Traceability is "the ability to track the history, application or location of an entity (activity, process, product, organization, person) using information stored in logs.
GS1 Colombia has supported INVIMA in this topic, by studying the way in which GS1 Standards can make feasible Law 1122 of 2007, section 34, sub-section d: INVIMA is accountable for ensuring the identification of medicines at any stage of the distribution chain, from production to the end consumer, through a signalling methodology, with the aim of avoiding counterfeiting, tampering, expiration and smuggling.
To this end, GS1 Colombia has been working in a pilot based in the application of international standards in keeping with the recommendations given by Universidad Nacional.
16 Labs participate voluntarily (Multinational and national companies) and each of them defined the stakeholders to be involved: IPS (pharmaceutical services), wholesalers and their respective Drugstores.
Twenty-five active principles were defined in different pharmaceutical forms.
The pilot deliverables are as follows:
- Characterize information and product flows in the health sector.
- Identify improvement opportunities in the processes of traceability and visibility of the supply chain.
- Design and validate a model of traceability and visibility that allows integrating the information of each of the nodes, including inspection, surveillance and control activities.
- Develop a prototype that might be tested in a real operation.
- Document the effects, learnings and recommendations leading to improvement of the prototype.
- Establish minimum technical-functional requirements of the technological platform needed to deploy a traceability system.
- Establish the road map for a nationwide implementation.