Table 1 Template of parameters for comparison of the content of the NRA legislation and guidelines^a

Legislative Provisions or Enabling parameters

Legal provision allowing importation of unregistered medicines

Legal provision for allowing approval of donations

Guidelines

Quality Parameters

 Requirement for GMP Approval (Inspection/Desk Reviews/ Reliance/ Recognition)

 Requirement for Pre-Distribution Analysis

 Requirement for Batch Specific Data such as Certificate of analysis

 Requirement for Pre-Distribution Inspection

Efficacy Parameter

 Requirement for Registration in the Country of origin or Recognized Jurisdictions

Safety Parameters

 Requirement for Post Market Surveillance

 Requirements Specific for Dosage Forms

 Requirement for Product Specific Data (Stability, Pharmacovigilance Reports, Product Quality Reviews)

 Requirement for product brochure containing chemical, pharmaceutical, pre-clinical pharmacological and toxicological data and where applicable, human, or animal pharmacological and clinical data with the medicine concerned

 Requirement for Supply History

Other Parameters

 Requirement for assessing if there is a registered alternative or the registered option has not been imported in the past 6 months

 Requirement for a Dossier to have been submitted

 Requirement for Availability in EML

 Requirement for rationale why an unregistered medicine is required

 Requirement for restriction to emergencies, disease outbreak, neglected disease and shortages