The Model Regulation for Pharmaceutical Traceability Template and Guidance document is intended for use by Ministries of Health (MoHs) and/or national drug regulatory authorities (NDRAs) in implementing verification and/or traceability strategies. Foundational to achieving verification and/or track and trace implementation is the presence of an appropriate incentive structure and clear requirements for the entities involved. Regulation is commonly used to accomplish this framework.
This resource may be used to develop a statutory instrument that provides a legal framework defining roles and responsibilities as a basis for a verification and/or traceability systems. Typically a regulation is supported by guidelines that provide additional detail enabling those entities subject to it to comply. This resource may be used alongside the Guideline for Identification and Labelling of Pharmaceutical Products Template and Guidance and the Guideline for Pharmaceutical Product and Location Master Data Template and Guidance.
