access them) that do not have a national health registration must have a health registration issued by a high-level health supervisory authority, to ensure that the product meets quality standards.

It should be noted that Resolution ARCSA-DE-2025-040-DASP, amending Resolution ARCSA-DE-016-2020-LDCL, is not considered a technical barrier to trade because: it does not incur a cost for the applicant; the intended purpose of importing the products covered by Resolution ARCSA-DE-016-2020-LDCL is not to market them at the national level, but rather it applies only to the National Health System, the patient in their own right or their legal representative, in the following instances:

·        A health emergency declared by act of a public authority;

·        For specialized treatments not available in the country, duly justified;

·        For people suffering from catastrophic, rare, or orphan diseases, duly justified;

·        For the purpose of human clinical research, the protocol for which has received prior approval from ARCSA;

·        For the supply of the public sector through international organizations;

·        Other instances defined by the national health authority; and

·        Other instances provided for in the Organic Law on Health.