#Tatmeen is not EMVO | European Medicines Verification Organisation and
#EMVO is not FDA Supply Chain Security Act ( #DSCSA).
Each national regulatory authority decide the model that suits it objectives and its market.
Treating them as one model leads to confusion, and poor implementation decisions.
𝑾𝒉𝒂𝒕 𝒊𝒔 𝒂 𝑻𝒓𝒂𝒄𝒆𝒂𝒃𝒊𝒍𝒊𝒕𝒚 𝑴𝒐𝒅𝒆𝒍?
Traceability means full visibility of a medicine pack across the entire supply chain:
Manufacturer ➜ Distributor / Agent ➜ Warehouse ➜ Pharmacy / Hospital
At any point in time, the system can answer: ““𝑊ℎ𝑒𝑟𝑒 𝑒𝑥𝑎𝑐𝑡𝑙𝑦 𝑖𝑠 𝑝𝑎𝑐𝑘 𝑋 𝑟𝑖𝑔ℎ𝑡 𝑛𝑜𝑤?”
This is the model implemented in #Tatmeen, and it represents the direction #Egypt is moving toward.
𝐖𝐡𝐚𝐭 𝐢𝐬 𝐚 𝐕𝐞𝐫𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐌𝐨𝐝𝐞𝐥?
A completely different approach,The manufacturer serializes each pack
The pharmacy scans the pack at dispensing and decommissions it
All intermediate stakeholders (distributors, warehouses) perform verification only
This is the model implemented by #EMVO in Europe.
Inside the #EMVO Model, How Verification Works at Scale
The European Commission defined a highly structured architecture built around two main layers:
𝐄𝐮𝐫𝐨𝐩𝐞𝐚𝐧 𝐇𝐮𝐛 (𝐨𝐩𝐞𝐫𝐚𝐭𝐞𝐝 𝐛𝐲 𝐄𝐌𝐕𝐎):
=The main place for storage of master data
=A gateway for the transmission of manufacturer data to the national systems .
=Data reconciliation on repackaging activities, i.e., maintaining a link between original and repackaged product batches, is exclusively performed on the European Hub.
=A single entity from which national systems can obtain revised/new product serialization data.
=Information on product recalls.
𝐍𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐒𝐲𝐬𝐭𝐞𝐦𝐬 (𝐨𝐩𝐞𝐫𝐚𝐭𝐞𝐝 𝐛𝐲 𝐭𝐡𝐞 𝐍𝐌𝐕𝐎𝐬):
=Verification platforms that pharmacies or other parties can use to check a product’s ‘authenticity’
=Uses the interface to the Hub
=Contain the relevant product serialization data
=Receives revised/new product serialization data from the EU Hub
#EMVS which is EMVO'S system supported by a very strong Alerts and Notifications management system, which i wrote an article about it i will leave it in the first comment.