Alerta Administrativa: Importación de Vacunas COVID 19
Published date | 12 January 2021 |
Law Firm | Rubio Leguía Normand |
El 11 de enero entró en vigencia el Decreto Supremo Nº 002-2021-SA, mediante la cual se aprueba el Reglamento para el Registro Sanitario Condicional de Medicamentos y Productos Biológicos (en adelante, el “Reglamento”).
El objetivo del Reglamento es establecer disposiciones reglamentarias sobre el artículo 8 de la Ley N° 29459, Ley de los Productos Farmacéuticos Dispositivos Médicos y Productos Sanitarios, modificado por la Ley N° 31091, referido a la obligatoriedad del registro sanitario; para regular el registro sanitario condicional de medicamentos y productos biológicos con estudios clínicos en Fase III.
Al respecto, el Reglamento establece que mediante el “Registro Sanitario Condicional” se autoriza la fabricación, importación, almacenamiento, distribución, comercialización, dispensación, expendio o uso de medicamentos y productos biológicos para la prevención y tratamiento de enfermedades gravemente debilitantes o potencialmente mortales, que dan lugar a una emergencia declarada por riesgos o daños a la salud pública, reconocida por el Poder Ejecutivo o por la Organización Mundial de la Salud y, tiene una vigencia de un (01) año. Así también el Reglamento señala que pueden solicitar dicho registro, quienes cuenten con la autorización sanitaria como laboratorio de productos farmacéuticos o droguería. Esta norma – junto a la Ley N° 31091 – es de suma importancia toda vez que:
- Viabiliza la célere obtención del Registro Sanitario Condicional para las vacunas que se importarán para prevenir el coronavirus SARS-CoV-2 (COVID 19).
- De acuerdo al artículo 4 de la Ley N° 31091, se estableció que la adquisición, distribución y disponibilidad de medicamentos y vacunas del coronavirus SARS-CoV-2, será gratuita y universal ...
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