Regulatory

Promedico’s regulatory department is responsible for the quality of the products and pharmaceuticals flowing through the supply chain, from import approval application, through arrival of a shipment from overseas, to delivery to the customer.

Relabeling, which is one of Promedico’s added-value services, is managed and controlled by the Regulatory Department, which operates according to GMP requirements and MoH procedures and handles approval of new labels/brochures, process control for relabeling of medicinal products, and reporting to the QP on compliance prior to product release.

The department is also in charge of obtaining import permits for named patient pharmaceuticals, dispensing and tracking, release of lots for sale after MoH inspections (medical foods and infant foods), and inspection of temperature sensors contained in shipments.

The department handles complaints relating to quality and pharmacovigilance, returns of pharmaceuticals from customers, and recalls; the department manages a database of customers authorized to purchase drugs according to MoH guidelines; and manages the inventory and dispensing of narcotic drugs and clinical trials (including import approvals issued by the MoH), and dispensation of dialysis solutions for home dialysis patients.

Beginning in January 2012, upon entry into effect of the Pharmacists Regulations (Good Manufacturing Practices), the regulatory department has been in charge of the reserved sample warehouse, where samples of all the lots imported by Promedico are retained and stored.

The Regulatory Department represents an extensive professional knowledge base, and supports numerous organizational processes including those involving multiple functions and departments.

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