Proyecto de Reglamento que regula las condiciones para la presentación de los resultados de control de calidad del primer lote y subsiguientes lotes de productos farmacéuticos (Draft Regulation laying down requirements for the submission of quality control results for the first and subsequent batches of pharmaceutical products) (8 pages, in Spanish)

The purpose of the notified Regulation is to establish the requirements for the quality control of the first and subsequent batches of pharmaceutical products, and the requirements for the submission of the results of such quality control, prior to marketing or distribution on the Peruvian market.