DRAFT GUIDELINE FOR PUBLIC CONSULTATION "FDA GUIDELINE ON IDENTIFICATION AND DATA CAPTURE FOR PHARMACEUTICAL TRACEABILITY"

This guideline was developed in response to the requirements of WHO Global Benchmarking Market Surveillance and Control function Indicator MC.01.05 which requires an existence of legal provisions and regulations for placing product unique identification number on outer packaging. The guidelines takes its root from the Ghana National Pharmaceutical Traceability Strategy documents developed by the Ministry of Health (MOH) and the FDA which aims to improve the health status of all citizens of the country by ensuring the availability of quality, safety, and effective medical products as well as their rational use, including the ease of traceability. This guideline adopts GS1 standards which are universally recognized standards and basic principles that would allow them to track and trace products from the source to the patient and back again through the supply chain system. This Guideline therefore conforms with global standards and provides simplicity and consistency by promoting universal applicability and optimal functionality across the globe for all industry sectors. All stakeholders in the pharmaceutical supply chain were duly consulted in the development of these guidelines.

Link to the draft guideline below

DRAFT GUIDELINE FOR PUBLIC CONSULTATION "FDA GUIDELINE ON IDENTIFICATION AND DATA CAPTURE FOR PHARMACEUTICAL TRACEABILITY"

Comments should be sent to this email enforcement@fda.gov.gh referencing the document page and line number.